CHIGURU Adivasi Birth Cohort Study: A Protocol for Examining the Effects of Parental Substance Use on Child Development in Southern Indian Adivasi Communities

CHIGURU Adivasi Birth Cohort Study: A Protocol for Examining the Effects of Parental Substance Use on Child Development in Southern Indian Adivasi Communities | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol CHIGURU Adivasi Birth Cohort Study: A Protocol for Examining the Effects of Parental Substance Use on Child Development in Southern Indian Adivasi Communities Prafulla Shriyan, Yogish Channa Basappa, Giridhara R Babu, Tanya Seshadri, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3897825/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background : Children of parents who use tobacco and alcohol are at increased risk for a variety of adverse outcomes, including emotional, social, behavioral, and cognitive problems. Parental smoking and alcohol use can also lead to nutrient deficiencies in children, as well as poor birth outcomes such as restricted growth. Among adivasi communities, disproportionately higher malnutrition, and increasing substance use could be contributing to persistent and inter-generational developmental disadvantages. However, there is limited research on the long-term health implications of parental substance use on children after birth. The proposed study will examine the effects of parental substance use on child growth and developmental outcomes in adivasi communities in southern Karnataka. Methods: The research design involves a longitudinal cohort study, in which lactating/postnatal women and their partners along with other household members are recruited. This is the first large-scale adivasi birth cohort study to examine the effects of substance use among parents and other family members after delivery on infant growth and developmental indices. Information on the household socio-demographics, wealth index, diet, delivery information, depression, social support, morbidity status, substance use details, and child development with anthropometric details in baseline and follow-up visits shall be recorded. The study targets to recruit a sample size of 650 newborns and family members. The primary outcome is child growth parameters whereas the secondary outcome is early childhood development in terms of gross motor, fine motor, language, and social domain. The total duration of the study is five years (2021-2026). Discussion : The study offers a comprehensive examination of parental substance use and its effect on child development in an adivasi community in south India. This will help researchers identify significant risk thresholds and better understand the consequences of parental substance use on infant development utilizing the prospective adivasi family cohort. The study will also address the long-term under-representation and neglect of such studies among adivasi populations and enable a long-term research engagement with the community. The study could inform policy and practice related to addressing substance use disorders and their effects on children. The public health implications include prioritizing the issues of parental substance use, and identification of early interventions to prevent adverse health outcomes in children. Adivasi cohort parental substance use child development tribal health Figures Figure 1 Figure 2 Figure 3 Figure 4 Background The Developmental Origins of Health and Disease (DOHaD) framework suggests that exposure to poor nutrition, stress, and environmental chemicals early in life, determines the risk of short-term (physical growth and neurodevelopment) and long-term (non-communicable diseases such as coronary heart disease, hypertension or type 2 diabetes) health outcomes in children.( 1 , 2 ) The prevalence of smoking among women in India is low(0.5% in women Vs 5% in men)( 3 ), possibly due to the prevailing gender norms in many societies including its intersections with other social determinants (like, caste, class, location, and ethnicity) that have shaped sex-based and other differences in tobacco/substance use wherein women generally tend to have lower prevalence of substance use compared to men.( 4 , 5 ) National Family Health Survey (NFHS-5, 2019-21) data shows around 8.9% of women (above 15 years) use tobacco and 38% of men (above 15 years), while alcohol consumption is relatively 1.3% among women and 18.8% among men.( 6 ) Substance use throughout a person's life is influenced by a range of factors, starting at an early age. Several risk factors associated with substance use are genetic factors, stress, peer group influence, traumatic life events, such as physical abuse and neglect, low socioeconomic status, and adverse environmental factors, such as media, parents, and families. ( 7 ) Clinical investigations of parents diagnosed with substance use disorders suggest that parental substance use has considerable negative effects on infant and child development. ( 8 – 10 ) A survey done among women of nine developing nations on the use of tobacco during pregnancy shows that 9% of pregnant women in Karnataka and 34.2% of pregnant women in Orissa use various forms of tobacco products during their pregnancy.( 11 )Further, estimates from NFHS, 2019–2020 show that the prevalence of tobacco use in pregnant women and lactating women was 2.5% and 3.2% respectively.( 12 ) Women and children are frequently exposed to indoor tobacco smoke in homes where smoking is permitted..( 13 ) Second hand smoke exposes women to the same range of tobacco smoke toxins that active smokers do. It is likely that exposure to SHS results in issues as well, but at a lower relative risk.( 10 ) Findings from a systematic review shows that there is an increased risk of low birth weight in nonsmoking pregnant women who are exposed to SHS. Also, it showed other adverse foetal health consequences including ( 8 ) congenital malformation and stillbirths. Children who have grown up in environments where parents or other family members consume alcohol or tobacco products serve as role models for the younger generation.( 9 ) Children of tobacco and alcohol users experience a wide variety of adverse effects, including emotional, social, behavioural, and cognitive difficulties. ( 14 , 15 ) The study investigating the predictors on child physical characteristics shows that a mother’s nutritional status, history of alcohol use influences the physical growth characteristics of her child. ( 16 ) The supply of vital nutrients is not available to the foetus when the mother’s nutritional state is compromised by exposure to smoking and drinking; this could cause abnormalities in the foetus. As a result, a combination of tobacco and alcohol usage is linked to poor newborn outcomes, including restricted growth.( 17 ) Tobacco use has an indirect effect on mother and child nutrition since it can divert resources from other essentials that a household may need to pay for, such food, medical care, and education. ( 18 ) Second-hand smoke exposure, which is common in family settings also affects children and has the same negative impact as active smoking. ( 19 ) In 2014, a consortium consisting of public health researchers, Non-Governmental Organisations(NGO) and the community-based organisation (CBO) of the Soliga adivasi community in Chamarajanagar to set up a participatory action research program on maternal health supported by the WHO Alliance for Health Policy & Systems Research.( 20 ) Based on this study, in 2017, the multi-method Towards Health Equity & Transformative Action on Tribal Health (THETA) study was taken up which examined the underlying drivers of inequities in adivasi health.( 21 ) The current study is one of several components of a multi-component and multi-disciplinary research centre on adivasi health being established through close partnerships with the community-based adivasi collective by researchers in order to respond to the specific and neglected health problems that were reported by THETA study findings. Given the lack of laws or socio-cultural frameworks limiting indoor tobacco and its effects on children, characterising the pathways through which this affects children and mitigating these acquire public health importance.( 18 ) Study done among adivasi communities in Kerala, India shows higher proportion of children suffer from anthropometry failure.( 22 ) Besides the nutritional programmes there is persistent increase in malnutrition in adivasi children ( 23 ). The children of parents who use substance use are at risk of experiencing direct effect such as parental abuse or neglect and indirect effect such as insufficiency of resources( 24 ) The issue of parental substance use and its contributions to physical and psychosocial development of children is even more urgent with respect to adivasi children. Furthermore, adivasi communities are often deemed hard-to-reach due to geographical, socio-cultural barriers and ethical issues that result in their under-representation in research studies, more so in longitudinal public health research. There are no peer-reviewed prospective cohort studies done among that specifically examine Adivasi communities in India or other LMICs. Since a child's health is primarily determined by the environment in which they live, adult family members' use of tobacco and alcohol may have a negative impact on their capacity to provide childcare and expose their children to more harmful environmental factors. Given the higher proportion of malnutrition among adivasi children in Chamarajanagar, this prospective study aims to investigate the effect of parental use of tobacco and alcohol on child malnutrition and early childhood developmental outcomes The study also aims to explore the interaction effect between parental tobacco and alcohol use with the child developmental indices outcomes and identifies individual/household level factors that could protect adivasi children from the harmful effects of parental substance abuse. Methods and design Aims and objectives: This study aims to prospectively assess the harmful effects of parental use of tobacco and alcohol on the risk of adverse child health and developmental outcomes. The primary objective of the study is to explore the relationship between parental use of tobacco and alcohol on child malnutrition(Figure 1) Our secondary objectives are; Investigate the relationship between parental use of tobacco and alcohol on child developmental delay (Figure 2); Examine the interaction between parental use of alcohol and tobacco on the child outcomes and Identify individual/household level factors that could protect adivasi children from harmful effects of parental substance use. Hypotheses: Parental exposure to substance use is associated with stunting (low height for age), wasting(low weight for height), and being underweight(low weight for age). Parental exposure to substance use is associated with global developmental delay in children Study design: A prospective cohort study based in Chamarajanagar district from March 2023 to October 2026. In this longitudinal cohort study, we recruit lactating/postnatal women and their partners along with other household members. This is the first large-scale adivasi birth cohort study to examine the effects of substance use among parents and other family members after delivery on infant growth and developmental outcomes till three years of age. We are collecting both household and individual Information. The trained team collects data on mothers’ perinatal care and services, general morbidy status, mental health status, social support and anthropometric details. The information on household, including dietary diversity and exposure to air pollution, along with other family members substance use history and anthropometric details will be collected. Study setting Chamarajanagar district, the southernmost district in the Karnataka, southern India (Figure 3), ranks 22 nd among 31 districts in the Human Development Index. The district is pre-dominantly rural (83% of its population in rural areas) and thickly forested (48% of its area). The district has been divided into five talukas (administrative sub-divisions: Hanur, Kollegal, Yelandur, Gundlupet, Chamarajanagar). As per the 2011 census, 11.8%(36920) of the district population ( 2011 census) is scheduled tribe (ST). Communities that are legally accorded the ST status are identified for provision of affirmative action in the form of education and employment benefits. Within the ST, our study identifies three communities (Soliga, Jenukuruba & Bettakuruba) that self-identify as Adivasi (translates to firstcitizens in multiple Indian languages). Multiple Adivasi communities in Karnataka are most disadvantaged within the ST. The three Adviasi communities included in this study live in and around the legally protected forest areas in the district and have faced historical displacement for the purposes of wildlife conservation. Their historical claims over their own lands have received legal ratification only since 2006 with the legislation of the Forest Rights Act which aimed to correct historical injustices faced by them during colonial and post-colonial times. Although they historically practiced shifting cultivation, they now live in podus or haadis (relatively small villages often attached to a larger non-adivasi village nearby and not having its own administrative identity). Their main occupation is dependent on harvest and sale of non-timber forest produce or daily wage labour in coffee estates and other non-adivasi businesses. All three adivasi communities included in this study have their own distinct language, food and cultural identity which is rapidly changing over the