The implementation of a school-based face to face group intervention for young people with Adverse Childhood Experiences in Wales: a feasibility study protocol

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Young people exposed to ACEs face an increased risk of health problems both at time of exposure and after the experience. Early intervention to develop emotional coping skills for those living through adverse experiences can be beneficial. The EASE (Early Adolescents Skills for Emotions) is a group intervention for young people who have experienced adversity, suitable for delivery by non-clinicians such as teachers. This study will report an implementation protocol for assessing the feasibility, retention and acceptability of the EASE intervention in order to inform the development of a larger efficacy trial. Methods This study is a single-arm, open-label, pilot trial. A total of 20 children and their caregivers will be recruited from two school sites. Participants will attend a seven-session group intervention which includes elements of mindfulness and behaviour activation. Participants’ caregivers also attend three concurrent sessions. To assess feasibility, we will examine recruitment, retention and participation rates: Can 16-20 families in 2 schools be recruited, and do 14 remain to the end with 50% or more of sessions attended? Participants will also complete a measure of internalising distress at baseline and post-intervention, with no long-term follow up. Acceptability will be evaluated through qualitative interviews post-intervention. Discussion This study will establish the feasibility of a novel intervention aimed at promoting coping strategies and reducing internalising distress amongst young people who have experienced ACEs. The EASE intervention will be modified through stakeholder feedback and optimised for the Welsh context. Evidence from this study will be useful to families, school staff and healthcare professionals in supporting adolescent mental health and will serve as a model for a future trial to examine efficacy of the proposed intervention. ISRCTN study registration number: ISRCTN91291368. Adverse Childhood Experiences mental health wellbeing intervention behavioural activation group intervention family support adolescents Background Adverse Childhood Experiences (ACEs) are potentially traumatic experiences occurring before the age of 18, such as child maltreatment or witnessing domestic violence within the family home ( 1 ). Young people exposed to ACEs are at increased risk of a range of long term physical and mental health problems ( 2 ). ACEs are thought to affect around half of the general population ( 3 ); being so widespread, a universal approach to supporting those affected by ACEs may be appropriate. Schools are now a key setting providing wellbeing support to young people ( 4 ). Because schools are in regular contact with so many families, they represent a promising potential site for interventions targeting ACEs to be delivered. Schools are generally an acceptable site for young people to access support with managing the impact of ACEs ( 5 ). Interventions which can be delivered by non-clinicians are important for schools because access to clinicians is limited in school settings, with teachers and teaching assistants often taking responsibility for providing wellbeing interventions. However, there is a lack of evidence for interventions which can be effective when delivered by a non-clinician ( 6 ). Intervention The EASE (Early Adolescents Skills for Emotions) is an intervention developed by the WHO (World Health Organization). It is a group intervention for young people (10–15 years) who have experienced adversity and it is suitable for non-clinician delivery. Parents also attend complementary sessions. There is evidence of the effectiveness of EASE ( 7 ), but it has never been trialled in a UK setting. This study will report an implementation protocol for assessing the feasibility and acceptability of EASE in a UK setting. Adapted intervention EASE is an international intervention which is designed to be culturally adapted. To facilitate this, we have held co-production workshops with stakeholders. One workshop was held with a user group of a charity supporting single parent families, to represent caregiver participants of EASE. The intervention materials were and participants offered their feedback on how they would feel if this was offered out through their child’s school, whether they would be comfortable speaking to someone from a university on this basis, and what could make it easier for them to understand to research, want to take part or be able to take part. The findings from this workshop informed how initial conversations with potential trial participants were approached, including how to sensitively approach the screening questions and information sharing around ACEs. There was also some useful discussion around the role of the family liaison officer in a school (who would act as the linked member of staff for this pilot) and practical considerations around timings of the caregiver sessions, which were integrated into how the research was presented to potential participants. Workshops with 16–18-year-olds with recent experience of the Welsh school system were also held. Participants were health and social care students at a college in the Caerphilly borough. Participants annotated the EASE materials and responded to prompt questions concerning the suitability of the text and the illustrations. Following the workshop, the illustrations were adapted in line with their recommendations including adding more colour and more detail, and some Welsh representation such as Welsh flags in the background. Workshop participants also compiled links to illustration styles which they thought would be more appropriate and these served as a mood board for the adapted illustrations. The ‘storybook’ text was adapted to include two ‘main characters’ rather than one, to make it more relatable, with different family compositions for each character. A character with ALN (Additional learning needs) was also included. Participants also suggested including short Welsh words in the story, changing the character names and making it shorter and clearer. This process ensured the workshop materials were more specific to the Welsh context and them culturally relevant. The EASE facilitator (FA) also undertook supervision with a counselling psychologist and discussed adaptations to the intervention to suit the legal and professional context of working in Welsh schools. Practical adaptations were also made to suit the Welsh context. The usual age range for EASE is 10–15. In Wales, children move from primary to secondary school in the year they turn 12. Discussions with school staff highlighted that a lower age limit of 10 years creates a cut off in the middle of the school year for Year 5 which is somewhat arbitrary for the school staff who are selecting pupils. The age range for this pilot therefore was changed to 9.5–12 years to cover pupils in the final two year groups of primary school. This adaptation was also considered when adapting the resources in terms of ensuring the materials are accessible to younger participants. Feasibility trial objectives The primary objective of this study is to determine the acceptability and feasibility of the EASE group intervention in a Welsh context. We will use a mixed methods design utilising quantitative and qualitative methods. We will determine acceptability and feasibility through assessing consent and assent rates, as well as session and programme completion rates. We will assess the acceptability of our assessment measures by looking at completion rates. Participants (young people and caregivers) and school staff will be asked to take part in qualitative, semi-structured exit interviews following intervention delivery. Progression Criteria Feasibility of the intervention will be assessed using progression criteria which were: 1. Site recruitment. Can a minimum of two school sites be recruited from one local authority in three months? 