Integrated life skill training and executive function strategies in children with autism spectrum disorder in Qatar: study protocol for a randomized controlled trial

Integrated life skill training and executive function strategies in children with autism spectrum disorder in Qatar: study protocol for a randomized controlled trial | 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 Research Article Integrated life skill training and executive function strategies in children with autism spectrum disorder in Qatar: study protocol for a randomized controlled trial Bara Yousef, Dr. Naresh Bhaskar Raj, Dr. Nadiah Wan-Arfah, Brightlin Nithis Dhas, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3319632/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 : Executive function (EF) impairment is common in children with autism spectrum disorder (ASD). EF strategies are considered effective in improving therapeutic outcomes of children with ASD. This study primarily aims to explore whether integrating EF strategies combined with regular occupational therapy intervention is more effective in improving daily life skills (DLS) and sensory integration/processing (SI/SP) skillsthan regular occupational therapy alone in children with ASD and secondarily aimsto assess treatment outcomes on improving visual motor integration (VMI) skills. Methods: A total of 92 children with ASD will be recruited and following baseline assessments randomly assigned to the treatment group (45-min once weekly individual occupational therapy plus EF strategies) and control group (45-min once weekly individual therapy sessions alone). Discussion: All children will be evaluated systematically by assessing SI/SP, DLS, and VMI, skills at baseline, 7 weeks, and 14 weeks of treatment. Data will be analyzed using analysis of covariance and t-test. This single-blind randomized controlled trial will provide empirical evidence for the effectiveness of EF strategies when combined with regular occupational therapy programs. Based on trial results, EF strategies could be recommended in multidisciplinary programs for children with ASD. Clinical trial registration : This trial has been registered on the clinicaltrail.gov for registry, protocol ID: MRC-01-22-509 ClinicalTrials.gov Identifier: NCT05829577, registered April 25, 2023. Physical Medicine & Rehab autism spectrum disorder executive function strategies daily life skills sensory integration/processing visual motor integration occupational therapy effectiveness Figures Figure 1 1. Background ASD is a neurodevelopmental disorder characterized by socio-communicative impairments and restricted, repetitive patterns of behaviors and interests that negatively impact children’s development (DSM & American Psychiatric Association Publishing, 2013; Qiu & Yuan, 2019 ). The prevalence of autism spectrum disorder (ASD) is increasing globally with an estimate median prevalence of 65/10,000 (Zeidan et al., 2022 ). The Centre for Disease Control and Prevention reported that approximately 1 in 36 children 8 years of age in the USA was estimated to have ASD (Maenner et al., 2023 ). Children with ASD may have other comorbidities, including epilepsy, sleep disorders, gastrointestinal disorders, toileting problems, behavioral disorders, learning disorders, attention deficit hyperactivity disorder, intellectual disability, anxiety, and depression, (Bausela-Herreras et al., 2019 ; Maenner et al., 2020 ). Deficits in executive functions (EF), including working memory, inhibitory control, self-regulation, and cognitive flexibility, which involve planning and problem-solving, were also reported among children with ASD. These children require treatment programs that involve a multidisciplinary team targeting functional and life domains. Impairments in EF skills will subsequently impact participation in these domains and affect the quality of life and participation (Jaekel et al., 2016 ;). Therefore, developing effective intervention strategies that incorporate EF skills is crucial. To achieve this, we need to understand the nature of EF impairment in children with ASD and the reported treatment recommendation that aligns with the OT program. 1.1 EF impairment in children with ASD More than half of children with ASD have impairments in EF skills, despite their intelligence quotient (IQ) being within the normal range or higher (Lai et al., 2017 ; Pugliese et al., 2016 ). Compared to typically developing children, children with ASD were reported to have impairments in all EF domains such as inhibitory control, self-regulation, planning, and problem-solving (Jones et al., 2018 ; Zimmerman et al., 2017 ). Impairment in EF skills could affect core ASD symptoms such as stereotypic and repetitive behaviors, thereby influencing the ASD phenotype (Demetriou et al., 2018 ; Hill, 2004 ). For example, inhibitory control and self-regulation were found to be highly correlated with the presence of stereotypic and repetitive behaviors in children with ASD. While other EF skills such as working memory, shifting, and inhibition are suggested to be associated with other areas of core ASD symptoms such as social communication (Kaushanskaya et al., 2017 ; Leung et al., 2016 ). Consequently, children with ASD perform poorly on verbal working memory tasks than those with typical language development (Kimhi et al., 2014 ; Van Eylen et al., 2015 ). 1.2 EF training for children with ASD Over the last decade, several studies have investigated the effect of EF training on children with ASD. The majority of the studies reported improvement in core executive skills like problem-solving abilities, as measured via direct assessments (Stichter et al., 2012 ). Improvements in planning and organization skills were reported in another study using the Unstuck and On Target intervention that targets flexibility, planning, and problem-solving when compared with the social skill (SS) intervention (Kenworthy et al., 2014 ). Self-regulation, a key EF skill in children with ASD, has also been discussed in some studies. Following the implementation of EF training and social competence intervention, improvements were observed in participants’ ability to regulate behavior and utilize cognitive resources (Scarpa & Reyes, 2011 ; Thompson & Johnston, 2013 ). Likewise, only a few studies have investigated the outcomes in social communication and language skills following the EF training and suggested that EF interventions are associated with improvements in social communication skills in children with ASD and better outcomes in language skills (Friedman & Sterling, 2019 ). Improvements in social communication skills have also been reported in 5–7-year-old children with ASD following the use of EF strategies in schools, and positive results were observed in classroom engagement, social interaction, adaptive communication, and social skills (Morgan et al., 2018 ). Computerized EF training can also be a useful technique to improve EF skills among children with ASD of different ages when implemented by teachers in regular classrooms (de Bruin et al., 2013 ). However, computerized EF training was shown to be more beneficial for older children, aged 8–12 years than those aged 4–5 years (de Bruin et al., 2013 ). Conversely, non-computerized training has shown better results because it involves more in-person, trainer–trainee interactions than computerized cognitive training (Diamond & Ling, 2019 ) Most of the published studies on EF training have examined its effectiveness in improving social communication skills when implemented as a stand-alone strategy or in combination with social communication training (Cascia & Barr, 2017 ), No study had explored the outcomes of EF training in improving daily life skills (DLS) or sensory integration/processing (SI/SP) skills. 