last few decades, often with deleterious effects on their overall adivasi identity. Access to healthcare and education is still a challenge for many Adivasi communities in India possibly due to social and historical factors and not only due to individual behavioural factors such as literacy and awareness. (25, 26) Sample size estimation: Using THETA study findings as a reference (cite THETA dataset), keeping 44% underweight among under-five adivasi children. The sample sizes are estimated for frequency of population keeping a 95% confidence interval and calculated sample size for 40000 adivasi population of Chamarajanagar. We obtained a sample size of 376, after adding 40% of the non-response rate, the final sample size obtained is 650. The target subjects(newborns) and family members are recruited from the adivasi community. Eligibility criteria: Newborn baby : Newborns, recruited within 90 days of birth with no major birth complications (a severe illness that required hospitalization) and parents agreed to provide written informed consent. Mother : Lactating women (not more than 90 days after delivery) aged 18 years or more, having no major medical complications, being mentally able to respond to the interviewer's questions, and agreeing to give informed consent. Family members including siblings: Those who residing in the same households and those who available at the time of the field visit will be included. Assent will be obtained from children aged between 7 to below 18 years, whereas for children below 7 years parental consent will be obtained, and those who are over the age of 18 would be requested for their written consent. Exclusion criteria : New-born baby : Twin birth, hospitalized for initial three months, and parents not willing to provide written informed consent. Mother and family members : Choose to withdraw their consent, not willing to participate in a cohort study, Individuals with severe mental illness or other diseases, and those who do not provide written consent. Participants recruitment: The potential list of adivasi pregnant women residing in Chamarajanagar district is mapped by obtaining pregnant women list from the Chamarajanagar district reproductive and child health officer, Ministry of Health and family welfare every two months and the team also verifies the existence of any pregnancy cases at the adivasi hamlets through inquiry on presence of pregnancy cases in the area during their day of visit from the Zilla Budakattu Girijana Abhivruddhi Sangha (ZBGAS), Taluk Budakattu Girija a Abhivruddhi Sangha the indigenous people’s welfare association run by members of the Soliga people at district and Taluk. Accredited Social Health Activists (ASHA) who cater services to the selected hamlets are also being contacted regularly by the research team to update the pregnant women list for the adivasi setting. Participants are recruited by visiting the participant household in the community. Pregnant women who completed 34 weeks of gestation are being contacted by the research team to enquire about the pregnancy status, plan of delivery and expected date of delivery. Upon confirmation of delivery in any Adivasi family, the field supervisor/ data collection team will contact the health worker of the concerned area (ANM or ASHA) to plan a household visit. The head of the household, the newborn’s mother, father and other family members of the household will be approached by the research team further for consent after providing detailed information on purpose of study. Data collection flow : After confirming the delivery, the data collection team will contact the household members and show a study information video in Kannada language of Soliga dialect, not lasting more than five minutes which has a snapshot of the adivasi cohort establishment in Chamarajanagar Districts, Southern Karnataka. The video will explain the study's purpose, methods, and other details, as well as the participation requirements. Participants will also receive an information sheet in Kannada with a summary of the study's objectives, procedures, data collection tools, potential risks and benefits. The data collector will assure the participants that the data will be kept confidential and used only for research purposes. After giving information in the local language, the data collector will ask for written informed consent from the head of the household, the newborn's mother, father, and other members of the family. The field data collector will proceed with baseline data collection inclusive of household information such as dietary diversity, wealth index and air pollution. The team also collects specific information separately for postnatal women, newborn children and other family members who were present on the day of the visit (Table 1). The biomedical team visits on the same day or subsequent day as per the household members convience to complete anthropometric measurements and for blood collection for the specific laboratory investigation planned under the study. Follow-up visit to the house will be scheduled during child age is 3 rd , 6 th , 12 th , 18 th , 24 th, and 36 th months as detailed in the flowchart. In all visits, consent will be obtained. Role of field team Technical supervisor : The role of the technical supervisor is to obtain the details of the pregnancy registered in Chamarajanagar district from the Reproductive & Child Health (RCH) portal and to segregate the pregnancy registered from the adivasi population. He or she enters the prenatal information of women who reach 34 weeks of gestation into to Avni app an android based data collection app designed specifically for cohort data collection. Education qualification of technical supervisor will be either bachelor or master degree. Team supervisor: He/she is a senior member of the adivasi community and mainly oversee the process of data collection and plan the field activities for both data collection and biomedical team and obtain written informed consent from the household. Basic education qualification of supervisors shall be either SSLC and previous history of working with in the community for at least 10 years. Field-level data investigators/collectors : Both female and male data collectors are recruited from the adivasi community. Data collectors obtain the written consent from the participants and administer baseline and follow-up questionnaires accordingly. Education of the data collectors at least 12 th pass with previous experience in health survey or a bachelor’s degree. Biomedical team: General Nursing and Midwifery and Auxiliary Nursing and Midwifery were included in the Bio-medical team includes they are belongs to adivasi community as well to carry out anthropometric measurements, phlebotomy and to do child assessment using the Malawi Developmental assessment tool. Training Data collectors was trained on tools and the use of the mobile application in tablet as well as the administration of the survey questionnaire. For paramedical staff 3 to 4 days training and certification on Phlebotomy was be given in JSS medical college and 6 to 10 days training and certification on Anthropometric measurements was conducted Dr. Murali Krishna, Viveka Neuropsychiatric Hospital, Mysore and for every 6 months team will under go re-training and certification. The biomedical team has also undergone training on MDAT tool administration training at IIPH-Bengaluru by an expert clinical psychologist from the Sangath organization Household information : Household information is collected by interviewing the head of the household via a structured questionnaire. The team will collect socio-demographic information, wealth index, food diversity scale and air pollution exposure details from post natal paternal and maternal house. Exposure: Parental exposure to tobacco or tobacco products and alcohol: The questionnaire has been developed after reviewing earlier validated and published questionnaires from different sources including the Global Adult Tobacco Survey questionnaire, The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), WHO step questionnaire questionnaires. The alcohol and tobacco consumption patterns are assessed during baseline and follow-up interviews in terms of quantity, frequency and duration of typical use. Alcohol is recorded in quantity(volume) and tobacco use will be recorded as the number of beedi/cigarettes per day. Addressing potential biases in self-reported substance use data : Much of the information collected on substance use data is through self-report and is thus subject to potential biases. In order to address this bias, all parents will undergo a biomarker assessment (tobacco and alcohol exposure) despite their history of substance use history, however other family members will only undergo a biomarker assessment if they self-report substance use. The agreement between self-reported substance use and biomarker assessment will be carried out by comparing the reliability of these two. Avoiding blood collection from anaemic participants : To prioritize the health and well-being of study participants, sample blood collection with be deferred with Hb% of 7 gm/dl or less, till their Hb% recovers above 7 gm/dl. Participants will be with ancillary care team for assistance in receiving necessary care and treatment, as they choose. The ancillary care team will get in touch with them and assist them in receiving the necessary care and treatment. Outcome measures : Primary outcome: Child growth indicators such as stunting, wasting and underweight are considered as primary outcomes which are defined below as per the World health Organization child growth standards.(3) Stunting(HAZ): Stunting is defined as children whose height for age Z score falls below –2 standard deviation below their expected height for age. Wasting (WHZ): Wasting is defined as children whose weight for height Z score falls below -2 standard deviation below their expected weight for height. Underweight (WAZ) : underweight is defined as children whose weight for age Z score falls below -2 standard deviation below their expected weight for age. Anthropometric measurements: The weight, length/height, body circumference measures and skinfold thickness in infants are measured at baseline. These measurements will be repeated during every follow-up visits. Follow-up visits are scheduled at 3 , 6, 12, 24 and 30 th months. Parents will be provided with the key findings of the cohort assessments at every visit. Child anthropometry is performed using SECA 354 Weighing Scale and SECA 417 infant meter. Head, mid-upper arm, chest and waist circumferences is measured using SECA measurement tape. The skinfold thickness (biceps, triceps and subscapular) is measured on the left side of the body using the Holtain Callipers (Holtain, UK). Secondary outcome: A child is considered to have a global developmental delay if they fail to achieve two or more milestones/items assessed using MDAT(Malawi Developmental Assessment Tool) in any domain by the age at which 90% of the usual group of reference children would be expected to do so. (27) Malawi Developmental Assessment Tool: The tool consists of four domains which consist of 136 items in the domain of gross motor, fine motor, language and social. The scale was developed by Dr. Melissa Gladstone and has been validated in Indian settings. (28) Additional Infant measures such as gender, infant health and morbidity assessment, feeding practices and immunization details will be recorded at each time point of follow up assessment Covariates: The delivery information such as gestational age at delivery, type of delivery, place of delivery and complications during delivery are recorded. The mental health status of the mother is assessed using anxiety and depressive symptoms. Mothers’ general morbidity and details of medical treatment sought in case if any along with detailed anthropometry are recorded Depression: The Edinburgh Postnatal Depression Scale (EPDS) is used to assess the depression status of the mother. The EPDS scale has been translated into different languages and validated in India. (29) The EPDS has also been validated in South India, with a cut-off measure of ≥13. (30) As suggested in several studies, we used a cut-off measure of 13 and more to indicate postpartum depressive symptoms. (31) Depression is found to be associated with birth child growth and developmental outcomes and have greater risk for substance use.