2. Site retention. Can a minimum of two school sites be retained until the end of the study? 3. Participant recruitment. Can 8–10 participants per site be recruited? 4. Participant retention. Can a minimum of 7 participants per site be retained until study end with 50% or more sessions attended? 5. Intervention feasibility. Was the intervention feasible for delivery (based on qualitative data)? The decision to progress to a full trial will be based on an assessment of this criteria using Stop/Amend/Go ( 8 ). Methods Design overview This single-arm, open-label, pilot trial will examine implementation outcomes (feasibility, self- and caregiver-reported measures) of the EASE. The intervention will involve seven weekly group sessions for young people and three additional sessions for their caregivers. Study setting We will recruit participants from two primary schools in Caerphilly County Borough, South Wales. We approached the Caerphilly Educational Psychology Service regarding their interest in the study and willingness to publicise the opportunity to take part to schools across the borough. Schools who expressed an interest were then individually approached and consent gained for schools to act as a gatekeeper to accessing potential participants for each group from those enrolled at the school. Four schools initially expressed an interest in being part of the pilot and were approached for a meeting. Of these, two signed gatekeeper consent forms, whilst one school elected not to take part following the meeting as the school was an ALN setting and the intervention would require further adaptation, and one further school did not respond in time to requests for an initial meeting. Selected schools are attended by a sizeable proportion of young people from low-income families; the percentage of children eligible for Free School Meals (a measure of poverty in the UK) at each school is above average. We will aim to recruit 8–10 participants from each primary school. This number is chosen as the ideal class size if this intervention was expanded to be delivered in local schools. The size enables benefits of being part of a group but small enough to enable more individual working with pupils. Two schools have been chosen to examine variation in implementation in different schools but with the limitation of one trainer delivering the feasibility study. The selection of two schools and variation needed between schools can inform the extent to which the intervention can be standardised and the level to which flexibility is needed to deliver in different schools. This will inform the design of a national trial involving 22 local authorities across Wales. Ethical considerations The Swansea University Medical School Ethics Sub-Committee approved the study on 27 September 2024 (Research Ethics Approval Number: 4 2024 10283 10467). All young person participants will be informed about the intervention and provided with an accessible information sheet. Adolescent assent and parental/caregiver consent will be sought for participation in the study; both are required for participation. Parent/caregivers will also give consent for their own participation in the study. Participants will be advised and reminded of their right to withdraw from the study at any time and their right to choose not to answer questions if they would prefer not to. Participants The inclusion criteria for the study are: (i) Young people aged 9.5–12 years enrolled at a participating school, and their caregivers (ii) Caregiver has given consent and young person has given their assent (iii) Young person has experienced at least one Adverse Childhood Experience (ACE) (iv) Young person is struggling with internalising distress such as sadness or worry The exclusion criteria for the study are: (i) Young people who are self-harming or at imminent risk of suicide (ii) Young people with significant challenges such as psychosis or alcohol dependency (iii) Young people who are currently on a child protection plan (e.g. subject to safeguarding proceedings) (iv) Young people who are currently accessing another therapeutic intervention such as school-based counselling Recruitment, screening, and enrolment The first author (FA) acts as researcher and facilitator for this trial, including school and participant liaison, screening, delivering the intervention and interviewing participants. This trial is a part of FA’s PhD research and therefore resources for recruiting, training and supervising independent intervention facilitators are extremely limited. This is particularly the case given that prior to preparation for this trial commencing, there were no individuals trained in EASE. School staff will be briefed on the study and will identify young people who are likely to meet the eligibility criteria using a short screening tool. Young people will then be invited to take part in Phase 1 of the study which is the pre-assessment. Young people and their caregivers will be fully briefed on this phase of the study and be given the opportunity to ask questions before providing their assent and consent. Young people will then complete the pre-assessment in person with the researcher (FA) on the school site. Caregivers will complete their pre-assessment in person on the school site or over the phone. Participants will be allocated to groups according to the school they attend. Phase 1 is scheduled to be completed in December 2024. Participants who are eligible to take part based on their pre-assessment will be invited to take part in Phase 2 of the study which is attending the intervention group and the post-assessment (a brief assessment which contains some repeated measures from the pre-assessment). Young people and caregivers will be briefed on the intervention and asked to sign the consent and assent form. The intervention group composed of seven adolescent sessions and three caregiver sessions will be delivered on the school site during the school day by a member of the research team. Participants who do not attend sessions will receive the content in a catch up session over the phone or in person. Recruitment to the intervention will finish in January 2025. Phase 2 is scheduled to begin in January 2025 and finish by March 2025. A sub-section of participants will be invited to take part in Phase 3 of the study which is qualitative interviews. School staff will also be invited to take part in Phase 3. This is to assess and gain insight into the feasibility and