1.3 Aim of the current study This study aimed to (1) investigate the effects of DLS and SI/SP training combined with EF strategies and DLS and SI/SP training alone on the improvement of self-care, and SI skills in children with ASD; (2) evaluate the effects of DLS and SI/SP training on the improvement of self-care and SI skills in children with ASD; and (3) examine the effect of DLS and SI training. We hypothesize that executive function training combined with DLS and SI/SP training is more effective in improving self-care and SI skills than only DLS and SI/SP training alone in children with ASD. 2. Method/Design 2.1 Study design This study protocol was designed in line with other previous protocols and studies (Kenworthy et al., 2014 ; Morgan et al., 2018 ; Stackhouse et al., 2023 ) that demonstrated that EF training for children with ASD can be effective and that SI/SP training and DLS training for children with ASD are also effective; however, our study goes a step further forward by combining EF training with SI/SP and DLS training. The current study protocol is a single-blinded, randomized control trial (RCT) with two arms: OT + EF (treatment) versus OT (control). The duration of intervention and length of each session will be the same for both groups in a 45-min session/week for 13 weeks. The two groups will be compared at baseline and 7 and 14 weeks of treatment (Fig. 1 ). This study was approved by the XXXX (XXXX) and the XXXX (XXXX). Informed consent will be obtained from the parents of participants. 2.2 Participants Children with a confirmed diagnosis of ASD referred to the XXXX will be approached for study participation. ASD diagnosis will be confirmed by a multidisciplinary team at the XXXX. The diagnostic team included consultant neurodevelopmental pediatricians, occupational therapists, speech therapists, and psychologists. All of them specialized in ASD diagnosis. Children will be included if they have a confirmed diagnosis of ASD, have a referral to the Autism Program, and are between ages 3 and 5 years. All eligible children irrespective of their native languages will be included. Exclusion criteria include children with severe impairments in learning and linguistic acquisition skills with a score of 4 on any item of Barrier Assessment on the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) and whose parents are unwilling to give consent. Children who do not complete 13 intervention sessions and those who underwent other interventions that may affect the study results will be considered drop-outs and hence excluded from the analysis. Moreover, those who did not complete all outcome measures will be excluded from the analysis. Study screening will be performed by the Primary Investigator (PI) after the parents have given their written informed consent. Parents will be asked to come for another session during which the PI will perform screening based on the eligibility criteria. All eligible patients who will sign the consent form will be enrolled in the study. The PI will discuss the enrolment for study and confirm for parents on the same day of screening after the completion of the required assessment. 2.3 Sample size determination A priori power analysis was conducted using G*Power 3.1.9.6 considering an effect size of 80 and a 5% margin of error based on previous studies (Kenworthy et al., 2014 ; Stackhouse et al., 2023 ). The results of the power analysis indicated that 67 participants are required to detect group differences at the β = .80 level and a 5% margin of error. A total of 92 children will be enrolled to account for possible attrition. 2.4 Randomization and blinding Participants will be randomized (1:1) and assigned to the treatment or the control group using a computer-generated sequence. Baseline and outcome assessments will be performed by independent evaluators blinded to the study groups. The evaluators are trained in conducting the study assessments 2.6 Ethical considerations Ethical approval for the study was obtained from XXXX and institutional review board XXXX. Parents of all children referred to the Autism Program will be informed about the research and those who agree to participate will be screened by the PI based on the eligibility criteria. Potential participants will be given the choice of whether to participate in the study, and additional time will be provided if required to make the decision. Informed consent will be taken from those parents whose children were eligible for the study. The participant names will be replaced by a code number in the dataset for anonymity. All collected data will be saved in a password-protected folder, only on the XXXX computer and network. Only the authors will have access to the data. Parents of children who are admitted to the Autism Program will be asked whether they agree to join the study or not; if they agree, they will be asked to sign the consent form which will be given to them by the admin nurse, in the presence of the PI. There are no major risks associated with this study; however, children may get upset while performing the tasks. 2.7 Study measures An overview of all outcome measures from that will be used in this study is shown in Table 1 . Table 1 Study schedule for recruitment, interventions, and outcome measurements. Study period Enrolment Allocation Post-allocation Timepoint (week) −1 0 7 14 Enrolment Informed consent X Eligibility (screening) X Randomization X Allocation X Assessment VB-MAPP X X X X SSP2 X X X WeeFIM X X X VMI X X X 2.7.1 Screening measures The verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) will be used to determine eligibility. VB-MAPP has five dimensions: Milestones Assessment, Barriers Assessment, which was used for inclusion criteria; Transition Assessment, Task Analysis Skills Tracking; and Placement and Individualized Education Program Goals. VB-MAPP barrier assessment uses a 5-point scale (0–4), with 0 being the lowest and 4 being the highest. VB-MAPP is the most widely used instrument for curriculum development and treatment planning in the field of ASD training. Moreover, it also has good psychometric properties and is a reliable and valid measure (Padilla, 2020 ; Padilla & Akers, 2021 ). 