(32) Anxiety: Generalized Anxiety Disorder (GAD-7) assessment tools will be used as a screening tool to measure different types of anxiety (GAD-7). The seven-item GAD-7 use 4-point Likert-scaled items ranging from 0 (not at all) to 3 (nearly every day) The scales will be translated to Kannada and back-translated to English and pilot tested. (33) Anxiety is found to be associated with both substance use and child growth (34, 35) Anthropometric measurements: Measurement will be carried out at Baseline and at follow-up visits scheduled at 3 rd , 6 th , 12 th , 18 th , 24 th , 36 th months to asses the nutritional status of the participants. Adult anthropometry assessment: The weight is measured using Omron weighing scale, and height using the SECA 213 portable stadiometer. The study records detailed anthropometric measurements among postnatal mothers and under five children during their each follow up visit(Table 2). Other family members For individuals aged 18 years and above, information such as sociodemographic characteristics, general morbidity, substance use history, blood pressure, height and weight are measured. The blood Haemoglobin is measured among all individuals and those who self-reported the use of substance use such as alcohol and tobacco their cotinine level and GGT will be measured in blood samples. For individuals aged between 10 to below 18 years, information like sociodemographic characteristics, substance use history, height and weight are measured. Laboratory analysis and sample storage : We collect 8ml of blood from the parents and other family members who reported using substance use and only 3ml of blood from the other household members aged 18 years and above. More details on performance of test are available in Table 1. Health workers, will follow all the hygienic precautions and blood will be collected with the help of a vacutainer. Of the total 8 ml collected, 5 ml of blood is collected in a plain vacutainer for serum preparation and 3 ml in EDTA (Ethylene diamine tetra-acetic acid) tubes. All samples will be labelled with unique identification numbers and transferred to vaccine carriers with ice packs till it reaches the laboratory for testing and storage. Before moving from the house health workers will ensure clotting at the site of venipuncture. After blood Hb assessment, EDTA tube is centrifuged and 0.5ml of plasma will be dispensed in each of the three aliquots. The plain vacutainers are then centrifuged at 3500rpm for 10-15min. The serum samples of 0.5ml will be dispensed in each of the four aliquots and stored in a refrigerator for an hour and later shifted to a deep freezer (-20 C ) at the laboratory. Every month samples from the -20 C deep freeze will be shifted to a deep freezer (-80 C ) located in IIPH Bengaluru Biorepository. The consent for the storage of biological samples is included in the study consent form. The study planned to store 3 aliquots of EDTA plasma and 4 aliquots of serum from enrolled adivasi populations for planned lab investigations and future analysis. The reason for the storage of biological material is to minimize potential discomfort in case there is a need to obtain repeat samples and optimise the research costs involved, and test other research hypotheses in the future. Follow-up assessment : All enrolled participants including infants, parents and other household members are followed up periodically at the 3 rd month, 6 th month, 12 th month, 18 th month, 24 th month and 36 th month. Table 1 gives detailed measurements done at baseline and follow-up visits. List of other assessments planned: As active or passive smoking has an impact on respiratory health, the research team will conduct lung function tests using peak expiratory flow using spirometry. To understand the housing conditions, ventilation status, and sources for indoor and outdoor air pollution we have utilized a questionnaire designed for a cohort study titled “ambient and indoor air pollution in pregnancy and the risk of low birth weight and ensuing effects in infants (APPLE ) ”.(36) Lung function: The lung function peak expiratory flow will be assessed using spirometry in the adult respondents aged 18 years and more. Spirometry would be done only among the identified at-risk individuals identified using the pre-screening questionnaire. Spirometry will be carried out by the trained biomedical team. The highest outcome of three attempts at each point in time will be considered for the analysis. Air pollution : Both indoor and outdoor air pollution concerning details will be extracted using a questionnaire adapted from the APPLE cohort study.(36) Information will be collected on possible sources of air pollution such as type of fuel used, location of the stove, burning incense sticks, and frankincense sticks as part of a prayer, use of mosquito repellents, and smoking were collected. Sources of outdoor air pollution such as forest fires, in-house fire camps, the proximity of the residence to the street road, open garbage dump, and details on the burning of the garbage were collected. Ancillary care: A dedicated team is established for Ancillary care services. Any observed health-related issues ancillary care team will support the study participants by referring them to the nearest public health facility and facilitate to obtain the services. Auxiliary Nursing Midwifery will give health education on childcare and nutrition status and assist the mother in breastfeeding activities. Local facilitation shall be done by the ancillary care team to mobilize transport. All ancillary care services shall be recorded in the data base. Data quality: Data collectors will be trained on study tools administration at the field level, and consent obtaining procedures. The biomedical team has been trained in Phlebotomy at JSS medical college and certified in anthropometrics by Dr. Murali Krishna, Viveka Neuropsychiatric Hospital, Mysore before their field activities. The biomedical team has also undergone training on MDAT tool administration training at IIPH-Bengaluru by an expert clinical psychologist from the Sangath organization. To ease the process of data collection, questionnaire have been in-built with skips, jumps and validity checks. During active data collection about 5% of randomly selected households will be revisited and validated by the IIPH team and another 5% will be observed by the supervisor. Potential sources of Bias Participants may have recall bias while recalling the incidence, to minimize recall bias a recall period of one week will be considered for the dietary diversity scale. Loss to follow-up bias : A cohort member could pass away, relocate, change jobs, or opt not to participate in the study anymore. Loss to follow-up may also be related to the exposure, the outcome, or both. The reason for the loss to follow-up will be recorded by the research team. Misclassification bias : There are chances of underreporting of the exposure due to social desirability bias which will lead to misclassification of the exposure status. Through this cohort we assess the biomarker for the tobacco and alcohol consumption to overcome the misclassification bias. Data management plan : Trained field investigators will collect data on a password-protected mobile phone using Avni app from the cohort participants (see figure 4). Data storage, security, backup and archival All data will be stored in a password-protected project computer at the IPH field station and Avni repository. Back-up will be automatically done using a cloud-based backup service. Upon completion of the survey, a local copy of the master set shall be stored on the project computer. Access to the individual information of participants is restricted except for research staff. Personal information like names and participants identification number will not be revealed in any publication or presentation during conferences. Institute of Public Health, Bengaluru, and the Indian Institute of Public Health jointly own the data. After the completion of the project, all the data and project documents will be preserved for 5 years at the IIPH Bengaluru office. Subsequently, project data and files shall be deleted/destroyed securely. Statistical Analysis : Descriptive analysis will be done to summarize characteristics of cohort participants using frequency and percentage. The associations of interest for primary and secondary hypotheses will be assessed using multivariate general linear models treating child growth parameters and developmental scores as a continuous outcome with and without adjustments for potential confounders. Univariate and multivariate general linear models will be explored to determine the relationships between sociodemographic variables and the weekly quantity of standard drinks or tobacco consumed by the mother or father. To assess whether these bivariate relationships are independent of potential confounders, two further sets of analyses will be undertaken. First, possible confounding factors are included as predictor variables in a forward stepwise regression model for each outcome variable. Second, the predictor variables found to be significant are included in a logistic regression model or general linear models for each outcome variable. The risk estimate in terms of odds ratios (OR) with 95% confidence levels will be calculated to compare the risk estimate of children of mothers and fathers with substance use history. The possible interactions are also explored by including the selective variables in the model. The dose response relationship with multiple substance use and outcome indicators will be explored. Ethics: Ethical approval was obtained from the Institutional Ethical committee Indian Institute of Public Health-Bengaluru Public Health Foundation of India(IIPHHB/TRCIEC/216/2021) and from the institutional ethics committee of Institute of Public Health, Bangalore (IEC/I/ER/2022/10). We also received approval from the Technical Advisory Committee, Department of Health and Family welfare, Government of Karnataka to conduct the study. The study also received widespread community consent through Adivasi Arogya Samvaada, an annual townhall style platform gathering where representatives from most of the 148 Soliga Adivasi villages gather for a dialogue on health. Discussion The longitudinal prospective cohort studies are unique resources for further studies relating to Adivasi population undergoing epidemiological transition. This explores the feasibility of establishing Adivasi cohort in Chamarajanagar, Karnataka, South India. The study offers a comprehensive examination of parental substance use. This will help researchers identify significant risk thresholds and to better understand the consequences of parental substance use on infant development. This will be the first research of its kind in adivasi communities to monitor substance usage. Through this cohort, researchers will have a greater understanding of the psychosocial, nutritional, physiological risks associated with varied levels of substance use. The findings could be used to aid in the development of public health prevention and early intervention initiatives so that parents can make educated decisions about avoiding exposure to substance use. The findings will also show the health and nutritional profile of cohort participants and the substance use burden in the adivasi community. The results can also inform policy regarding the implementation of possible interventions to reduce the harmful effects of substance use in Adivasi populations and improve mother and child health. Declarations Availability of Data and Materials : The anonymized datasets generated and/or analysed during the current study are available in the CTRITH intranet repository (https://iphindia.org/ctrith-intranet/) or in figshare repository (https://figshare.com/) Competing interests : No competing interests were disclosed. Acknowledgments : We sincerely thank the Department of Health and Family Welfare, the Government of Karnataka, and the District Health and Family Welfare officer, Medical officers and Community health workers of Chamarajanagar District, for their guidance and support in Cohort implementation. We extend our gratitude to Zilla Budakattu Girijana Abhivruddhi Sangha (ZBGAS) and Hanuru, Yelendhur, Chamarajanagar and Gudupet Taluk Soliga Abhivruddhi Sanghas of the Adivasi people's welfare association run by members of the Soliga community at district and Taluk levels for their support in conducting the study. We are also grateful to Vivekananda Girijana Kalyana Kendra (VGKK) hospital, its doctors, and staff for ancillary care and lab support. We acknowledge the operational support provided by the department of tribal affairs and the department of forests of the Government of Karnataka. Our sincere thanks go to Dr. Murali Krishna of Viveka Neuropsychiatric Hospital, Mysore, for certifying our research team in anthropometry. We are deeply indebted to Mr. Praveen Rao, Mr. Santosh Kumar, Mr. Puneeth M, and Mr. Manjunath for facilitating administrative support and coordination. Finally, we express our utmost gratitude to all the Research Team Members of CTRITH for their unwavering support in carrying out research activities in the field. Most importantly, we extend our heartfelt appreciation to all participants for their effort to enrol and continuous participation in the ongoing cohort. Funding: This work is supported by the DBT Wellcome Trust India Alliance CRC grant [Grant No. IA/CRC/20/1/600007] awarded to Prashanth NS, Suresh Shapeti, Deepa Bhat and Upendra Bhojani. Upendra Bhojani was also supported through the DBT Wellcome Trust India Alliance fellowship awarded to him [Grant No. IA/CPH/22/1/506533]. References Heindel JJ, Balbus J, Birnbaum L, Brune-Drisse MN, Grandjean P, Gray K, et al. Developmental origins of health and disease: integrating environmental influences. 2015;156(10):3416-21. Goldstein DB. Common genetic variation and human traits. New England journal of medicine. 2009;360(17):1696. Rani M, Bonu S, Jha P, Nguyen S, Jamjoum L. Tobacco use in India: prevalence and predictors of smoking and chewing in a national cross sectional household survey. Tobacco control. 2003;12(4):e4-e. Subramanian SV, Nandy S, Kelly M, Gordon D, Davey Smith G. Patterns and distribution of tobacco consumption in India: cross sectional multilevel evidence from the 1998-9 national family health survey. Bmj. 2004;328(7443):801-6. Ruhil R. Gender and tobacco use in India. Socio-economic empowerment. 2018:224-51. National Family Health Survey - 5 Ministry of Health and Family Welfare; 2019. Mitchell P, Spooner C, Copeland J, Vimpani G, Toumbourou J, Howard J, et al. The role of families in the development, identification, prevention and treatment of illicit drug problems. 