acceptability of the EASE group. Young people, caregivers and school staff will be briefed on this phase of the study and asked to sign the consent and assent form. Phase 3 is scheduled to begin in March 2025. Young people and caregivers will be briefed on the intervention and asked to sign the consent and assent form. The ideal group size for EASE is 8–12 participants and so the aim is to recruit 10–12 participants from each site. Study intervention The EASE intervention is aimed at 10–15 year olds who have experienced adversity and who are affected by internalising distress such as sadness or worry. EASE is adapted from cognitive behavioural therapy and optimised for delivery by non-clinicians. The intervention aims to support young people and their caregivers with skills to reduce distress. These skills include identifying feelings, stress management, behavioural activation and problem solving as these have been identified as components of evidence-based treatments which are suitable to be adapted for non-clinician delivery. The intervention is designed to be adapted for different cultural contexts. This study will use a version of EASE adapted for a Welsh cultural background. The intervention will also be adapted for a younger age range of 9.5–12 years as this is consistent with the Welsh education system and the age range covered by Year 5 and Year 6. The group size will be 8–12 participants for both the young person group and the caregiver group. Participants will complete self-report measures on internalising distress. The EASE materials are freely available at https://www.who.int/publications/i/item/9789240082755 Intervention content Adolescent session 1: Understanding My Feelings Participants will receive an overview of the aims of EASE. Group rules will be set collaboratively, including the importance of confidentiality and when this cannot be adhered to. Participants will be introduced to the intervention materials including the Storybook. Participants will complete discussion, drawing and writing activities to support identifying how difficult feelings might arise in stressful situations and how to recognise their own feelings accurately. For home practice, participants will be asked to practice identifying which feelings they experience each day using the Feelings Pot worksheet. The session will end with an activity to identify participants’ individual strengths. This will be repeated as a closing activity for all adolescent sessions. Adolescent session 2: Calming My Body The session will begin with a review of the previous session and the associated home practice. Participants will be supported to review any previous aspects of the intervention which they did not understand and to manage any problems arising from completing the home practice. Participants will then learn about how feelings are experienced in the body as sensations, using a Body Map poster, before discussing possible helpful coping strategies for managing difficult feelings. Participants will identify the difference between helpful and unhelpful coping strategies. The Slow Breathing activity will be introduced as a potential helpful strategy for calming our bodies. Slow Breathing and the Body Map activity will be added as home practice activities. Adolescent session 3: Changing My Actions 1 Participants will review previous sessions and home practice to consolidate learning and deepen understanding of the skills. Participants will complete an activity using the Storybook and the Vicious Cycle poster to learn about how feelings can affect actions and behaviours, which can then contribute to maintaining the problem or can make difficult feelings worse. The Changing My Actions activity will be introduced as a way of using planning strategies to do meaningful things to help improve feelings. Changing My Actions will be introduced as a home practice activity alongside the home practice activities from previous weeks. Adolescent session 4: Changing My Actions 2 Previous skills will be reviewed, and participants will reflect on their experience of practicing Slow Breathing and Changing My Actions in home practice. Participants will learn more about how to gradually engage in activities to help improve mood. Participants will complete activities to support them with practicing Changing My Actions outside of the intervention sessions. Home practice of all the skills will be set again. Adolescent session 5: Managing My Problems 1 All previous skills will be reviewed, and participants will be supported through troubleshooting of any difficulties with home practice. Participants will complete a group discussion activity to introduce the idea of common problems which might be faced by adolescents and how participants can support each other to manage problems. Participants will complete the Managing My Problems group activity using the Stop, Think, Go poster, and then plan how to use this strategy for a personal problem. This will then be added to the home practice. Adolescent session 6: Managing My Problems 2 Participants will reflect on their experience of home practice and continue to develop their skills in problem management by applying the Stop, Think, Go framework to a new problem. Participants will be encouraged to support and learn from each other, and to feel empowered to use the intervention skills with greater independence. Participants will complete an activity in anticipation of the end of the intervention, reflecting on their feelings associated with finishing and using the skills they have learned to plan how to manage any difficult feelings which may arise. Adolescent session 7: Brighter Futures Participants will review all intervention content, and use role play to support participants to think of new ideas for solving their problems. Participants will explore how to continue to use the skills which they have learned in the future. Participants will complete a craft activity to help them remember and consolidate the EASE skills. The session will end with a closing activity to celebrate participants’ strengths and achievements in completing the intervention, and participants will receive certificates. Participants will share one positive thing about the EASE group and one goal they have for the future. Caregiver session 1: Understanding Big Feelings Participants will receive an overview of the aims of EASE, including the aims and content of the adolescent sessions. Group rules will be set collaboratively, including the importance of confidentiality and when this cannot be adhered to. Participants will be introduced to the intervention materials and the adolescent sessions will be summarised, including the importance of home practice. Participants will complete discussion activities to learn the causes and signs of big feelings in adolescence, including the physical sensations big feelings may cause. Guidance will be provided around situations where adolescents make reference to ending their life and how to safely provide support in this situation. Participants will then complete a role play activity around how to soothe and use active listening when responding to big feelings. Participants will be given an explanation about the importance of quality time with a child and how to overcome barriers to quality time. The