2.7.2 Outcome measures 2.7.2.1 Primary outcome measure VB-MAPP Transition Assessment will also be used for measuring improvements in self-help skills. VB-MAPP transition assessment uses a 4-point scale (1–4), with 1 being the lowest and 4 being the highest. VB-MAPP transition assessment includes good psychometric properties and is a reliable and valid measure (Padilla, 2020 ; Padilla & Akers, 2021 ). WeeFIM will be used to measure improvements in self-care and social cognition skills. It consists of 18 items with three domains: self-care, mobility, and social cognition. Each item uses a seven-level method of 1–7 points. In this study, only self-care and social cognition domains were used. WeeFIM is shown to demonstrate high internal consistency responsive to change and good convergent validity (Ottenbacher et al., 2000 ). Short Sensory Profile™ 2 (SSP2) will be used to measure improvement in sensory processing. SSP2 comprises a 34-item caregiver questionnaire, and all the items are scored on a 5-point Likert scale (ranging from always to never). A lower score indicates the presence of more atypical sensory responses. SSP2 has a total score and seven subsection scores, which can be used to classify children’s sensory impairments into four categories: seeking, avoidance, sensitivity, and registration. SSP2 is one of the most commonly used measures of sensory features in children with ASD, and responsiveness to change, concurrent validity, and reliability appear satisfactory (Hand et al., 2017 ; Lajonchere et al., 2012 ; Tomchek et al., 2014 ) 2.7.2.2 Secondary outcome measure The visual motor integration (VMI) test will be used to measure changes in visual motor integration, contains 30 items, and uses a binomial scale with 0 denoting the absence and 1 denoting the presence of skill. VMI is a widely used visual motor assessment tool because of its extensive and well-documented psychometric properties. Its inter-rater reliability ranges from 0.92–0.98, and it has a test–retest reliability correlation of 0.92 for a 2-week interval. Based on the norming studies (Bart et al., 2007 ), VMI is responsive to change and does not show cultural bias (Beery, 2010 ; Case-Smith, 2000 ; Green et al., 2016 ). 2.8 Intervention A 13-week occupational therapy training program will be conducted. One session will run each week to form 13 sessions over 13 consecutive weeks. The duration of each session will be 45 min. The program consisted of EF strategies and training, DLS training, and SI/SP training. EF strategies and training will be conducted by a PI and a trained therapist only for the treatment group. EF strategies will be implemented during the DLS and SI training and will target the following areas: using a monitoring system for each child, improving the sense of time, externalizing important information, externalizing motivation, and personalizing the command and praise along with direct intervention at the point of performance. Children in the treatment and control groups will receive DLS training and SI/SP training, which focused on training children on grooming, feeding, dressing and undressing, toileting, community reintegration tasks aligned with the facilitation of fine motor skills for children, and using several techniques for activities of daily living training, including prompting, shaping, forward and backward chaining, and modeling. The training was based on the level of independency identified by the WeeFIM score. Therapies such as deep pressure, brushing, weighted vests, and swinging will be implemented. Individually tailored treatment activities included the use of a carpeted scooter board while in a prone position to pull oneself up a ramp and then turning the scooter board around to ride down the ramp and land in a cushioned area of mats and pillows covered with various textures (Schaaf et al., 2018 ; Schoen et al., 2019 ). The intervention contextualized in play with the active involvement of the child will be conducted in a large gym equipped with mats, a variety of suspended swings, large balls, a climbing wall, carpeted barrels, large inner tubes, and foam blocks with opportunities for active, guided, sensory-motor play (Cham et al., 2021 ; Wuang et al., 2020 ). The control group will receive regular occupational therapy for the same duration and intensity. 2.9 Statistical considerations and data analysis The primary outcome measures used in this study are VB-MAPP, SP2, and WeeFIM. The secondary outcome is VMI. Changes in the pre-test and post-test scores (Standard Score, Percentile Rank, and P-value) will be compared between the intervention and control groups using a linear-mixed regression model and the analysis of covariance (ANCOVA) using the repeated-measures analysis of variance, with comparing baseline scores with re-assessment and post-treatment scores. The heterogeneity of children between the treatment and control groups based on screening measures will be assessed and reported using the t-test. Associations between two or more categorical datasets/variables (sex, parent level of education, etc.) will be assessed using the chi-square test. The 95% significance level will be used when performing statistical tests. Since the hypothesis is unidirectional, we will use one-tailed test p-values. We will use the statistical package for social sciences (SPSS-28) to analyze our data (Wolach & McHale, 2008 ). 3. Discussion Children with ASD present impairment with several EF skills with different levels of impairment. EF strategies and training are important components of the treatment program for children with ASD and can be combined with other training programs such as occupational therapy, which is the target training on SI/SP and DLS. The information on the preparation period of this study can be of great interest to other studies for designing and performing relevant studies. The findings of this study might impact the following aspects: if the treatments have the same efficacy, and if there is a difference between the two interventions in improving SI/SP and DLS in children with ASD. This might give rise to further research; moreover, investigations on other factors, such as the severity of ASD, SI/SP, and DLS training techniques and parent’s compliance with treatment and educational level might be conducted in the future. The outcome of the study will also contribute to strengthening the limited existing evidence on the efficacy of EF enhancement strategies for children with ASD. If determined effective, the program can also be integrated into the service delivery mode of an occupational therapy program in different healthcare centers for children with ASD in Qatar. Declarations Ethics approval and consent to participate : This study was approved by the Institutional Review Board of Hamad Medical Corporation (HMC) (IRB-HMC-2021-011) and the Medical Research Center (MRC-01-22-509). Consent for publication : NA Availability of data and materials : The data that support the findings of this study are available on request from the corresponding author and [or first author] with reasonable restrictions. The data are not publicly available due to [laws and regulation of author organization]. Competing interests : The authors declare that they have no competing interests. Funding : None Authors' contributions : Bara Mohammed Yousef(Author contribution on : Methodology, Investigation Conceptualization,Data curation, role/writing -orginal draft Naresh Bhaskar Raj (Author contribution on :,Writing - review & editing, Methodology) Nadiah Wan-Arfah (Author contribution on :,Writing - review & editing, Methodology) Brightlin Nithis Dhas (Author contribution on :,Writing - review & editing, Methodology) Florence Vargas Rosal (Author contribution on : review & editing, investigation and resources ) Ahmad Mohammad Mansour (Author contribution on : review & editing , investigation and resources ) Rana Moufeed Ajouly (Author contribution on : review & editing , investigation and resources ) Samah ahmad Abd Alhadi (Author contribution on : review & editing , investigation and resources ) Marnel Morada Dizon (Author contribution on : review & editing , investigation and resources ) Nadhira Sboui (Author contribution on : review & editing ,investigation and resources ) Acknowledgements : References Bart, O., Hajami, D., & Bar-Haim, Y. 