2001. Smith DK, Johnson AB, Pears KC, Fisher PA, DeGarmo DSJCm. Child maltreatment and foster care: Unpacking the effects of prenatal and postnatal parental substance use. 2007;12(2):150-60. Arria AM, Mericle AA, Meyers K, Winters KCJJoSAT. Parental substance use impairment, parenting and substance use disorder risk. 2012;43(1):114-22. Straussner SL, Fewell CHJCoip. A review of recent literature on the impact of parental substance use disorders on children and the provision of effective services. 2018;31(4):363-7. Bloch M, Althabe F, Onyamboko M, Kaseba-Sata C, Castilla EE, Freire S, et al. Tobacco use and secondhand smoke exposure during pregnancy: an investigative survey of women in 9 developing nations. Am J Public Health. 2008;98(10):1833-40. Virk A, Kalia M, Singh P, Kumar Sharma S, Goel S, Singh S, et al. Tobacco use in currently married pregnant & lactating women in India; key findings from the National Family Health Survey-5. The Lancet Regional Health - Southeast Asia. Wipfli H, Avila-Tang E, Navas-Acien A, Kim S, Onicescu G, Yuan J, et al. Secondhand smoke exposure among women and children: evidence from 31 countries. Am J Public Health. 2008;98(4):672-9. Hussong AM, Flora DB, Curran PJ, Chassin LA, Zucker RAJD, psychopathology. Defining risk heterogeneity for internalizing symptoms among children of alcoholic parents. 2008;20(1):165-93. Osborne C, Berger LMJJoFI. Parental substance abuse and child well-being: A consideration of parents' gender and coresidence. 2009;30(3):341-70. May PA, Tabachnick BG, Gossage JP, Kalberg WO, Marais A-S, Robinson LK, et al. Maternal risk factors predicting child physical characteristics and dysmorphology in fetal alcohol syndrome and partial fetal alcohol syndrome. 2011;119(1-2):18-27. Inamdar AS, Croucher RE, Chokhandre MK, Mashyakhy MH, Marinho VC. Maternal smokeless tobacco use in pregnancy and adverse health outcomes in newborns: a systematic review. Nicotine & Tobacco Research. 2014;17(9):1058-66. John RM. Crowding out effect of tobacco expenditure and its implications on household resource allocation in India. Social science & medicine. 2008;66(6):1356-67. Chen R, Clifford A, Lang L, Anstey KJJAoe. Is exposure to secondhand smoke associated with cognitive parameters of children and adolescents?-a systematic literature review. 2013;23(10):652-61. Seshadri T, Madegowda C, R Babu G, NS P. Implementation research with the Soliga indigenous community in southern India for local action on improving maternal health services. Giridhar and Nuggehalli Srinivas, Prashanth and Nuggehalli Srinivas, Prashanth, Implementation Research With the Soliga Indigenous Community in Southern India for Local Action on Improving Maternal Health Services (November 8, 2019). 2019. Srinivas PN, Seshadri T, Velho N, Babu GR, Madegowda C, Basappa YC, et al. Towards Health Equity and Transformative Action on tribal health (THETA) study to describe, explain and act on tribal health inequities in India: a health systems research study protocol. Wellcome Open Research. 2019;4. Sabu KU, Sundari Ravindran TK, Srinivas PN. Factors associated with inequality in composite index of anthropometric failure between the Paniya and kurichiya tribal communities in wayanad district of Kerala. Indian J Public Health. 2020;64(3):258-65. Philip RR, Vijayakumar K, Indu PS, Shrinivasa BM, Sreelal TP, Balaji J. Prevalence of undernutrition among tribal preschool children in Wayanad district of Kerala. International Journal of Advanced Medical and Health Research. 2015;2(1):33-8. Lipari RN, Van Horn SL. Children living with parents who have a substance use disorder. 2017. Thresia CU, Srinivas PN, Mohindra KS, Jagadeesan CK. The Health of Indigenous Populations in South Asia: A Critical Review in a Critical Time. International Journal of Health Services. 2022;52(1):61-72. Mohindra KS, Labonté R. A systematic review of population health interventions and Scheduled Tribes in India. BMC Public Health. 2010;10:438. Gladstone M, Lancaster GA, Umar E, Nyirenda M, Kayira E, van den Broek NR, et al. The Malawi Developmental Assessment Tool (MDAT): the creation, validation, and reliability of a tool to assess child development in rural African settings. PLoS Med. 2010;7(5):e1000273. Gladstone M, Lancaster GA, Umar E, Nyirenda M, Kayira E, van den Broek NR, et al. The Malawi Developmental Assessment Tool (MDAT): the creation, validation, and reliability of a tool to assess child development in rural African settings. PLoS medicine. 2010;7(5):e1000273. Patel V, Rodrigues M, DeSouza N. Gender, poverty, and postnatal depression: a study of mothers in Goa, India. American journal of Psychiatry. 2002;159(1):43-7. Fernandes MC, Srinivasan K, Stein AL, Menezes G, Sumithra R, Ramchandani PG. Assessing prenatal depression in the rural developing world: a comparison of two screening measures. Archives of women's mental health. 2011;14(3):209-16. Shivalli S, Gururaj N. Postnatal depression among rural women in South India: do socio-demographic, obstetric and pregnancy outcome have a role to play? PLoS One. 2015;10(4):e0122079. Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstetrics & Gynecology. 2005;106(5 Part 1):1071-83. De Man J, Absetz P, Sathish T, Desloge A, Haregu T, Oldenburg B, et al. Are the PHQ-9 and GAD-7 Suitable for Use in India? A Psychometric Analysis. Front Psychol. 2021;12:676398-. Pentecost R, Latendresse G, Smid M. Scoping review of the associations between perinatal substance use and perinatal depression and anxiety. Journal of Obstetric, Gynecologic & Neonatal Nursing. 2021;50(4):382-91. Foss GF, Chantal AW, Hendrickson S. Maternal depression and anxiety and infant development: A comparison of foreign‐born and native‐born mothers. Public Health Nursing. 2004;21(3):237-46. Shriyan P, Babu GR, Ravi D, Ana Y, van Schayck OC, Thankachan P, et al. Ambient and indoor air pollution in pregnancy and the risk of low birth weight and ensuing effects in infants (apple): a cohort study in Bangalore, South India. Wellcome Open Research. 2020;3:133-. Tables Tables 1 and 2 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1.xlsx Table2.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3897825","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":271008295,"identity":"1db9719c-c8bc-4d7f-816d-fb823dd6f825","order_by":0,"name":"Prafulla Shriyan","email":"","orcid":"","institution":"Indian Institute of Public Health-Bangalore, Public Health Foundation of India","correspondingAuthor":false,"prefix":"","firstName":"Prafulla","middleName":"","lastName":"Shriyan","suffix":""},{"id":271008296,"identity":"bc4a257d-81c8-4422-a1f7-c8d119bcaada","order_by":1,"name":"Yogish Channa Basappa","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA8klEQVRIiWNgGAWjYJCCA4wNDAn8zAxsDAkMzDzEa5FsJkULA0iLwQGgFgYGZsKqDY63Xzz4c4ddnvFx3mMPHu6wluFvYD728Qs+LWfOFBzmPZNcbHaYL90g8Uw6j8QBtuTZMvi03MhJOMzYdiBx22EeM4nEtsM8DAd4jJklCGg5+BOoZXMzVIs8YS3pBw7wArVsYIZqMQBqYfyAR4vkmTMMh3nbkoslDvOlAbWk8xgeZkvGG258x9sff/zZZpfH33/2mOTPNmt7uePNhxl/4NGicIDHAMqERSLQCrwRKt/A/gBNCxDgtWUUjIJRMApGHAAA25VSfahSsdcAAAAASUVORK5CYII=","orcid":"","institution":"Institute of Public Health","correspondingAuthor":true,"prefix":"","firstName":"Yogish","middleName":"Channa","lastName":"Basappa","suffix":""},{"id":271008297,"identity":"59cd4f81-d031-4d35-b04d-2fdec27b69ba","order_by":2,"name":"Giridhara R Babu","email":"","orcid":"","institution":"Department of Population Medicine, College of Medicine, QU Health, Qatar University","correspondingAuthor":false,"prefix":"","firstName":"Giridhara","middleName":"R","lastName":"Babu","suffix":""},{"id":271008298,"identity":"e7f9f323-4ee2-45fb-b931-bd528c155b62","order_by":3,"name":"Tanya Seshadri","email":"","orcid":"","institution":"Institute of Public Health","correspondingAuthor":false,"prefix":"","firstName":"Tanya","middleName":"","lastName":"Seshadri","suffix":""},{"id":271008299,"identity":"519bc132-26a7-48a2-8854-69fc53e6dd13","order_by":4,"name":"Maithili Karthik","email":"","orcid":"","institution":"Indian Institute of Public Health-Bangalore, Public Health Foundation of India","correspondingAuthor":false,"prefix":"","firstName":"Maithili","middleName":"","lastName":"Karthik","suffix":""},{"id":271008300,"identity":"750899c0-5768-46b4-9f62-e4405338c587","order_by":5,"name":"Upendra Bhojani","email":"","orcid":"","institution":"Institute of Public Health","correspondingAuthor":false,"prefix":"","firstName":"Upendra","middleName":"","lastName":"Bhojani","suffix":""},{"id":271008301,"identity":"2ec40ca4-6fff-4b4d-bd9e-e48aed21563b","order_by":6,"name":"Deepa Bhat","email":"","orcid":"","institution":"JSS Academy of Higher Education \u0026 Research","correspondingAuthor":false,"prefix":"","firstName":"Deepa","middleName":"","lastName":"Bhat","suffix":""},{"id":271008302,"identity":"54c1e76e-15c1-429c-b519-17225690e9b2","order_by":7,"name":"Suresh S Shapeti","email":"","orcid":"","institution":"Indian Institute of Public Health-Bangalore, Public Health Foundation of India","correspondingAuthor":false,"prefix":"","firstName":"Suresh","middleName":"S","lastName":"Shapeti","suffix":""},{"id":271008303,"identity":"e04a3933-c444-4160-856c-fcd4bb793323","order_by":8,"name":"Prashanth N Srinivas","email":"","orcid":"","institution":"Institute of Public Health","correspondingAuthor":false,"prefix":"","firstName":"Prashanth","middleName":"N","lastName":"Srinivas","suffix":""}],"badges":[],"createdAt":"2024-01-25 16:44:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3897825/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3897825/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":50813772,"identity":"44695cc3-2ad3-4294-822b-a793a1810bae","added_by":"auto","created_at":"2024-02-07 19:35:20","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":37230,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eDirected acyclic graph depicting the relationship between parental use of substance use and its effect on malnutrition adjusted for potential confounders.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3897825/v1/8b7c4272cc5517bf44e54365.jpg"},{"id":50813775,"identity":"62f45e13-50d1-45c4-96c1-e590d38afb42","added_by":"auto","created_at":"2024-02-07 19:35:20","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":28871,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eDirected acyclic graphs depicting the relationship between parental exposure to substance use on child developmental delay with effect modifier (maternal depression/anxiety and social support) and potential confounders.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3897825/v1/718f23b5d36e02ea5ae4b7ac.jpg"},{"id":50813773,"identity":"d04814a0-6096-4264-822c-f0ee247b4f19","added_by":"auto","created_at":"2024-02-07 19:35:20","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":68707,"visible":true,"origin":"","legend":"\u003cp\u003eA) Chamarajanagar district study sites in Karnataka state, India B) Green colour indicates forest protected area and light brown indicates the mainland of Chamarajanagar district.\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3897825/v1/d17b2084388644ae057d1a62.jpg"},{"id":50813776,"identity":"e042ec6a-0fe9-4402-9f81-857965f2c3a7","added_by":"auto","created_at":"2024-02-07 19:35:21","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":18685,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eScreenshot of Avni app showing Individual registration and kannada localisation. Copyright 2023 Avni/ Samanvaya foundation\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3897825/v1/a515176d257d665fe25ed832.jpg"},{"id":53474114,"identity":"a2bc5dbf-48a3-44ad-a2ed-5ccfcaadfdf1","added_by":"auto","created_at":"2024-03-26 12:14:37","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":763364,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3897825/v1/c173825f-e299-4dc4-87dc-7802a77c96c3.pdf"},{"id":50813774,"identity":"8ff6d17d-52a1-4245-9f3a-36db0ed3d7cb","added_by":"auto","created_at":"2024-02-07 19:35:20","extension":"xlsx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":14223,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-3897825/v1/2eccddd48147317a4f85a19f.xlsx"},{"id":50813777,"identity":"b998ef1f-e54f-456f-b5ee-04faf21baa06","added_by":"auto","created_at":"2024-02-07 19:35:21","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":16936,"visible":true,"origin":"","legend":"","description":"","filename":"Table2.docx","url":"https://assets-eu.researchsquare.com/files/rs-3897825/v1/7ca96f88764893d3b6151ab2.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"CHIGURU Adivasi Birth Cohort Study: A Protocol for Examining the Effects of Parental Substance Use on Child Development in Southern Indian Adivasi Communities","fulltext":[{"header":"Background","content":"\u003cp\u003eThe Developmental Origins of Health and Disease (DOHaD) framework suggests that exposure to poor nutrition, stress, and environmental chemicals early in life, determines the risk of short-term (physical growth and neurodevelopment) and long-term (non-communicable diseases such as coronary heart disease, hypertension or type 2 diabetes) health outcomes in children.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) The prevalence of smoking among women in India is low(0.5% in women Vs 5% in men)(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e), possibly due to the prevailing gender norms in many societies including its intersections with other social determinants (like, caste, class, location, and ethnicity) that have shaped sex-based and other differences in tobacco/substance use wherein women generally tend to have lower prevalence of substance use compared to men.(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) National Family Health Survey (NFHS-5, 2019-21) data shows around 8.9% of women (above 15 years) use tobacco and 38% of men (above 15 years), while alcohol consumption is relatively 1.3% among women and 18.8% among men.