session will end with a slow breathing activity. For home practice, participants will be asked to practice active listening and spend quality time with their child before the next session. Caregiver session 2: The Power of Praise The session will begin with a review of home practice. Participants will be supported to manage any problems arising from completing the home practice. Participants will then learn about the skills being taught to their child in the EASE adolescent group. Participants will complete a discussion activity reflecting on their child’s individual strengths. Participants will learn about the importance of giving and receiving praise and roleplay effective praise. Participants will learn about alternative approaches to behaviour management rather than using harsh punishment. The session will end with a summary and active listening and praise will be set as home practice Caregiver session 3: Caregiver self-care and brighter futures Participants will review previous intervention content, reflect on their experience of home practice, and discuss how best to support their children with ongoing home practice. Participants will complete a discussion activity around identifying and celebrating their strengths. They will then learn about the importance of self-care and how to overcome barriers to self-care. Participants will receive an explanation of how they can keep supporting their child with their EASE skills. The session will end with a closing activity in which participants will share one positive thing about the EASE group and be encouraged to keep supporting each other and using the techniques they have learned. Participants will also be signposted to potential future sources of support which they or their child might need. Intervention facilitators Sessions will be conducted by a member of the research team (FA) who is a current PhD student and also an experienced teacher and safeguarding professional, with experience of delivering similar psychoeducational groups to adolescents. FA received EASE training from a chartered counselling psychologist and will access ongoing supervision from this psychologist throughout the intervention. Implementation outcomes Feasibility Feasibility measures the extent to which a new intervention can be successfully conducted in a specific context. This outcome will be measured by recruitment, retention and participation rates. It will also be assessed through coproduction workshops and qualitative feedback. The success of feasibility will be determined by a recruitment rate of at least 8 adolescents at each site and a retention and participation rate of at least 90%. Acceptability Acceptability will be assessed through post-intervention interviews with a sample of adolescents, caregivers and school staff who were involved in the programme. Interviews will take place in a private classroom or office on the school premises, or optionally over the phone or video call for adults. All participants will be invited to take part in the interviews. Following assent and parental/caregiver, approximately three adolescents and three caregivers will be invited to interview. A random stratified selection will be made to include both male and female participants. Interviews will be conducted by the programme facilitators. Interviews will be audio-recorded with permission from participants. Participant self-report measures Participants will complete self-report measures on internalising distress to check these measures are appropriate for a subsequent trial and to inform a power calculation for a subsequent trial. The measure will be the internalising problems subscale from the Paediatric Symptom Checklist (PSC-17). Demographic information including age and gender will also be collected at baseline assessment. Schools will provide an overview of the family background and the ACEs experienced by participants. Data analysis Demographics and feasibility outcomes will be summarised using descriptive statistics to explore recruitment, retention and participation rates. Quantitative data will be analysed using SPSS Statistics. Qualitative data from interviews will be transcribed verbatim and will be uploaded into NVivo to be analysed. Codes and subsequent themes will be deductively developed insofar as codes will be organised according to the question of to what extent the intervention is acceptable to participants. Discussion School-based interventions for young people affected by ACEs are a promising way to decrease distress, which could reduce the negative impact of ACEs in the long term. Around half of the population are estimated to have at least one ACE, and therefore this population is an important group to target. This study will be the first to trial EASE in a UK population. If this trial is successful, it would lead to a larger scale independent trial to investigate if the EASE intervention could be used in Wales to promote skills for young people living with adversity to mitigate the negative long-term outcomes associated with ACEs. This would improve the quality of life of this population and save health-related costs associated with ACEs in the long term. A review identified limited evidence for interventions suitable for delivery by school staff; there is a need to develop the evidence base for mental health interventions which are suitable for delivery by non-clinicians and which could help to mediate against the negative impact of ACEs ( 6 ). The intervention reported in this protocol could be scaled up to a national level to reach many young people and families living in adversity. The coproduction and implementation considerations of this study are important features which would support a larger trial to address real-life implementation challenges and effectively scale up in a Welsh context.. Findings will be disseminated through a publication in a peer reviewed journal and by sharing accessible findings to a wider audience of stakeholders including schools and local authorities. Abbreviations Adverse Childhood Experiences (ACEs) EASE (Early Adolescents Skills for Emotions) WHO (World Health Organisation) Paediatric Symptom Checklist (PSC-17) Additional Learning Need (ALN) Declarations Ethics approval and consent to participate The Swansea University Medical School Ethics Sub-Committee approved the study on 27 September 2024 (Research Ethics Approval Number: 4 2024 10283 10467). Young person assent and parental/caregiver consent will be sought for participation in the study; both are required for participation. Parent/caregivers will also give consent for their own participation in the study. Consent for publication All participants provided consent for publication of anonymised data. Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests Funding Public Health Wales and ESRC provided funding for this research through their support of a PhD studentship (FA). Authors' contributions FA is the corresponding author and was responsible for the conception and design of the project and will lead on analysis and interpretation of data. She is also responsible for the initial draft of this manuscript SB provided supervisory oversight regarding the conception and design of the project and was responsible for securing funding, and also provided comments on drafts of this manuscript. KH provided supervisory oversight regarding the conception and design of the project and provided comments on drafts of this manuscript. LG provided comments on drafts of this manuscript. Acknowledgements Many thanks to Dr Jasminder Bahia for providing counselling supervision on this project and to Dr Michaela James for providing advice concerning coproduction activities. References Anda RF, Felitti VJ, Bremner JD, Walker JD, Whitfield C, Perry BD, et al. The enduring effects of abuse and related adverse experiences in childhood. European Archives of Psychiatry and Clinical Neuroscience 2005 256:3 [Internet]. 2005 Nov 29 [cited 2023 Jun 16];256(3):174–86. Available from: https://link.springer.com/article/10.1007/s00406-005-0624-4 Bellis MA, Hughes K, Leckenby N, Hardcastle KA, Perkins C, Lowey H. Measuring mortality and the burden of adult disease associated with adverse childhood experiences in England: A national survey. Journal of Public Health (United Kingdom). 2015 Sep 1;37(3):445–54. Bellis MA, Hughes K, Ford K, Ramos Rodriguez G, Sethi D, Passmore J. Life course health consequences and associated annual costs of adverse childhood experiences across Europe and North America: a systematic review and meta-analysis. Lancet Public Health [Internet]. 2019 Oct 1 [cited 2024 Feb 9];4(10):e517. Available from: /pmc/articles/PMC7098477/ Hoover S, Bostic J. Schools as a vital component of the child and adolescent mental health system. Psychiatric Services [Internet]. 2021 Jan 1 [cited 2024 May 22];72(1):37–48. Available from: https://ps.psychiatryonline.org/doi/10.1176/appi.ps.201900575 Avery F, James M, Cowley LE, Griffiths L, Bellis MA, Hughes K, et al. “Support for my dad would have benefited me because I was the one looking after him”: A qualitative analysis of the support needs of young people exposed to Adverse Childhood Experiences. medRxiv [Internet]. 2024 Oct 28 [cited 2024 Dec 5];2024.10.25.24316104. Available from: https://www.medrxiv.org/content/10.1101/2024.10.25.24316104v1 Avery F, Kennedy N, James M, Jones H, Amos R, Bellis M, et al. A systematic review of non-clinician trauma-based interventions for school-age youth. PLoS One [Internet]. 2024 Sep 1 [cited 2024 Sep 27];19(9):e0293248. Available from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0293248 Bryant RA, Malik A, Aqel IS, Ghatasheh M, Habashneh R, Dawson KS, et al. Effectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial. PLoS Med. 2022 Aug 1;19(8). Mellor K, Albury C, Dutton SJ, Eldridge S, Hopewell S. Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud [Internet]. 2023 Dec 1 [cited 2025 Feb 3];9(1):1–10. Available from: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01291-5 Cite Share Download PDF Status: Under Review Version 1 posted Reviewers invited by journal 21 Aug, 2025 First submitted to journal 07 Feb, 2025 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. 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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-5671004","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":509218063,"identity":"1e7a00ce-7065-4148-807d-a1a153195b8e","order_by":0,"name":"Flo Avery","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+klEQVRIiWNgGAWjYBACfvbmgw8/8PyTQxFlbMCjRbLnWLKxhMwBY+K1GNzIMRPgsTmQiKIIrxaGAwlmDBI5d9Lnz0h+9vBHhR0Df/sBNskZeHQwNhxIe1Bw5lnuhhtp5sY8Z5IZJM4ksEluwKOFmbHhuIFkD3PuBukEM2nGNmYGhhsMbJIP8GhhY2Zsk+D9x5wuPzv9m+TPf/UM8oS08LAxs0nw8BxOYLidYybB23AYGCAM+B0mAdRjLMGTZrjh/psyaZ5jx3kMzyQ2W+Lzvv399x+BUWkjL99zfJvkj5pqObnjhw/e7MGjBdOlhGJlFIyCUTAKRgERAACxLk1EDcqgZAAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0002-6700-364X","institution":"Swansea University","correspondingAuthor":true,"prefix":"","firstName":"Flo","middleName":"","lastName":"Avery","suffix":""},{"id":509218064,"identity":"ce6cce88-8038-42e1-af3c-bb17b8f7d141","order_by":1,"name":"Karen Hughes","email":"","orcid":"","institution":"Public Health Wales NHS Trust","correspondingAuthor":false,"prefix":"","firstName":"Karen","middleName":"","lastName":"Hughes","suffix":""},{"id":509218065,"identity":"97ae5fb7-13b6-455a-b65d-b50a370ca6d3","order_by":2,"name":"Lucy Griffiths","email":"","orcid":"","institution":"Swansea University","correspondingAuthor":false,"prefix":"","firstName":"Lucy","middleName":"","lastName":"Griffiths","suffix":""},{"id":509218066,"identity":"fdd49778-b901-4e09-bd8d-5d4b35273c29","order_by":3,"name":"Sinead Brophy","email":"","orcid":"","institution":"Swansea University","correspondingAuthor":false,"prefix":"","firstName":"Sinead","middleName":"","lastName":"Brophy","suffix":""}],"badges":[],"createdAt":"2024-12-18 16:15:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5671004/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5671004/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":90799961,"identity":"988f4b22-c2f1-4152-89f6-d8dc0abd8fc5","added_by":"auto","created_at":"2025-09-08 10:01:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":504000,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5671004/v1/bf65f6c8-236c-4137-89f1-eb4bc20a9817.pdf"}],"financialInterests":"","formattedTitle":"The implementation of a school-based face to face group intervention for young people with Adverse Childhood Experiences in Wales: a feasibility study protocol","fulltext":[{"header":"Background","content":"\u003cp\u003eAdverse Childhood Experiences (ACEs) are potentially traumatic experiences occurring before the age of 18, such as child maltreatment or witnessing domestic violence within the family home (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Young people exposed to ACEs are at increased risk of a range of long term physical and mental health problems (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). ACEs are thought to affect around half of the general population (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e); being so widespread, a universal approach to supporting those affected by ACEs may be appropriate.\u003c/p\u003e\u003cp\u003eSchools are now a key setting providing wellbeing support to young people (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Because schools are in regular contact with so many families, they represent a promising potential site for interventions targeting ACEs to be delivered. Schools are generally an acceptable site for young people to access support with managing the impact of ACEs (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Interventions which can be delivered by non-clinicians are important for schools because access to clinicians is limited in school settings, with teachers and teaching assistants often taking responsibility for providing wellbeing interventions. However, there is a lack of evidence for interventions which can be effective when delivered by a non-clinician (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\n\u003ch3\u003eIntervention\u003c/h3\u003e\n\u003cp\u003eThe EASE (Early Adolescents Skills for Emotions) is an intervention developed by the WHO (World Health Organization). It is a group intervention for young people (10\u0026ndash;15 years) who have experienced adversity and it is suitable for non-clinician delivery. Parents also attend complementary sessions. There is evidence of the effectiveness of EASE (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e), but it has never been trialled in a UK setting. This study will report an implementation protocol for assessing the feasibility and acceptability of EASE in a UK setting.