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Revue Canadienne d’Ergotherapie, 90, 25–33. https://doi.org/10.1177/00084174221129941 . Stichter, J. P., O'Connor, K. V., Herzog, M. J., Lierheimer, K., & McGhee, S. D. (2012). Social competence intervention for elementary students with Aspergers syndrome and high functioning autism. Journal of Autism and Developmental Disorders, 42, 354–366. https://doi.org/10.1007/s10803-011-1249-2 . Thompson, R. M., & Johnston, S. (2013). Use of social stories to improve self-regulation in children with autism spectrum disorders. Physical and Occupational Therapy in Pediatrics, 33, 271–284. https://doi.org/10.3109/01942638.2013.768322 . Tomchek, S. D., Huebner, R. A., & Dunn, W. (2014). Patterns of sensory processing in children with an autism spectrum disorder. Research in Autism Spectrum Disorders, 8, 1214–1224. https://doi.org/https://doi.org/10.1016/j.rasd.2014.06.006 . Van Eylen, L., Boets, B., Steyaert, J., Wagemans, J., & Noens, I. (2015). Executive functioning in autism spectrum disorders: influence of task and sample characteristics and relation to symptom severity. European Child and Adolescent Psychiatry, 24, 1399–1417. https://doi.org/10.1007/s00787-015-0689-1 . Wolach, A. H., & McHale, M. A. (2008). WolStat: a new statistics package for the behavioral and social sciences. Behavior Research Methods, 40, 94–101. https://doi.org/10.3758/brm.40.1.94 . Wuang, Y. P., Huang, C. L., & Tsai, H. Y. (2020). Sensory integration and perceptual-motor profiles in school-aged children with autistic spectrum disorder. Neuropsychiatric Disease and Treatment, 16, 1661–1673. https://doi.org/10.2147/ndt.S253337 . Zeidan, J., Fombonne, E., Scorah, J., Ibrahim, A., Durkin, M. S., Saxena, S., Yusuf, A., Shih, A., & Elsabbagh, M. (2022). Global prevalence of autism: A systematic review update. Autism Research: Official Journal of the International Society for Autism Research, 15, 778–790. https://doi.org/10.1002/aur.2696 . Zimmerman, D., Ownsworth, T., O'Donovan, A., Roberts, J., & Gullo, M. J. (2017). Associations between executive functions and mental health outcomes for adults with autism spectrum disorder. Psychiatry Research, 253, 360–363. https://doi.org/10.1016/j.psychres.2017.04.023 . 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-3319632","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":230508311,"identity":"83e8214d-cc7a-4eea-93b0-6bde778a433f","order_by":0,"name":"Bara Yousef","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4klEQVRIiWNgGAWjYBACAwglIcfP3nwAxJAhUkuChbFkz7EEkBYeYrVUJG64kQNmE9Zizn724YePPyQSZzbkfH51o8aCh4H98NEN+LRY9qQbS85IkDDuZzi7zTrnGNBhPGlpN/A67EAagzRPgoTszMbebcY5bEAtEjxm+LWcf8b8G6iFccNhnmfGOf+I0XIjjQ1ki+KGYzzMj3PbiNBiOeMZm+WMNAlgILOZMef2SfCwEfKLOX8a840PNnVy/PKPH3/O+QZksB8+hlcLMmCTAJPEKgcB5g+kqB4Fo2AUjIKRAwD8q0XFVoI0wwAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0009-0004-6878-7679","institution":"Hamad Medical Corporation","correspondingAuthor":true,"prefix":"","firstName":"Bara","middleName":"","lastName":"Yousef","suffix":""},{"id":230508312,"identity":"b761df48-f7f9-48b7-a186-24eb77256921","order_by":1,"name":"Dr. Naresh Bhaskar Raj","email":"","orcid":"","institution":"Universiti Sultan Zainal Abidin","correspondingAuthor":false,"prefix":"Dr.","firstName":"Naresh","middleName":"Bhaskar","lastName":"Raj","suffix":""},{"id":230508313,"identity":"0e0c8a3c-fff5-4cef-ba7b-3a5ba96278ba","order_by":2,"name":"Dr. Nadiah Wan-Arfah","email":"","orcid":"","institution":"Universiti Sultan Zainal Abidin","correspondingAuthor":false,"prefix":"Dr.","firstName":"Nadiah","middleName":"","lastName":"Wan-Arfah","suffix":""},{"id":230508314,"identity":"bbcf6e93-b2fa-41ee-ae43-04525a535b60","order_by":3,"name":"Brightlin Nithis Dhas","email":"","orcid":"","institution":"Hamad Medical Corporation","correspondingAuthor":false,"prefix":"","firstName":"Brightlin","middleName":"Nithis","lastName":"Dhas","suffix":""},{"id":230508315,"identity":"ee642a1f-3cca-4610-9cd3-f55d77c0e86f","order_by":4,"name":"Florence Vargas Rosal","email":"","orcid":"","institution":"Hamad Medical Corporation","correspondingAuthor":false,"prefix":"","firstName":"Florence","middleName":"Vargas","lastName":"Rosal","suffix":""},{"id":230508316,"identity":"de8de9df-1698-4f23-8282-a66c4732adb8","order_by":5,"name":"Ahmad Mohammad Mansour","email":"","orcid":"","institution":"Hamad Medical Corporation","correspondingAuthor":false,"prefix":"","firstName":"Ahmad","middleName":"Mohammad","lastName":"Mansour","suffix":""},{"id":230508317,"identity":"e2af29fe-3726-4579-b437-d0ae31017a91","order_by":6,"name":"Samah ahmad Abd Alhadi","email":"","orcid":"","institution":"Hamad Medical Corporation","correspondingAuthor":false,"prefix":"","firstName":"Samah","middleName":"ahmad Abd","lastName":"Alhadi","suffix":""},{"id":230508318,"identity":"c687b39f-01fe-4a20-863f-95dbc7045399","order_by":7,"name":"Marnel Morada Dizon","email":"","orcid":"","institution":"Hamad Medical 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11:33:32","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":true,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":true,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false,"coiExplicitlySet":false},"doi":"10.21203/rs.3.rs-3319632/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3319632/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":42715580,"identity":"fbe28bd8-386e-475c-863b-5240e39e943f","added_by":"auto","created_at":"2023-09-06 13:58:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":40020,"visible":true,"origin":"","legend":"\u003cp\u003eStudy schedule for recruitment, interventions, and outcome measurements\u003c/p\u003e","description":"","filename":"Fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-3319632/v1/48bdd88ca65f3d303fa9d39c.png"},{"id":42715584,"identity":"7a72e372-6c4d-42a8-9a44-a36866d825b4","added_by":"auto","created_at":"2023-09-06 13:58:40","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":401394,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3319632/v1/242db75e-e06a-4126-8bce-46c1492e7d70.pdf"},{"id":42715583,"identity":"04ca6d8a-f908-4a75-80a1-bb7862d7f456","added_by":"auto","created_at":"2023-09-06 13:58:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":432548,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3319632/v1/f1b6d0a3-a266-4b06-9a6d-12012fd3ae24.pdf"}],"financialInterests":"","formattedTitle":"\u003cp\u003e\u003cstrong\u003eIntegrated life skill training and executive function strategies in children with autism spectrum disorder in Qatar: study protocol for a randomized controlled trial\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"1. Background","content":"\u003cp\u003eASD is a neurodevelopmental disorder characterized by socio-communicative impairments and restricted, repetitive patterns of behaviors and interests that negatively impact children\u0026rsquo;s development (DSM \u0026amp; American Psychiatric Association Publishing, 2013; Qiu \u0026amp; Yuan, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). The prevalence of autism spectrum disorder (ASD) is