(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) Substance use throughout a person's life is influenced by a range of factors, starting at an early age. Several risk factors associated with substance use are genetic factors, stress, peer group influence, traumatic life events, such as physical abuse and neglect, low socioeconomic status, and adverse environmental factors, such as media, parents, and families. (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eClinical investigations of parents diagnosed with substance use disorders suggest that parental substance use has considerable negative effects on infant and child development. (\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) A survey done among women of nine developing nations on the use of tobacco during pregnancy shows that 9% of pregnant women in Karnataka and 34.2% of pregnant women in Orissa use various forms of tobacco products during their pregnancy.(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)Further, estimates from NFHS, 2019\u0026ndash;2020 show that the prevalence of tobacco use in pregnant women and lactating women was 2.5% and 3.2% respectively.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) Women and children are frequently exposed to indoor tobacco smoke in homes where smoking is permitted..(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) Second hand smoke exposes women to the same range of tobacco smoke toxins that active smokers do. It is likely that exposure to SHS results in issues as well, but at a lower relative risk.(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) Findings from a systematic review shows that there is an increased risk of low birth weight in nonsmoking pregnant women who are exposed to SHS. Also, it showed other adverse foetal health consequences including (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) congenital malformation and stillbirths. Children who have grown up in environments where parents or other family members consume alcohol or tobacco products serve as role models for the younger generation.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eChildren of tobacco and alcohol users experience a wide variety of adverse effects, including emotional, social, behavioural, and cognitive difficulties. (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) The study investigating the predictors on child physical characteristics shows that a mother\u0026rsquo;s nutritional status, history of alcohol use influences the physical growth characteristics of her child. (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) The supply of vital nutrients is not available to the foetus when the mother\u0026rsquo;s nutritional state is compromised by exposure to smoking and drinking; this could cause abnormalities in the foetus. As a result, a combination of tobacco and alcohol usage is linked to poor newborn outcomes, including restricted growth.(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) Tobacco use has an indirect effect on mother and child nutrition since it can divert resources from other essentials that a household may need to pay for, such food, medical care, and education. (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) Second-hand smoke exposure, which is common in family settings also affects children and has the same negative impact as active smoking. (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eIn 2014, a consortium consisting of public health researchers, Non-Governmental Organisations(NGO) and the community-based organisation (CBO) of the Soliga adivasi community in Chamarajanagar to set up a participatory action research program on maternal health supported by the WHO Alliance for Health Policy \u0026amp; Systems Research.(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) Based on this study, in 2017, the multi-method Towards Health Equity \u0026amp; Transformative Action on Tribal Health (THETA) study was taken up which examined the underlying drivers of inequities in adivasi health.(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) The current study is one of several components of a multi-component and multi-disciplinary research centre on adivasi health being established through close partnerships with the community-based adivasi collective by researchers in order to respond to the specific and neglected health problems that were reported by THETA study findings.\u003c/p\u003e \u003cp\u003eGiven the lack of laws or socio-cultural frameworks limiting indoor tobacco and its effects on children, characterising the pathways through which this affects children and mitigating these acquire public health importance.(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) Study done among adivasi communities in Kerala, India shows higher proportion of children suffer from anthropometry failure.(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) Besides the nutritional programmes there is persistent increase in malnutrition in adivasi children (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). The children of parents who use substance use are at risk of experiencing direct effect such as parental abuse or neglect and indirect effect such as insufficiency of resources(\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e) The issue of parental substance use and its contributions to physical and psychosocial development of children is even more urgent with respect to adivasi children. Furthermore, adivasi communities are often deemed hard-to-reach due to geographical, socio-cultural barriers and ethical issues that result in their under-representation in research studies, more so in longitudinal public health research. There are no peer-reviewed prospective cohort studies done among that specifically examine Adivasi communities in India or other LMICs. Since a child's health is primarily determined by the environment in which they live, adult family members' use of tobacco and alcohol may have a negative impact on their capacity to provide childcare and expose their children to more harmful environmental factors. Given the higher proportion of malnutrition among adivasi children in Chamarajanagar, this prospective study aims to investigate the effect of parental use of tobacco and alcohol on child malnutrition and early childhood developmental outcomes The study also aims to explore the interaction effect between parental tobacco and alcohol use with the child developmental indices outcomes and identifies individual/household level factors that could protect adivasi children from the harmful effects of parental substance abuse.\u003c/p\u003e"},{"header":"Methods and design","content":"\u003cp\u003e\u003cstrong\u003eAims and objectives:\u003c/strong\u003e This study aims to prospectively assess the harmful effects of parental use of tobacco and alcohol on the risk of adverse child health and developmental outcomes.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe primary objective of the study is to explore the relationship between parental use of tobacco and alcohol on child malnutrition(Figure 1) Our secondary objectives are; \u0026nbsp;Investigate the relationship between parental use of tobacco and alcohol on child developmental delay (Figure 2); Examine the interaction between parental use of alcohol and tobacco on the child outcomes and Identify individual/household level factors that could protect adivasi children from harmful effects of parental substance use.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypotheses:\u003c/strong\u003e\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eParental exposure to substance use is associated with stunting (low height for age), wasting(low weight for height), and being underweight(low weight for age).\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eParental exposure to substance use is associated with global developmental delay in children\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eStudy design:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA prospective cohort study based in Chamarajanagar district from March 2023 to October 2026. In this longitudinal cohort study, we recruit lactating/postnatal women and their partners along with other household members. This is the first large-scale adivasi birth cohort study to examine the effects of substance use among parents and other family members after delivery on infant growth and developmental outcomes till three years of age.\u0026nbsp;We are collecting both household and individual Information.\u0026nbsp;The trained team collects data on mothers’ perinatal care and services, general morbidy status, mental health status, social support and anthropometric details. The information on \u0026nbsp;household, including dietary diversity and exposure to air pollution, along with other family members substance use history and anthropometric details will be collected.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy setting\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChamarajanagar district, the southernmost district in the Karnataka, southern India (Figure 3), ranks 22\u003csup\u003end\u003c/sup\u003e among 31 districts in the Human Development Index. The district is pre-dominantly rural (83% of its population in rural areas) and thickly forested (48% of its area). The district has been divided into five \u003cem\u003etalukas\u003c/em\u003e (administrative sub-divisions: Hanur, Kollegal, Yelandur, Gundlupet, Chamarajanagar). As per the 2011 census, 11.8%(36920) of the district population ( 2011 census) is \u003cem\u003escheduled tribe\u003c/em\u003e (ST). Communities that are legally accorded the ST status are identified for provision of affirmative action in the form of education and employment benefits. Within the ST, our study identifies three communities (Soliga, Jenukuruba \u0026amp; Bettakuruba) that self-identify as \u003cem\u003eAdivasi\u003c/em\u003e (translates to firstcitizens in multiple Indian languages). Multiple Adivasi communities in Karnataka are most disadvantaged within the ST. The three Adviasi communities included in this study live in and around the legally protected forest areas in the district and have faced historical displacement for the purposes of wildlife conservation. Their historical claims over their own lands have received legal ratification only since 2006 with the legislation of the Forest Rights Act which aimed to correct historical injustices faced by them during colonial and post-colonial times. Although they historically practiced shifting cultivation, they now live in\u003cem\u003e\u0026nbsp;podus\u0026nbsp;\u003c/em\u003eor \u003cem\u003ehaadis\u003c/em\u003e\u0026nbsp; (relatively small villages often attached to a larger non-adivasi\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;village nearby and not having its own administrative identity). Their main occupation is dependent on harvest and sale of non-timber forest produce or daily wage labour in coffee estates and other non-adivasi businesses. All three adivasi communities included in this study have their own distinct language, food and cultural identity which is rapidly changing over the last few decades, often with deleterious effects on their overall adivasi identity. Access to healthcare and education is still a challenge for many Adivasi communities in India possibly due to social and historical factors and not only due to individual behavioural factors such as literacy and awareness. (25, 26) \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size estimation: Using\u003c/strong\u003e THETA study findings as a reference (cite THETA dataset), keeping 44% underweight among under-five adivasi children. The sample sizes are estimated for frequency of population keeping a 95% confidence interval and calculated sample size for 40000 adivasi population of Chamarajanagar. We obtained a sample size of 376, after adding\u0026nbsp;40% of the non-response rate, the final sample size obtained is 650.\u0026nbsp;The target subjects(newborns) and family members are recruited from the adivasi community.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNewborn baby\u003c/strong\u003e: Newborns, recruited within 90 days of birth with no major birth complications (a severe illness that required hospitalization) and parents agreed to provide written informed consent.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMother\u003c/strong\u003e:\u0026nbsp;Lactating women (not more than 90 days after delivery) aged 18 years or more, having no major medical complications, being mentally able to respond to the interviewer's questions, and agreeing to give informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFamily members including siblings:\u0026nbsp;\u003c/strong\u003eThose who residing in the same households and those who available at the time of the field visit will be included. Assent will be obtained from children aged between 7 to below 18 years, whereas for children below 7 years parental consent will be obtained, and those who are over the age of 18 would be requested for their written consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNew-born baby\u003c/strong\u003e: Twin birth, hospitalized for initial three months, and parents not willing to provide written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMother and family members\u003c/strong\u003e: Choose to withdraw their consent, not willing to participate in a cohort study, Individuals with severe mental illness or other diseases, and those who do not provide written consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants recruitment:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe potential list of adivasi pregnant women residing in Chamarajanagar district is mapped by obtaining pregnant women list from the Chamarajanagar district reproductive and child health officer, Ministry of Health and family welfare every two months and the team also verifies the existence of any pregnancy cases at the adivasi hamlets through inquiry on presence of pregnancy cases in the area during their day of visit from the \u0026nbsp;Zilla Budakattu Girijana Abhivruddhi Sangha (ZBGAS), Taluk Budakattu Girija a Abhivruddhi Sangha the indigenous people’s welfare association run by members of the Soliga people at district and Taluk. Accredited Social Health Activists (ASHA) who cater services to the selected \u0026nbsp;hamlets are also being contacted regularly by the research team to update the pregnant women list for the adivasi setting.