\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eAdapted intervention\u003c/h2\u003e\u003cp\u003eEASE is an international intervention which is designed to be culturally adapted. To facilitate this, we have held co-production workshops with stakeholders. One workshop was held with a user group of a charity supporting single parent families, to represent caregiver participants of EASE. The intervention materials were and participants offered their feedback on how they would feel if this was offered out through their child\u0026rsquo;s school, whether they would be comfortable speaking to someone from a university on this basis, and what could make it easier for them to understand to research, want to take part or be able to take part. The findings from this workshop informed how initial conversations with potential trial participants were approached, including how to sensitively approach the screening questions and information sharing around ACEs. There was also some useful discussion around the role of the family liaison officer in a school (who would act as the linked member of staff for this pilot) and practical considerations around timings of the caregiver sessions, which were integrated into how the research was presented to potential participants.\u003c/p\u003e\u003cp\u003eWorkshops with 16\u0026ndash;18-year-olds with recent experience of the Welsh school system were also held. Participants were health and social care students at a college in the Caerphilly borough. Participants annotated the EASE materials and responded to prompt questions concerning the suitability of the text and the illustrations. Following the workshop, the illustrations were adapted in line with their recommendations including adding more colour and more detail, and some Welsh representation such as Welsh flags in the background. Workshop participants also compiled links to illustration styles which they thought would be more appropriate and these served as a mood board for the adapted illustrations. The \u0026lsquo;storybook\u0026rsquo; text was adapted to include two \u0026lsquo;main characters\u0026rsquo; rather than one, to make it more relatable, with different family compositions for each character. A character with ALN (Additional learning needs) was also included. Participants also suggested including short Welsh words in the story, changing the character names and making it shorter and clearer. This process ensured the workshop materials were more specific to the Welsh context and them culturally relevant. The EASE facilitator (FA) also undertook supervision with a counselling psychologist and discussed adaptations to the intervention to suit the legal and professional context of working in Welsh schools.\u003c/p\u003e\u003cp\u003ePractical adaptations were also made to suit the Welsh context. The usual age range for EASE is 10\u0026ndash;15. In Wales, children move from primary to secondary school in the year they turn 12. Discussions with school staff highlighted that a lower age limit of 10 years creates a cut off in the middle of the school year for Year 5 which is somewhat arbitrary for the school staff who are selecting pupils. The age range for this pilot therefore was changed to 9.5\u0026ndash;12 years to cover pupils in the final two year groups of primary school. This adaptation was also considered when adapting the resources in terms of ensuring the materials are accessible to younger participants.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eFeasibility trial objectives\u003c/h3\u003e\n\u003cp\u003eThe primary objective of this study is to determine the acceptability and feasibility of the EASE group intervention in a Welsh context. We will use a mixed methods design utilising quantitative and qualitative methods. We will determine acceptability and feasibility through assessing consent and assent rates, as well as session and programme completion rates. We will assess the acceptability of our assessment measures by looking at completion rates. Participants (young people and caregivers) and school staff will be asked to take part in qualitative, semi-structured exit interviews following intervention delivery.\u003c/p\u003e\n\u003ch3\u003eProgression Criteria\u003c/h3\u003e\n\u003cp\u003eFeasibility of the intervention will be assessed using progression criteria which were:\u003c/p\u003e\u003cp\u003e1. Site recruitment. Can a minimum of two school sites be recruited from one local authority in three months?\u003c/p\u003e\u003cp\u003e2. Site retention. Can a minimum of two school sites be retained until the end of the study?\u003c/p\u003e\u003cp\u003e3. Participant recruitment. Can 8\u0026ndash;10 participants per site be recruited?\u003c/p\u003e\u003cp\u003e4. Participant retention. Can a minimum of 7 participants per site be retained until study end with 50% or more sessions attended?\u003c/p\u003e\u003cp\u003e5. Intervention feasibility. Was the intervention feasible for delivery (based on qualitative data)?\u003c/p\u003e\u003cp\u003eThe decision to progress to a full trial will be based on an assessment of this criteria using Stop/Amend/Go (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003eDesign overview\u003c/h2\u003e\u003cp\u003eThis single-arm, open-label, pilot trial will examine implementation outcomes (feasibility, self- and caregiver-reported measures) of the EASE. The intervention will involve seven weekly group sessions for young people and three additional sessions for their caregivers.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eStudy setting\u003c/h2\u003e\u003cp\u003eWe will recruit participants from two primary schools in Caerphilly County Borough, South Wales. We approached the Caerphilly Educational Psychology Service regarding their interest in the study and willingness to publicise the opportunity to take part to schools across the borough. Schools who expressed an interest were then individually approached and consent gained for schools to act as a gatekeeper to accessing potential participants for each group from those enrolled at the school. Four schools initially expressed an interest in being part of the pilot and were approached for a meeting. Of these, two signed gatekeeper consent forms, whilst one school elected not to take part following the meeting as the school was an ALN setting and the intervention would require further adaptation, and one further school did not respond in time to requests for an initial meeting. Selected schools are attended by a sizeable proportion of young people from low-income families; the percentage of children eligible for Free School Meals (a measure of poverty in the UK) at each school is above average.\u003c/p\u003e\u003cp\u003eWe will aim to recruit 8\u0026ndash;10 participants from each primary school. This number is chosen as the ideal class size if this intervention was expanded to be delivered in local schools. The size enables benefits of being part of a group but small enough to enable more individual working with pupils. Two schools have been chosen to examine variation in implementation in different schools but with the limitation of one trainer delivering the feasibility study. The selection of two schools and variation needed between schools can inform the extent to which the intervention can be standardised and the level to which flexibility is needed to deliver in different schools. This will inform the design of a national trial involving 22 local authorities across Wales.