increasing globally with an estimate median prevalence of 65/10,000 (Zeidan et al., \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e2022\u003c/span\u003e). The Centre for Disease Control and Prevention reported that approximately 1 in 36 children 8 years of age in the USA was estimated to have ASD (Maenner et al., \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e2023\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eChildren with ASD may have other comorbidities, including epilepsy, sleep disorders, gastrointestinal disorders, toileting problems, behavioral disorders, learning disorders, attention deficit hyperactivity disorder, intellectual disability, anxiety, and depression, (Bausela-Herreras et al., \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; Maenner et al., \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e2020\u003c/span\u003e). Deficits in executive functions (EF), including working memory, inhibitory control, self-regulation, and cognitive flexibility, which involve planning and problem-solving, were also reported among children with ASD. These children require treatment programs that involve a multidisciplinary team targeting functional and life domains. Impairments in EF skills will subsequently impact participation in these domains and affect the quality of life and participation (Jaekel et al., \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e2016\u003c/span\u003e;). Therefore, developing effective intervention strategies that incorporate EF skills is crucial. To achieve this, we need to understand the nature of EF impairment in children with ASD and the reported treatment recommendation that aligns with the OT program.\u003c/p\u003e \u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003e1.1 EF impairment in children with ASD\u003c/h2\u003e \u003cp\u003eMore than half of children with ASD have impairments in EF skills, despite their intelligence quotient (IQ) being within the normal range or higher (Lai et al., \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e2017\u003c/span\u003e; Pugliese et al., \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e2016\u003c/span\u003e). Compared to typically developing children, children with ASD were reported to have impairments in all EF domains such as inhibitory control, self-regulation, planning, and problem-solving (Jones et al., \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Zimmerman et al., \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e2017\u003c/span\u003e). Impairment in EF skills could affect core ASD symptoms such as stereotypic and repetitive behaviors, thereby influencing the ASD phenotype (Demetriou et al., \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Hill, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e2004\u003c/span\u003e). For example, inhibitory control and self-regulation were found to be highly correlated with the presence of stereotypic and repetitive behaviors in children with ASD. While other EF skills such as working memory, shifting, and inhibition are suggested to be associated with other areas of core ASD symptoms such as social communication (Kaushanskaya et al., \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e2017\u003c/span\u003e; Leung et al., \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e2016\u003c/span\u003e). Consequently, children with ASD perform poorly on verbal working memory tasks than those with typical language development (Kimhi et al., \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2014\u003c/span\u003e; Van Eylen et al., \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e2015\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e1.2 EF training for children with ASD\u003c/h2\u003e \u003cp\u003eOver the last decade, several studies have investigated the effect of EF training on children with ASD. The majority of the studies reported improvement in core executive skills like problem-solving abilities, as measured via direct assessments (Stichter et al., \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e2012\u003c/span\u003e). Improvements in planning and organization skills were reported in another study using the Unstuck and On Target intervention that targets flexibility, planning, and problem-solving when compared with the social skill (SS) intervention (Kenworthy et al., \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e2014\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSelf-regulation, a key EF skill in children with ASD, has also been discussed in some studies. Following the implementation of EF training and social competence intervention, improvements were observed in participants\u0026rsquo; ability to regulate behavior and utilize cognitive resources (Scarpa \u0026amp; Reyes, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e2011\u003c/span\u003e; Thompson \u0026amp; Johnston, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e2013\u003c/span\u003e). Likewise, only a few studies have investigated the outcomes in social communication and language skills following the EF training and suggested that EF interventions are associated with improvements in social communication skills in children with ASD and better outcomes in language skills (Friedman \u0026amp; Sterling, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e2019\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eImprovements in social communication skills have also been reported in 5\u0026ndash;7-year-old children with ASD following the use of EF strategies in schools, and positive results were observed in classroom engagement, social interaction, adaptive communication, and social skills (Morgan et al., \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). Computerized EF training can also be a useful technique to improve EF skills among children with ASD of different ages when implemented by teachers in regular classrooms (de Bruin et al., \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e2013\u003c/span\u003e). However, computerized EF training was shown to be more beneficial for older children, aged 8\u0026ndash;12 years than those aged 4\u0026ndash;5 years (de Bruin et al., \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e2013\u003c/span\u003e). Conversely, non-computerized training has shown better results because it involves more in-person, trainer\u0026ndash;trainee interactions than computerized cognitive training\u003c/p\u003e \u003cp\u003e(Diamond \u0026amp; Ling, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e2019\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eMost of the published studies on EF training have examined its effectiveness in improving social communication skills when implemented as a stand-alone strategy or in combination with social communication training (Cascia \u0026amp; Barr, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e2017\u003c/span\u003e), No study had explored the outcomes of EF training in improving daily life skills (DLS) or sensory integration/processing (SI/SP) skills.