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eParticipants are recruited by visiting the participant household in the community. Pregnant women who completed\u0026nbsp;34 weeks of gestation are being contacted by the research team to enquire about the pregnancy status, plan of delivery and expected date of delivery. Upon confirmation of delivery in any Adivasi family, the field supervisor/ data collection team will contact the health worker of the concerned area (ANM or ASHA) to plan a household visit. The head of the household, the newborn’s mother, father and other family members of the household will be approached by the research team further for consent after providing detailed information on \u0026nbsp;purpose of study. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection flow\u003c/strong\u003e: After confirming the delivery, the data collection team will contact the household members and show a study information \u0026nbsp;video in \u0026nbsp;Kannada language of Soliga dialect, not lasting more than five minutes which has a snapshot of the adivasi cohort establishment in Chamarajanagar Districts, Southern Karnataka. The video will explain the study's purpose, methods, and other details, as well as the participation requirements. Participants will also receive an information sheet in Kannada with a summary of the study's objectives, procedures, data collection tools, potential risks and benefits. The data collector will assure the participants that the data will be kept confidential and used only for research purposes. After giving information in the local language, the data collector will ask for written informed consent from the head of the household, the newborn's mother, father, and other members of the family. The field data collector will proceed with baseline data collection inclusive of household information such as dietary diversity, wealth index and air pollution. The team also collects specific information separately for postnatal women, newborn children and other family members who were present on the day of the visit (Table 1). The biomedical team visits on the same day or subsequent day as per the household members convience to complete anthropometric measurements and for blood collection for the specific laboratory investigation planned under the study. Follow-up visit to the house will be scheduled during child age is 3\u003csup\u003erd\u003c/sup\u003e , 6\u003csup\u003eth\u003c/sup\u003e, 12\u003csup\u003eth\u003c/sup\u003e, 18\u003csup\u003eth\u003c/sup\u003e, 24\u003csup\u003eth,\u003c/sup\u003e and 36\u003csup\u003eth\u003c/sup\u003e months as detailed in the flowchart. In all visits, consent will be obtained.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRole of field team\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTechnical supervisor\u003c/strong\u003e: The role of the technical supervisor is to obtain the details of the pregnancy registered in Chamarajanagar district from the Reproductive \u0026amp; Child Health (RCH) portal and to segregate the pregnancy registered from the adivasi population. He or she enters the prenatal information of women who reach 34 weeks of gestation into to Avni app an android based data collection app \u0026nbsp;designed specifically for cohort data collection. Education qualification of technical supervisor will be either bachelor or master degree.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTeam supervisor:\u003c/strong\u003e He/she is a senior member of the \u0026nbsp;adivasi community and mainly oversee the process of data collection and plan the field activities for both data collection and biomedical team \u0026nbsp;and obtain written informed consent from the household. Basic education qualification of supervisors shall be either SSLC and previous history of working with in the community for at least 10 years.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eField-level data investigators/collectors\u003c/strong\u003e: Both female and male data collectors are \u0026nbsp;recruited from the adivasi community. \u0026nbsp; Data collectors \u0026nbsp;obtain the written consent from the participants and administer baseline and follow-up \u0026nbsp;questionnaires accordingly. Education of the data collectors at\u0026nbsp;least 12\u003csup\u003eth\u003c/sup\u003e pass with previous experience in health survey or a bachelor’s degree.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBiomedical team:\u003c/strong\u003e \u0026nbsp;General Nursing and Midwifery and Auxiliary Nursing and Midwifery were included in the Bio-medical team includes they are belongs to adivasi community as well to carry out anthropometric measurements, phlebotomy and to do child assessment using the Malawi Developmental assessment tool.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTraining\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData collectors was trained on tools and the use of the mobile application in tablet as well as the administration of the survey questionnaire. For paramedical staff 3 to 4 days training and certification on Phlebotomy was be given in JSS medical college and 6 to 10 days training and certification on Anthropometric measurements was conducted\u0026nbsp;Dr. Murali Krishna, Viveka Neuropsychiatric Hospital, Mysore\u0026nbsp;and for every 6 months team will under go re-training and certification.\u0026nbsp;The biomedical team has also undergone training on MDAT tool administration training at IIPH-Bengaluru by an expert clinical psychologist from the Sangath organization\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHousehold information\u003c/strong\u003e: Household information is collected by interviewing the head of the household via a structured questionnaire. The team will collect socio-demographic information, wealth index, food diversity scale and air pollution exposure details from post natal paternal and maternal house.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExposure:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParental exposure to tobacco or tobacco products and alcohol:\u0026nbsp;\u003c/strong\u003eThe questionnaire has been developed after reviewing earlier validated and published questionnaires from different sources including the Global Adult Tobacco Survey questionnaire, The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), WHO step questionnaire questionnaires. The alcohol and tobacco consumption patterns are assessed during baseline and follow-up interviews in terms of quantity, frequency and duration of typical use. Alcohol is recorded in quantity(volume) and tobacco use will be recorded as the number of beedi/cigarettes per day.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAddressing potential biases in self-reported substance use data\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eMuch of the information collected on substance use data is through self-report and is thus subject to potential biases. \u0026nbsp;In order to address this bias, all parents will undergo a biomarker assessment (tobacco and alcohol exposure) despite their history of substance use history, however other family members will only undergo a biomarker assessment if they self-report substance use. The agreement between self-reported substance use and biomarker assessment will be carried out by comparing the reliability of these two.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvoiding blood collection from anaemic participants\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eTo prioritize the health and well-being of study participants, sample blood collection with be deferred with Hb% of 7 gm/dl or less, till their Hb% recovers above 7 gm/dl. Participants will be \u0026nbsp;with ancillary care team for assistance in receiving necessary care and treatment, as they choose. The ancillary care team will get in touch with them and assist them in receiving the necessary care and treatment.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcome measures\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePrimary outcome:\u0026nbsp;\u003c/strong\u003eChild growth indicators such as stunting, wasting and underweight are considered as primary outcomes which are defined below as per the World health Organization child growth standards.(3)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStunting(HAZ):\u003c/strong\u003e Stunting is defined as children whose height for age Z score falls below –2 standard deviation below their expected height for age.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eWasting (WHZ):\u003c/strong\u003e Wasting is defined as children whose weight for height Z score falls below -2 standard deviation below their expected weight for height.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eUnderweight (WAZ)\u003c/strong\u003e: underweight is defined as children whose weight for age Z score falls below -2 standard deviation below their expected weight for age.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAnthropometric measurements:\u003c/strong\u003e The weight, length/height, body circumference measures and skinfold thickness in infants are measured at baseline. These measurements will be repeated during every follow-up visits. Follow-up visits are scheduled at 3\u003csup\u003e,\u0026nbsp;\u003c/sup\u003e6, 12, 24 and 30\u003csup\u003eth\u003c/sup\u003e months.\u0026nbsp;Parents will be provided with the key findings of the cohort assessments at every visit.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChild anthropometry is performed using SECA 354 Weighing Scale and SECA 417 infant meter. Head, mid-upper arm, chest and waist circumferences is measured using SECA measurement tape. The skinfold thickness (biceps, triceps and subscapular) is measured on the left side of the body using the Holtain Callipers (Holtain, UK).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSecondary outcome:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA child is considered to have a global developmental delay if they fail to achieve two or more milestones/items assessed using MDAT(Malawi Developmental Assessment Tool) in any domain by the age at which 90% of the usual group of reference children would be expected to do so.\u0026nbsp;(27)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMalawi Developmental Assessment Tool:\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe tool consists of four domains which consist of 136 items in the domain of gross motor, fine motor, language and social. The scale was developed by Dr. Melissa Gladstone and has been validated in Indian settings.\u0026nbsp;(28)\u003c/p\u003e\n\u003cp\u003eAdditional Infant measures such as gender, \u0026nbsp;infant health and morbidity assessment, feeding practices and immunization details will be recorded at each time point of follow up assessment\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCovariates:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe delivery information such as gestational age at delivery, type of delivery, place of delivery and complications during delivery are recorded. The mental health status of the mother is assessed using anxiety and depressive symptoms. Mothers’ general morbidity and details of medical treatment sought in case if any along with detailed anthropometry are recorded\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDepression:\u003c/strong\u003e The Edinburgh Postnatal Depression Scale (EPDS) is used to assess the depression status of the mother. The EPDS scale has been translated into different languages and validated in India.\u0026nbsp;(29)\u0026nbsp;The EPDS has also been validated in South India, with a cut-off measure of ≥13.\u0026nbsp;(30)\u0026nbsp; As suggested in several studies, we used a cut-off measure of 13 and more to indicate postpartum depressive symptoms.\u0026nbsp;(31)\u0026nbsp;Depression \u0026nbsp;is found to be associated with birth child growth and developmental outcomes and have greater risk for substance use.(32)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAnxiety:\u003c/strong\u003e Generalized Anxiety Disorder (GAD-7) assessment tools will be used as a screening tool to measure different types of anxiety (GAD-7). The seven-item GAD-7 use 4-point Likert-scaled items ranging from 0 (not at all) to 3 (nearly every day) \u0026nbsp;The scales will be translated to Kannada and back-translated to English and pilot tested.