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eEthical considerations\u003c/h3\u003e\n\u003cp\u003e The Swansea University Medical School Ethics Sub-Committee approved the study on 27 September 2024 (Research Ethics Approval Number: 4 2024 10283 10467). All young person participants will be informed about the intervention and provided with an accessible information sheet. Adolescent assent and parental/caregiver consent will be sought for participation in the study; both are required for participation. Parent/caregivers will also give consent for their own participation in the study. Participants will be advised and reminded of their right to withdraw from the study at any time and their right to choose not to answer questions if they would prefer not to.\u003c/p\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003eThe inclusion criteria for the study are:\u003c/p\u003e\u003cp\u003e(i) Young people aged 9.5\u0026ndash;12 years enrolled at a participating school, and their caregivers\u003c/p\u003e\u003cp\u003e(ii) Caregiver has given consent and young person has given their assent\u003c/p\u003e\u003cp\u003e(iii) Young person has experienced at least one Adverse Childhood Experience (ACE)\u003c/p\u003e\u003cp\u003e(iv) Young person is struggling with internalising distress such as sadness or worry\u003c/p\u003e\u003cp\u003eThe exclusion criteria for the study are:\u003c/p\u003e\u003cp\u003e(i) Young people who are self-harming or at imminent risk of suicide\u003c/p\u003e\u003cp\u003e(ii) Young people with significant challenges such as psychosis or alcohol dependency\u003c/p\u003e\u003cp\u003e(iii) Young people who are currently on a child protection plan (e.g. subject to safeguarding proceedings)\u003c/p\u003e\u003cp\u003e(iv) Young people who are currently accessing another therapeutic intervention such as school-based counselling\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eRecruitment, screening, and enrolment\u003c/h2\u003e\u003cp\u003eThe first author (FA) acts as researcher and facilitator for this trial, including school and participant liaison, screening, delivering the intervention and interviewing participants. This trial is a part of FA\u0026rsquo;s PhD research and therefore resources for recruiting, training and supervising independent intervention facilitators are extremely limited. This is particularly the case given that prior to preparation for this trial commencing, there were no individuals trained in EASE.\u003c/p\u003e\u003cp\u003eSchool staff will be briefed on the study and will identify young people who are likely to meet the eligibility criteria using a short screening tool. Young people will then be invited to take part in Phase 1 of the study which is the pre-assessment. Young people and their caregivers will be fully briefed on this phase of the study and be given the opportunity to ask questions before providing their assent and consent. Young people will then complete the pre-assessment in person with the researcher (FA) on the school site. Caregivers will complete their pre-assessment in person on the school site or over the phone. Participants will be allocated to groups according to the school they attend. Phase 1 is scheduled to be completed in December 2024.\u003c/p\u003e\u003cp\u003eParticipants who are eligible to take part based on their pre-assessment will be invited to take part in Phase 2 of the study which is attending the intervention group and the post-assessment (a brief assessment which contains some repeated measures from the pre-assessment). Young people and caregivers will be briefed on the intervention and asked to sign the consent and assent form. The intervention group composed of seven adolescent sessions and three caregiver sessions will be delivered on the school site during the school day by a member of the research team. Participants who do not attend sessions will receive the content in a catch up session over the phone or in person. Recruitment to the intervention will finish in January 2025. Phase 2 is scheduled to begin in January 2025 and finish by March 2025.\u003c/p\u003e\u003cp\u003eA sub-section of participants will be invited to take part in Phase 3 of the study which is qualitative interviews. School staff will also be invited to take part in Phase 3. This is to assess and gain insight into the feasibility and acceptability of the EASE group. Young people, caregivers and school staff will be briefed on this phase of the study and asked to sign the consent and assent form. Phase 3 is scheduled to begin in March 2025.\u003c/p\u003e\u003cp\u003eYoung people and caregivers will be briefed on the intervention and asked to sign the consent and assent form. The ideal group size for EASE is 8\u0026ndash;12 participants and so the aim is to recruit 10\u0026ndash;12 participants from each site.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eStudy intervention\u003c/h2\u003e\u003cp\u003eThe EASE intervention is aimed at 10\u0026ndash;15 year olds who have experienced adversity and who are affected by internalising distress such as sadness or worry. EASE is adapted from cognitive behavioural therapy and optimised for delivery by non-clinicians. The intervention aims to support young people and their caregivers with skills to reduce distress. These skills include identifying feelings, stress management, behavioural activation and problem solving as these have been identified as components of evidence-based treatments which are suitable to be adapted for non-clinician delivery. The intervention is designed to be adapted for different cultural contexts. This study will use a version of EASE adapted for a Welsh cultural background. The intervention will also be adapted for a younger age range of 9.5\u0026ndash;12 years as this is consistent with the Welsh education system and the age range covered by Year 5 and Year 6. The group size will be 8\u0026ndash;12 participants for both the young person group and the caregiver group. Participants will complete self-report measures on internalising distress. The EASE materials are freely available at \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.who.int/publications/i/item/9789240082755\u003c/span\u003e\u003cspan address=\"https://www.who.int/publications/i/item/9789240082755\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003eIntervention content\u003c/h2\u003e\u003cp\u003eAdolescent session 1: Understanding My Feelings\u003c/p\u003e\u003cp\u003eParticipants will receive an overview of the aims of EASE. Group rules will be set collaboratively, including the importance of confidentiality and when this cannot be adhered to. Participants will be introduced to the intervention materials including the Storybook. Participants will complete discussion, drawing and writing activities to support identifying how difficult feelings might arise in stressful situations and how to recognise their own feelings accurately. For home practice, participants will be asked to practice identifying which feelings they experience each day using the Feelings Pot worksheet. The session will end with an activity to identify participants\u0026rsquo; individual strengths. This will be repeated as a closing activity for all adolescent sessions.