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e1.3 Aim of the current study\u003c/h2\u003e \u003cp\u003eThis study aimed to (1) investigate the effects of DLS and SI/SP training combined with EF strategies and DLS and SI/SP training alone on the improvement of self-care, and SI skills in children with ASD; (2) evaluate the effects of DLS and SI/SP training on the improvement of self-care and SI skills in children with ASD; and (3) examine the effect of DLS and SI training. We hypothesize that executive function training combined with DLS and SI/SP training is more effective in improving self-care and SI skills than only DLS and SI/SP training alone in children with ASD.\u003c/p\u003e \u003c/div\u003e"},{"header":"2. Method/Design","content":"\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\n \u003ch2\u003e2.1 Study design\u003c/h2\u003e\n \u003cp\u003eThis study protocol was designed in line with other previous protocols and studies (Kenworthy et al., \u003cspan class=\"CitationRef\"\u003e2014\u003c/span\u003e; Morgan et al., \u003cspan class=\"CitationRef\"\u003e2018\u003c/span\u003e; Stackhouse et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e) that demonstrated that EF training for children with ASD can be effective and that SI/SP training and DLS training for children with ASD are also effective; however, our study goes a step further forward by combining EF training with SI/SP and DLS training.\u003c/p\u003e\n \u003cp\u003eThe current study protocol is a single-blinded, randomized control trial (RCT) with two arms: OT\u0026thinsp;+\u0026thinsp;EF (treatment) versus OT (control). The duration of intervention and length of each session will be the same for both groups in a 45-min session/week for 13 weeks. The two groups will be compared at baseline and 7 and 14 weeks of treatment (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). This study was approved by the XXXX (XXXX) and the XXXX (XXXX). Informed consent will be obtained from the parents of participants.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n \u003ch2\u003e2.2 Participants\u003c/h2\u003e\n \u003cp\u003eChildren with a confirmed diagnosis of ASD referred to the XXXX will be approached for study participation. ASD diagnosis will be confirmed by a multidisciplinary team at the XXXX. The diagnostic team included consultant neurodevelopmental pediatricians, occupational therapists, speech therapists, and psychologists. All of them specialized in ASD diagnosis. Children will be included if they have a confirmed diagnosis of ASD, have a referral to the Autism Program, and are between ages 3 and 5 years. All eligible children irrespective of their native languages will be included. Exclusion criteria include children with severe impairments in learning and linguistic acquisition skills with a score of 4 on any item of Barrier Assessment on the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) and whose parents are unwilling to give consent. Children who do not complete 13 intervention sessions and those who underwent other interventions that may affect the study results will be considered drop-outs and hence excluded from the analysis. Moreover, those who did not complete all outcome measures will be excluded from the analysis. Study screening will be performed by the Primary Investigator (PI) after the parents have given their written informed consent. Parents will be asked to come for another session during which the PI will perform screening based on the eligibility criteria. All eligible patients who will sign the consent form will be enrolled in the study. The PI will discuss the enrolment for study and confirm for parents on the same day of screening after the completion of the required assessment.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003e2.3 Sample size determination\u003c/h2\u003e\n \u003cp\u003eA priori power analysis was conducted using G*Power 3.1.9.6 considering an effect size of 80 and a 5% margin of error based on previous studies (Kenworthy et al., \u003cspan class=\"CitationRef\"\u003e2014\u003c/span\u003e; Stackhouse et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e). The results of the power analysis indicated that 67 participants are required to detect group differences at the \u0026beta;\u0026thinsp;=\u0026thinsp;.80 level and a 5% margin of error. A total of 92 children will be enrolled to account for possible attrition.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003e2.4 Randomization and blinding\u003c/h2\u003e\n \u003cp\u003eParticipants will be randomized (1:1) and assigned to the treatment or the control group using a computer-generated sequence. Baseline and outcome assessments will be performed by independent evaluators blinded to the study groups. The evaluators are trained in conducting the study assessments\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n \u003ch2\u003e2.6 Ethical considerations\u003c/h2\u003e\n \u003cp\u003eEthical approval for the study was obtained from XXXX and institutional review board XXXX.\u003c/p\u003e\n \u003cp\u003eParents of all children referred to the Autism Program will be informed about the research and those who agree to participate will be screened by the PI based on the eligibility criteria. Potential participants will be given the choice of whether to participate in the study, and additional time will be provided if required to make the decision. Informed consent will be taken from those parents whose children were eligible for the study. The participant names will be replaced by a code number in the dataset for anonymity. All collected data will be saved in a password-protected folder, only on the XXXX computer and network. Only the authors will have access to the data.\u003c/p\u003e\n \u003cp\u003eParents of children who are admitted to the Autism Program will be asked whether they agree to join the study or not; if they agree, they will be asked to sign the consent form which will be given to them by the admin nurse, in the presence of the PI. There are no major risks associated with this study; however, children may get upset while performing the tasks.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003e2.7 Study measures\u003c/h2\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eAn overview of all outcome measures from that will be used in this study is shown in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eStudy schedule for recruitment, interventions, and outcome measurements.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eStudy period\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eEnrolment\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eAllocation\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003ePost-allocation\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTimepoint (week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026minus;1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e0\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e7\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e14\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"5\"\u003e\n \u003cp\u003e\u003cstrong\u003eEnrolment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eInformed consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eEligibility (screening)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRandomization\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAllocation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eAssessment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"4\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVB-MAPP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSSP2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWeeFIM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVMI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e\n \u003ch2\u003e2.7.1 Screening measures\u003c/h2\u003e\n \u003cp\u003eThe verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) will be used to determine eligibility. VB-MAPP has five dimensions: Milestones Assessment, Barriers Assessment, which was used for inclusion criteria; Transition Assessment, Task Analysis Skills Tracking; and Placement and Individualized Education Program Goals. VB-MAPP barrier assessment uses a 5-point scale (0\u0026ndash;4), with 0 being the lowest and 4 being the highest. VB-MAPP is the most widely used instrument for curriculum development and treatment planning in the field of ASD training. Moreover, it also has good psychometric properties and is a reliable and valid measure (Padilla, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e; Padilla \u0026amp; Akers, \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e).