\u0026nbsp;(33)\u0026nbsp;Anxiety is found to be associated with both substance use and child growth\u0026nbsp;(34, 35)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAnthropometric measurements:\u003c/strong\u003e\u0026nbsp; Measurement will be carried out at Baseline and at follow-up visits scheduled at 3\u003csup\u003erd\u003c/sup\u003e, 6\u003csup\u003eth\u003c/sup\u003e , 12\u003csup\u003eth\u003c/sup\u003e , 18\u003csup\u003eth\u003c/sup\u003e , 24\u003csup\u003eth\u003c/sup\u003e , 36\u003csup\u003eth\u003c/sup\u003e months to asses the nutritional status of the participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdult anthropometry assessment:\u003c/strong\u003e The weight is measured using Omron weighing scale, and height using the SECA 213 portable stadiometer. The study records detailed anthropometric measurements \u0026nbsp; among postnatal mothers \u0026nbsp;and under five children during their each follow up visit(Table 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOther family members\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFor individuals aged 18 years and above, information such as sociodemographic characteristics, general morbidity, substance use history, blood pressure, height and weight are measured. The blood Haemoglobin \u0026nbsp;is measured among all individuals and those who self-reported the use of substance use such as alcohol and tobacco their cotinine level and GGT will be measured in blood samples.\u003c/p\u003e\n\u003cp\u003eFor individuals aged between 10 to below 18 years, information like sociodemographic characteristics, substance use history, height and weight are measured.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLaboratory analysis and sample storage\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe collect \u0026nbsp;8ml of blood from the parents and other family members who reported using substance use and only 3ml of blood from the other household members aged 18 years and above. More details on performance of test are available in Table 1. Health workers, will follow all the hygienic precautions and blood will be collected with the help of a vacutainer.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOf the total 8 ml collected, 5 ml of blood is collected in a plain vacutainer for serum preparation and 3 ml in EDTA (Ethylene diamine tetra-acetic acid) tubes. All samples will be labelled with unique identification numbers and transferred to vaccine carriers with ice packs till it reaches the laboratory for testing and storage. Before moving from the house health workers will ensure clotting at the site of venipuncture. After blood Hb assessment, \u0026nbsp;EDTA tube is centrifuged and 0.5ml of plasma will be dispensed in each of the three aliquots. The plain vacutainers are then centrifuged at 3500rpm for 10-15min. The serum samples of 0.5ml will be dispensed in each of the four aliquots and stored in a refrigerator for an hour and later shifted to a deep freezer (-20\u003csup\u003eC\u003c/sup\u003e) at the laboratory. Every month samples from the -20\u003csup\u003eC\u003c/sup\u003e deep freeze will be shifted to a deep freezer (-80\u003csup\u003eC\u003c/sup\u003e) located in IIPH Bengaluru Biorepository. The consent for the storage of biological samples is included in the study consent form. The study planned to store 3 aliquots of EDTA plasma and 4 aliquots of serum from enrolled adivasi populations for planned lab investigations and future analysis. The reason for the storage of biological material is to minimize potential discomfort in case there is a need to obtain repeat samples and optimise the research costs involved, and test other research hypotheses in the future.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFollow-up assessment\u003c/strong\u003e: \u0026nbsp;All enrolled participants including infants, parents and other household members are followed up periodically at the 3\u003csup\u003erd\u003c/sup\u003e month, 6\u003csup\u003eth\u003c/sup\u003e month, 12\u003csup\u003eth\u003c/sup\u003e month, 18\u003csup\u003eth\u003c/sup\u003e month, 24\u003csup\u003eth\u003c/sup\u003e month and 36\u003csup\u003eth\u003c/sup\u003e month. Table 1 gives detailed measurements done at baseline and follow-up visits.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eList of other assessments planned:\u0026nbsp;\u003c/strong\u003eAs active or passive smoking has an impact on respiratory health, the research team will conduct lung function tests using peak expiratory flow using spirometry. \u0026nbsp;To understand the housing conditions, ventilation status, and sources for indoor and outdoor air pollution we have utilized a questionnaire designed for a cohort study titled “ambient and indoor air pollution in pregnancy and the risk of low birth weight and ensuing effects in infants (APPLE\u003cstrong\u003e)\u003c/strong\u003e”.(36)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLung function:\u003c/strong\u003e The lung function peak expiratory flow will be assessed using spirometry in the adult respondents aged 18 years and more. Spirometry would be done only among the identified at-risk individuals identified using the pre-screening questionnaire. \u0026nbsp;Spirometry will be carried out by the trained biomedical team. The highest outcome of three attempts at each point in time will be considered for the analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAir pollution\u003c/strong\u003e: \u0026nbsp;Both indoor and outdoor air pollution concerning details will be extracted using a questionnaire adapted from the APPLE cohort study.(36)\u0026nbsp;Information will be collected on possible sources of air pollution such as type of fuel used, location of the stove, burning incense sticks, and frankincense sticks as part of a prayer, use of mosquito repellents, and smoking were collected. Sources of outdoor air pollution such as forest fires, in-house fire camps, the proximity of the residence to the street road, open garbage dump, and details on the burning of the garbage were collected.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAncillary care:\u0026nbsp;\u003c/strong\u003eA dedicated team is established for Ancillary care services. Any observed health-related issues ancillary care team will support the study participants by referring them to the nearest public health facility and facilitate to obtain the services. \u0026nbsp; Auxiliary Nursing Midwifery will give health education on childcare and nutrition status and assist the mother in breastfeeding activities. Local facilitation shall be done by the ancillary care team to mobilize transport. All ancillary care services shall be recorded in the data base.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData quality:\u0026nbsp;\u003c/strong\u003eData collectors will be trained on study tools administration at the field level, and consent obtaining procedures. The biomedical team has been trained in Phlebotomy at JSS medical college and certified in anthropometrics by Dr. Murali Krishna, Viveka Neuropsychiatric Hospital, Mysore before their field activities. The biomedical team has also undergone training on MDAT tool administration training at IIPH-Bengaluru by an expert clinical psychologist from the Sangath organization.\u0026nbsp;To ease the process of data collection, questionnaire have been in-built with skips, jumps and validity checks. During active data\u0026nbsp;collection about\u0026nbsp;5% of randomly selected households will be revisited and validated\u0026nbsp;by the IIPH\u0026nbsp;team and another 5% will be observed\u0026nbsp;by the supervisor.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePotential sources of Bias\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eParticipants may have recall bias while recalling the incidence, to minimize recall bias a recall period of one week will be considered for the dietary diversity scale.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLoss to follow-up bias\u003c/strong\u003e: A cohort member could pass away, relocate, change jobs, or opt not to participate in the study anymore. Loss to follow-up may also be related to the exposure, the outcome, or both. The reason for the loss to follow-up will be recorded by the research team.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMisclassification bias\u003c/strong\u003e: There are chances of underreporting of the exposure due to social desirability bias which will lead to misclassification of the exposure status. Through this cohort we assess the biomarker for the tobacco and alcohol consumption to overcome the misclassification bias.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData management plan\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eTrained field investigators will collect data on a password-protected mobile phone using Avni app from the cohort participants (see figure 4).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData storage, security, backup and archival\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;All data will be stored in a password-protected project computer at the IPH field station and Avni repository. Back-up will be automatically done using a cloud-based backup service. Upon completion of the survey, a local copy of the master set shall be stored on the project computer. Access to the individual information of participants is restricted except for research staff. Personal information like names and participants identification number will not be revealed in any publication or presentation during conferences. Institute of Public Health, Bengaluru, and the Indian Institute of Public Health jointly own the data. After the completion of the project, all the data and project documents will be preserved for 5 years at the IIPH Bengaluru office. Subsequently, project data and files shall be deleted/destroyed securely.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDescriptive analysis will be done to summarize characteristics of cohort participants using frequency and percentage. The associations of interest for primary and secondary hypotheses will be assessed using multivariate general linear models treating child growth parameters and developmental scores as a continuous outcome with and without adjustments for potential confounders.\u003c/p\u003e\n\u003cp\u003eUnivariate and multivariate general linear models will be explored to determine the relationships between sociodemographic variables and the weekly quantity of standard drinks or tobacco consumed by the mother or father. To assess whether these bivariate relationships are independent of potential confounders, two further sets of analyses will be undertaken. First, possible confounding factors are included as predictor variables in a forward stepwise regression model for each outcome variable. Second, the predictor variables found to be significant are included in a logistic regression model or general linear models for each outcome variable.\u003c/p\u003e\n\u003cp\u003eThe risk estimate in terms of odds ratios (OR) with 95% confidence levels will be calculated to compare the risk estimate of children of mothers and fathers with substance use history. \u0026nbsp;The possible interactions are also explored by including the selective variables in the model. The dose response relationship with multiple substance use and outcome indicators will be explored.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval was obtained from the Institutional Ethical committee Indian Institute of Public Health-Bengaluru Public Health Foundation of India(IIPHHB/TRCIEC/216/2021) and \u0026nbsp;from the institutional \u0026nbsp;ethics committee of Institute of Public Health, Bangalore (IEC/I/ER/2022/10). We also received approval from the Technical Advisory Committee, Department of Health and Family welfare, Government of Karnataka to conduct the study. The study also received widespread community consent through Adivasi Arogya Samvaada, an annual townhall style platform gathering where representatives from most of the 148 Soliga Adivasi villages gather for a dialogue on health.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe longitudinal prospective cohort studies are unique resources for further studies relating to Adivasi population undergoing epidemiological transition. This explores the feasibility of establishing Adivasi cohort in Chamarajanagar, Karnataka, South India.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe study offers a comprehensive examination of parental substance use. This will help researchers identify significant risk thresholds and to better understand the consequences of parental substance use on infant development. This will be the first research of its kind in adivasi communities to monitor substance usage. Through this cohort, researchers will have a greater understanding of the psychosocial, nutritional, physiological risks associated with varied levels of substance use.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe findings could be used to aid in the development of public health prevention and early intervention initiatives so that parents can make educated decisions about avoiding exposure to substance use. The findings will also show the health and nutritional profile of cohort participants and the substance use burden in the adivasi community. \u0026nbsp;The results can also inform policy regarding the implementation of possible interventions to reduce the harmful effects of substance use in Adivasi populations and improve mother and child health.