\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e\n \u003ch2\u003e2.7.2 Outcome measures\u003c/h2\u003e\n \u003cdiv id=\"Sec14\" class=\"Section4\"\u003e\n \u003ch2\u003e2.7.2.1 Primary outcome measure\u003c/h2\u003e\n \u003cp\u003eVB-MAPP Transition Assessment will also be used for measuring improvements in self-help skills. VB-MAPP transition assessment uses a 4-point scale (1\u0026ndash;4), with 1 being the lowest and 4 being the highest. VB-MAPP transition assessment includes good psychometric properties and is a reliable and valid measure (Padilla, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e; Padilla \u0026amp; Akers, \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eWeeFIM will be used to measure improvements in self-care and social cognition skills. It consists of 18 items with three domains: self-care, mobility, and social cognition. Each item uses a seven-level method of 1\u0026ndash;7 points. In this study, only self-care and social cognition domains were used. WeeFIM is shown to demonstrate high internal consistency responsive to change and good convergent validity (Ottenbacher et al., \u003cspan class=\"CitationRef\"\u003e2000\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eShort Sensory Profile\u0026trade; 2 (SSP2) will be used to measure improvement in sensory processing. SSP2 comprises a 34-item caregiver questionnaire, and all the items are scored on a 5-point Likert scale (ranging from always to never). A lower score indicates the presence of more atypical sensory responses. SSP2 has a total score and seven subsection scores, which can be used to classify children\u0026rsquo;s sensory impairments into four categories: seeking, avoidance, sensitivity, and registration. SSP2 is one of the most commonly used measures of sensory features in children with ASD, and responsiveness to change, concurrent validity, and reliability appear satisfactory (Hand et al., \u003cspan class=\"CitationRef\"\u003e2017\u003c/span\u003e; Lajonchere et al., \u003cspan class=\"CitationRef\"\u003e2012\u003c/span\u003e; Tomchek et al., \u003cspan class=\"CitationRef\"\u003e2014\u003c/span\u003e)\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec15\" class=\"Section4\"\u003e\n \u003ch2\u003e2.7.2.2 Secondary outcome measure\u003c/h2\u003e\n \u003cp\u003eThe visual motor integration (VMI) test will be used to measure changes in visual motor integration, contains 30 items, and uses a binomial scale with 0 denoting the absence and 1 denoting the presence of skill. VMI is a widely used visual motor assessment tool because of its extensive and well-documented psychometric properties. Its inter-rater reliability ranges from 0.92\u0026ndash;0.98, and it has a test\u0026ndash;retest reliability correlation of 0.92 for a 2-week interval. Based on the norming studies (Bart et al., \u003cspan class=\"CitationRef\"\u003e2007\u003c/span\u003e), VMI is responsive to change and does not show cultural bias (Beery, \u003cspan class=\"CitationRef\"\u003e2010\u003c/span\u003e; Case-Smith, \u003cspan class=\"CitationRef\"\u003e2000\u003c/span\u003e; Green et al., \u003cspan class=\"CitationRef\"\u003e2016\u003c/span\u003e).\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n \u003ch2\u003e2.8 Intervention\u003c/h2\u003e\n \u003cp\u003eA 13-week occupational therapy training program will be conducted. One session will run each week to form 13 sessions over 13 consecutive weeks. The duration of each session will be 45 min. The program consisted of EF strategies and training, DLS training, and SI/SP training.\u003c/p\u003e\n \u003cp\u003eEF strategies and training will be conducted by a PI and a trained therapist only for the treatment group. EF strategies will be implemented during the DLS and SI training and will target the following areas: using a monitoring system for each child, improving the sense of time, externalizing important information, externalizing motivation, and personalizing the command and praise along with direct intervention at the point of performance.\u003c/p\u003e\n \u003cp\u003eChildren in the treatment and control groups will receive DLS training and SI/SP training, which focused on training children on grooming, feeding, dressing and undressing, toileting, community reintegration tasks aligned with the facilitation of fine motor skills for children, and using several techniques for activities of daily living training, including prompting, shaping, forward and backward chaining, and modeling. The training was based on the level of independency identified by the WeeFIM score.\u003c/p\u003e\n \u003cp\u003eTherapies such as deep pressure, brushing, weighted vests, and swinging will be implemented. Individually tailored treatment activities included the use of a carpeted scooter board while in a prone position to pull oneself up a ramp and then turning the scooter board around to ride down the ramp and land in a cushioned area of mats and pillows covered with various textures (Schaaf et al., \u003cspan class=\"CitationRef\"\u003e2018\u003c/span\u003e; Schoen et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e). The intervention contextualized in play with the active involvement of the child will be conducted in a large gym equipped with mats, a variety of suspended swings, large balls, a climbing wall, carpeted barrels, large inner tubes, and foam blocks with opportunities for active, guided, sensory-motor play (Cham et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Wuang et al., \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eThe control group will receive regular occupational therapy for the same duration and intensity.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\n \u003ch2\u003e2.9 Statistical considerations and data analysis\u003c/h2\u003e\n \u003cp\u003eThe primary outcome measures used in this study are VB-MAPP, SP2, and WeeFIM. The secondary outcome is VMI. Changes in the pre-test and post-test scores (Standard Score, Percentile Rank, and P-value) will be compared between the intervention and control groups using a linear-mixed regression model and the analysis of covariance (ANCOVA) using the repeated-measures analysis of variance, with comparing baseline scores with re-assessment and post-treatment scores.\u003c/p\u003e\n \u003cp\u003eThe heterogeneity of children between the treatment and control groups based on screening measures will be assessed and reported using the t-test.\u003c/p\u003e\n \u003cp\u003eAssociations between two or more categorical datasets/variables (sex, parent level of education, etc.) will be assessed using the chi-square test.\u003c/p\u003e\n \u003cp\u003eThe 95% significance level will be used when performing statistical tests. Since the hypothesis is unidirectional, we will use one-tailed test p-values.\u003c/p\u003e\n \u003cp\u003eWe will use the statistical package for social sciences (SPSS-28) to analyze our data (Wolach \u0026amp; McHale, \u003cspan class=\"CitationRef\"\u003e2008\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"3. Discussion","content":"\u003cp\u003eChildren with ASD present impairment with several EF skills with different levels of impairment. EF strategies and training are important components of the treatment program for children with ASD and can be combined with other training programs such as occupational therapy, which is the target training on SI/SP and DLS. The information on the preparation period of this study can be of great interest to other studies for designing and performing relevant studies. The findings of this study might impact the following aspects: if the treatments have the same efficacy, and if there is a difference between the two interventions in improving SI/SP and DLS in children with ASD. This might give rise to further research; moreover, investigations on other factors, such as the severity of ASD, SI/SP, and DLS training techniques and parent\u0026rsquo;s compliance with treatment and educational level might be conducted in the future. The outcome of the study will also contribute to strengthening the limited existing evidence on the efficacy of EF enhancement strategies for children with ASD. If determined effective, the program can also be integrated into the service delivery mode of an occupational therapy program in different healthcare centers for children with ASD in Qatar.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Institutional Review Board of Hamad Medical Corporation (HMC) (IRB-HMC-2021-011) and the Medical Research Center (MRC-01-22-509).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e :\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNA\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e :\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study are available on request from the corresponding author and [or first author] with reasonable restrictions. The data are not publicly available due to [laws and regulation of author organization].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e :\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBara Mohammed Yousef(Author contribution on : Methodology, Investigation\u003c/p\u003e\n\u003cp\u003eConceptualization,Data curation, role/writing -orginal draft\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNaresh Bhaskar Raj (Author contribution on :,Writing - review \u0026amp; editing, Methodology)\u003c/p\u003e\n\u003cp\u003eNadiah Wan-Arfah \u0026nbsp;(Author contribution on :,Writing - review \u0026amp; editing, Methodology)\u003c/p\u003e\n\u003cp\u003eBrightlin Nithis Dhas (Author contribution on :,Writing - review \u0026amp; editing, Methodology)\u003c/p\u003e\n\u003cp\u003eFlorence Vargas Rosal (Author contribution on : review \u0026amp; editing, investigation and resources )\u003c/p\u003e\n\u003cp\u003eAhmad Mohammad Mansour (Author contribution on : review \u0026amp; editing , investigation and resources )\u003c/p\u003e\n\u003cp\u003eRana Moufeed Ajouly (Author contribution on : review \u0026amp; editing , investigation and resources )\u003c/p\u003e\n\u003cp\u003eSamah ahmad Abd Alhadi (Author contribution on : review \u0026amp; editing , investigation and resources )\u003c/p\u003e\n\u003cp\u003eMarnel Morada Dizon (Author contribution on : review \u0026amp; editing , investigation and resources )\u003c/p\u003e\n\u003cp\u003eNadhira Sboui (Author contribution on : review \u0026amp; editing ,investigation and resources )\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003e\u003cspan\u003eBart, O., Hajami, D., \u0026amp; Bar-Haim, Y. 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Psychiatry Research, 253, 360\u0026ndash;363. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.psychres.2017.04.023\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Hamad Medical Corporation","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":"autism spectrum disorder, executive function strategies, daily life skills, sensory integration/processing, visual motor integration, occupational therapy, effectiveness","lastPublishedDoi":"10.21203/rs.3.rs-3319632/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3319632/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Executive function (EF) impairment is common in children with autism spectrum disorder (ASD). EF strategies are considered effective in improving therapeutic outcomes of children with ASD. This study primarily aims to explore whether integrating EF strategies combined with regular occupational therapy intervention is more effective in improving daily life skills (DLS) and sensory integration/processing (SI/SP) skillsthan regular occupational therapy alone in children with ASD and secondarily aimsto assess treatment outcomes on improving visual motor integration (VMI) skills.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e A total of 92 children with ASD will be recruited and following baseline assessments randomly assigned to the treatment group (45-min once weekly individual occupational therapy plus EF strategies) and control group (45-min once weekly individual therapy sessions alone).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e All children will be evaluated systematically by assessing SI/SP, DLS, and VMI, skills at baseline, 7 weeks, and 14 weeks of treatment. Data will be analyzed using analysis of covariance and t-test. This single-blind randomized controlled trial will provide empirical evidence for the effectiveness of EF strategies when combined with regular occupational therapy programs. Based on trial results, EF strategies could be recommended in multidisciplinary programs for children with ASD.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial registration\u003c/strong\u003e: This trial has been registered on the clinicaltrail.gov for registry, protocol ID: MRC-01-22-509 ClinicalTrials.gov Identifier: NCT05829577, registered April 25, 2023.\u003c/p\u003e","manuscriptTitle":"Integrated life skill training and executive function strategies in children with autism spectrum disorder in Qatar: study protocol for a randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-09-06 13:58:29","doi":"10.21203/rs.3.rs-3319632/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":"9b6a4330-2405-4949-abed-d536531331dd","owner":[],"postedDate":"September 6th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":24404055,"name":"Physical Medicine \u0026 Rehab"}],"tags":[],"updatedAt":"2023-09-06T13:58:30+00:00","versionOfRecord":[],"versionCreatedAt":"2023-09-06 13:58:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3319632","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3319632","identity":"rs-3319632","version":["v1"]},"buildId":"_2-kVJe1T_tPrBINL-cwx","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}