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAvailability of Data and Materials\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe anonymized datasets generated and/or analysed during the current study are available in the CTRITH intranet repository (https://iphindia.org/ctrith-intranet/) or in figshare repository (https://figshare.com/)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNo competing interests were disclosed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe sincerely thank the Department of Health and Family Welfare, the Government of Karnataka, and the District Health and Family Welfare officer, Medical officers and Community health workers of Chamarajanagar District, for their guidance and support in Cohort implementation. We extend our gratitude to Zilla Budakattu Girijana Abhivruddhi Sangha (ZBGAS) and Hanuru, Yelendhur, Chamarajanagar and Gudupet Taluk Soliga Abhivruddhi Sanghas of the Adivasi people's welfare association run by members of the Soliga community at district and Taluk levels for their support in conducting the study. We are also grateful to Vivekananda Girijana Kalyana Kendra (VGKK) hospital, its doctors, and staff for ancillary care and lab support. We acknowledge the operational support provided by the department of tribal affairs and the department of forests of the Government of Karnataka. Our sincere thanks go to Dr. Murali Krishna of Viveka Neuropsychiatric Hospital, Mysore, for certifying our research team in anthropometry. We are deeply indebted to Mr. Praveen Rao, Mr. Santosh Kumar, Mr. Puneeth M, and Mr. Manjunath for facilitating administrative support and coordination. Finally, we express our utmost gratitude to all the Research Team Members of CTRITH for their unwavering support in carrying out research activities in the field. Most importantly, we extend our heartfelt appreciation to all participants for their effort to enrol and continuous participation in the ongoing cohort.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work is supported by the DBT Wellcome Trust India Alliance CRC grant [Grant No. IA/CRC/20/1/600007] awarded to \u0026nbsp;Prashanth NS, Suresh Shapeti, Deepa Bhat and Upendra Bhojani. Upendra Bhojani was also supported through the DBT Wellcome Trust India Alliance fellowship awarded to him [Grant No. IA/CPH/22/1/506533].\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHeindel JJ, Balbus J, Birnbaum L, Brune-Drisse MN, Grandjean P, Gray K, et al. Developmental origins of health and disease: integrating environmental influences. 2015;156(10):3416-21.\u003c/li\u003e\n\u003cli\u003eGoldstein DB. Common genetic variation and human traits. New England journal of medicine. 2009;360(17):1696.\u003c/li\u003e\n\u003cli\u003eRani M, Bonu S, Jha P, Nguyen S, Jamjoum L. Tobacco use in India: prevalence and predictors of smoking and chewing in a national cross sectional household survey. Tobacco control. 2003;12(4):e4-e.\u003c/li\u003e\n\u003cli\u003eSubramanian SV, Nandy S, Kelly M, Gordon D, Davey Smith G. Patterns and distribution of tobacco consumption in India: cross sectional multilevel evidence from the 1998-9 national family health survey. Bmj. 2004;328(7443):801-6.\u003c/li\u003e\n\u003cli\u003eRuhil R. Gender and tobacco use in India. Socio-economic empowerment. 2018:224-51.\u003c/li\u003e\n\u003cli\u003eNational Family Health Survey - 5 Ministry of Health and Family Welfare; 2019.\u003c/li\u003e\n\u003cli\u003eMitchell P, Spooner C, Copeland J, Vimpani G, Toumbourou J, Howard J, et al. The role of families in the development, identification, prevention and treatment of illicit drug problems. 2001.\u003c/li\u003e\n\u003cli\u003eSmith DK, Johnson AB, Pears KC, Fisher PA, DeGarmo DSJCm. Child maltreatment and foster care: Unpacking the effects of prenatal and postnatal parental substance use. 2007;12(2):150-60.\u003c/li\u003e\n\u003cli\u003eArria AM, Mericle AA, Meyers K, Winters KCJJoSAT. Parental substance use impairment, parenting and substance use disorder risk. 2012;43(1):114-22.\u003c/li\u003e\n\u003cli\u003eStraussner SL, Fewell CHJCoip. A review of recent literature on the impact of parental substance use disorders on children and the provision of effective services. 2018;31(4):363-7.\u003c/li\u003e\n\u003cli\u003eBloch M, Althabe F, Onyamboko M, Kaseba-Sata C, Castilla EE, Freire S, et al. Tobacco use and secondhand smoke exposure during pregnancy: an investigative survey of women in 9 developing nations. Am J Public Health. 2008;98(10):1833-40.\u003c/li\u003e\n\u003cli\u003eVirk A, Kalia M, Singh P, Kumar Sharma S, Goel S, Singh S, et al. Tobacco use in currently married pregnant \u0026amp;amp; lactating women in India; key findings from the National Family Health Survey-5. The Lancet Regional Health - Southeast Asia.\u003c/li\u003e\n\u003cli\u003eWipfli H, Avila-Tang E, Navas-Acien A, Kim S, Onicescu G, Yuan J, et al. Secondhand smoke exposure among women and children: evidence from 31 countries. Am J Public Health. 2008;98(4):672-9.\u003c/li\u003e\n\u003cli\u003eHussong AM, Flora DB, Curran PJ, Chassin LA, Zucker RAJD, psychopathology. Defining risk heterogeneity for internalizing symptoms among children of alcoholic parents. 2008;20(1):165-93.\u003c/li\u003e\n\u003cli\u003eOsborne C, Berger LMJJoFI. Parental substance abuse and child well-being: A consideration of parents\u0026apos; gender and coresidence. 2009;30(3):341-70.\u003c/li\u003e\n\u003cli\u003eMay PA, Tabachnick BG, Gossage JP, Kalberg WO, Marais A-S, Robinson LK, et al. Maternal risk factors predicting child physical characteristics and dysmorphology in fetal alcohol syndrome and partial fetal alcohol syndrome. 2011;119(1-2):18-27.\u003c/li\u003e\n\u003cli\u003eInamdar AS, Croucher RE, Chokhandre MK, Mashyakhy MH, Marinho VC. Maternal smokeless tobacco use in pregnancy and adverse health outcomes in newborns: a systematic review. Nicotine \u0026amp; Tobacco Research. 2014;17(9):1058-66.\u003c/li\u003e\n\u003cli\u003eJohn RM. Crowding out effect of tobacco expenditure and its implications on household resource allocation in India. Social science \u0026amp; medicine. 2008;66(6):1356-67.\u003c/li\u003e\n\u003cli\u003eChen R, Clifford A, Lang L, Anstey KJJAoe. Is exposure to secondhand smoke associated with cognitive parameters of children and adolescents?-a systematic literature review. 2013;23(10):652-61.\u003c/li\u003e\n\u003cli\u003eSeshadri T, Madegowda C, R Babu G, NS P. Implementation research with the Soliga indigenous community in southern India for local action on improving maternal health services. Giridhar and Nuggehalli Srinivas, Prashanth and Nuggehalli Srinivas, Prashanth, Implementation Research With the Soliga Indigenous Community in Southern India for Local Action on Improving Maternal Health Services (November 8, 2019). 2019.\u003c/li\u003e\n\u003cli\u003eSrinivas PN, Seshadri T, Velho N, Babu GR, Madegowda C, Basappa YC, et al. Towards Health Equity and Transformative Action on tribal health (THETA) study to describe, explain and act on tribal health inequities in India: a health systems research study protocol. Wellcome Open Research. 2019;4.\u003c/li\u003e\n\u003cli\u003eSabu KU, Sundari Ravindran TK, Srinivas PN. Factors associated with inequality in composite index of anthropometric failure between the Paniya and kurichiya tribal communities in wayanad district of Kerala. Indian J Public Health. 2020;64(3):258-65.\u003c/li\u003e\n\u003cli\u003ePhilip RR, Vijayakumar K, Indu PS, Shrinivasa BM, Sreelal TP, Balaji J. Prevalence of undernutrition among tribal preschool children in Wayanad district of Kerala. International Journal of Advanced Medical and Health Research. 2015;2(1):33-8.\u003c/li\u003e\n\u003cli\u003eLipari RN, Van Horn SL. Children living with parents who have a substance use disorder. 2017.\u003c/li\u003e\n\u003cli\u003eThresia CU, Srinivas PN, Mohindra KS, Jagadeesan CK. The Health of Indigenous Populations in South Asia: A Critical Review in a Critical Time. International Journal of Health Services. 2022;52(1):61-72.\u003c/li\u003e\n\u003cli\u003eMohindra KS, Labont\u0026eacute; R. A systematic review of population health interventions and Scheduled Tribes in India. BMC Public Health. 2010;10:438.\u003c/li\u003e\n\u003cli\u003eGladstone M, Lancaster GA, Umar E, Nyirenda M, Kayira E, van den Broek NR, et al. The Malawi Developmental Assessment Tool (MDAT): the creation, validation, and reliability of a tool to assess child development in rural African settings. PLoS Med. 2010;7(5):e1000273.\u003c/li\u003e\n\u003cli\u003eGladstone M, Lancaster GA, Umar E, Nyirenda M, Kayira E, van den Broek NR, et al. The Malawi Developmental Assessment Tool (MDAT): the creation, validation, and reliability of a tool to assess child development in rural African settings. PLoS medicine. 2010;7(5):e1000273.\u003c/li\u003e\n\u003cli\u003ePatel V, Rodrigues M, DeSouza N. Gender, poverty, and postnatal depression: a study of mothers in Goa, India. American journal of Psychiatry. 2002;159(1):43-7.\u003c/li\u003e\n\u003cli\u003eFernandes MC, Srinivasan K, Stein AL, Menezes G, Sumithra R, Ramchandani PG. Assessing prenatal depression in the rural developing world: a comparison of two screening measures. Archives of women\u0026apos;s mental health. 2011;14(3):209-16.\u003c/li\u003e\n\u003cli\u003eShivalli S, Gururaj N. Postnatal depression among rural women in South India: do socio-demographic, obstetric and pregnancy outcome have a role to play? PLoS One. 2015;10(4):e0122079.\u003c/li\u003e\n\u003cli\u003eGavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstetrics \u0026amp; Gynecology. 2005;106(5 Part 1):1071-83.\u003c/li\u003e\n\u003cli\u003eDe Man J, Absetz P, Sathish T, Desloge A, Haregu T, Oldenburg B, et al. Are the PHQ-9 and GAD-7 Suitable for Use in India? A Psychometric Analysis. Front Psychol. 2021;12:676398-.\u003c/li\u003e\n\u003cli\u003ePentecost R, Latendresse G, Smid M. Scoping review of the associations between perinatal substance use and perinatal depression and anxiety. Journal of Obstetric, Gynecologic \u0026amp; Neonatal Nursing. 2021;50(4):382-91.\u003c/li\u003e\n\u003cli\u003eFoss GF, Chantal AW, Hendrickson S. Maternal depression and anxiety and infant development: A comparison of foreign‐born and native‐born mothers. Public Health Nursing. 2004;21(3):237-46.\u003c/li\u003e\n\u003cli\u003eShriyan P, Babu GR, Ravi D, Ana Y, van Schayck OC, Thankachan P, et al. Ambient and indoor air pollution in pregnancy and the risk of low birth weight and ensuing effects in infants (apple): a cohort study in Bangalore, South India. Wellcome Open Research. 2020;3:133-.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 and 2 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Adivasi, cohort, parental substance use, child development, tribal health","lastPublishedDoi":"10.21203/rs.3.rs-3897825/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3897825/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Children of parents who use tobacco and alcohol are at increased risk for a variety of adverse outcomes, including emotional, social, behavioral, and cognitive problems. Parental smoking and alcohol use can also lead to nutrient deficiencies in children, as well as poor birth outcomes such as restricted growth. Among adivasi communities, disproportionately higher malnutrition, and increasing substance use could be contributing to persistent and inter-generational developmental disadvantages. However, there is limited research on the long-term health implications of parental substance use on children after birth. The proposed study will examine the effects of parental substance use on child growth and developmental outcomes in adivasi communities in southern Karnataka.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThe research design involves a longitudinal cohort study, in which lactating/postnatal women and their partners along with other household members are recruited. This is the first large-scale adivasi birth cohort study to examine the effects of substance use among parents and other family members after delivery on infant growth and developmental indices. Information on the household socio-demographics, wealth index, diet, \u0026nbsp;delivery information, depression, social support, morbidity status, substance use details, and child development with anthropometric details in baseline and follow-up visits shall be recorded. The study targets to recruit a sample size of 650 newborns and family members. The primary outcome is child growth parameters whereas the secondary outcome is early childhood development in terms of gross motor, fine motor, language, and social domain. The total duration of the study is five years (2021-2026).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e: The study offers a comprehensive examination of parental substance use and its effect on child development in an adivasi community in south India. This will help researchers identify significant risk thresholds and better understand the consequences of parental substance use on infant development utilizing the prospective adivasi family cohort. The study will also address the long-term under-representation and neglect of such studies among adivasi populations and enable a long-term research engagement with the community. The study could inform policy and practice related to addressing substance use disorders and their effects on children. The public health implications include prioritizing the issues of parental substance use, and identification of early interventions to prevent adverse health outcomes in children.\u003c/p\u003e","manuscriptTitle":"CHIGURU Adivasi Birth Cohort Study: A Protocol for Examining the Effects of Parental Substance Use on Child Development in Southern Indian Adivasi Communities","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-07 19:35:15","doi":"10.21203/rs.3.rs-3897825/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d6af372c-e409-4b7c-a61a-ec2096529e10","owner":[],"postedDate":"February 7th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-03-26T12:06:30+00:00","versionOfRecord":[],"versionCreatedAt":"2024-02-07 19:35:15","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3897825","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3897825","identity":"rs-3897825","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}