\u003c/p\u003e\u003cp\u003eAdolescent session 2: Calming My Body\u003c/p\u003e\u003cp\u003eThe session will begin with a review of the previous session and the associated home practice. Participants will be supported to review any previous aspects of the intervention which they did not understand and to manage any problems arising from completing the home practice. Participants will then learn about how feelings are experienced in the body as sensations, using a Body Map poster, before discussing possible helpful coping strategies for managing difficult feelings. Participants will identify the difference between helpful and unhelpful coping strategies. The Slow Breathing activity will be introduced as a potential helpful strategy for calming our bodies. Slow Breathing and the Body Map activity will be added as home practice activities.\u003c/p\u003e\u003cp\u003eAdolescent session 3: Changing My Actions 1\u003c/p\u003e\u003cp\u003eParticipants will review previous sessions and home practice to consolidate learning and deepen understanding of the skills. Participants will complete an activity using the Storybook and the Vicious Cycle poster to learn about how feelings can affect actions and behaviours, which can then contribute to maintaining the problem or can make difficult feelings worse. The Changing My Actions activity will be introduced as a way of using planning strategies to do meaningful things to help improve feelings. Changing My Actions will be introduced as a home practice activity alongside the home practice activities from previous weeks.\u003c/p\u003e\u003cp\u003eAdolescent session 4: Changing My Actions 2\u003c/p\u003e\u003cp\u003ePrevious skills will be reviewed, and participants will reflect on their experience of practicing Slow Breathing and Changing My Actions in home practice. Participants will learn more about how to gradually engage in activities to help improve mood. Participants will complete activities to support them with practicing Changing My Actions outside of the intervention sessions. Home practice of all the skills will be set again.\u003c/p\u003e\u003cp\u003eAdolescent session 5: Managing My Problems 1\u003c/p\u003e\u003cp\u003eAll previous skills will be reviewed, and participants will be supported through troubleshooting of any difficulties with home practice. Participants will complete a group discussion activity to introduce the idea of common problems which might be faced by adolescents and how participants can support each other to manage problems. Participants will complete the Managing My Problems group activity using the Stop, Think, Go poster, and then plan how to use this strategy for a personal problem. This will then be added to the home practice.\u003c/p\u003e\u003cp\u003eAdolescent session 6: Managing My Problems 2\u003c/p\u003e\u003cp\u003eParticipants will reflect on their experience of home practice and continue to develop their skills in problem management by applying the Stop, Think, Go framework to a new problem. Participants will be encouraged to support and learn from each other, and to feel empowered to use the intervention skills with greater independence. Participants will complete an activity in anticipation of the end of the intervention, reflecting on their feelings associated with finishing and using the skills they have learned to plan how to manage any difficult feelings which may arise.\u003c/p\u003e\u003cp\u003eAdolescent session 7: Brighter Futures\u003c/p\u003e\u003cp\u003eParticipants will review all intervention content, and use role play to support participants to think of new ideas for solving their problems. Participants will explore how to continue to use the skills which they have learned in the future. Participants will complete a craft activity to help them remember and consolidate the EASE skills. The session will end with a closing activity to celebrate participants\u0026rsquo; strengths and achievements in completing the intervention, and participants will receive certificates. Participants will share one positive thing about the EASE group and one goal they have for the future.\u003c/p\u003e\u003cp\u003eCaregiver session 1: Understanding Big Feelings\u003c/p\u003e\u003cp\u003eParticipants will receive an overview of the aims of EASE, including the aims and content of the adolescent sessions. Group rules will be set collaboratively, including the importance of confidentiality and when this cannot be adhered to. Participants will be introduced to the intervention materials and the adolescent sessions will be summarised, including the importance of home practice. Participants will complete discussion activities to learn the causes and signs of big feelings in adolescence, including the physical sensations big feelings may cause. Guidance will be provided around situations where adolescents make reference to ending their life and how to safely provide support in this situation. Participants will then complete a role play activity around how to soothe and use active listening when responding to big feelings. Participants will be given an explanation about the importance of quality time with a child and how to overcome barriers to quality time. The session will end with a slow breathing activity. For home practice, participants will be asked to practice active listening and spend quality time with their child before the next session.\u003c/p\u003e\u003cp\u003eCaregiver session 2: The Power of Praise\u003c/p\u003e\u003cp\u003eThe session will begin with a review of home practice. Participants will be supported to manage any problems arising from completing the home practice. Participants will then learn about the skills being taught to their child in the EASE adolescent group. Participants will complete a discussion activity reflecting on their child\u0026rsquo;s individual strengths. Participants will learn about the importance of giving and receiving praise and roleplay effective praise. Participants will learn about alternative approaches to behaviour management rather than using harsh punishment. The session will end with a summary and active listening and praise will be set as home practice\u003c/p\u003e\u003cp\u003eCaregiver session 3: Caregiver self-care and brighter futures\u003c/p\u003e\u003cp\u003eParticipants will review previous intervention content, reflect on their experience of home practice, and discuss how best to support their children with ongoing home practice. Participants will complete a discussion activity around identifying and celebrating their strengths. They will then learn about the importance of self-care and how to overcome barriers to self-care. Participants will receive an explanation of how they can keep supporting their child with their EASE skills. The session will end with a closing activity in which participants will share one positive thing about the EASE group and be encouraged to keep supporting each other and using the techniques they have learned. Participants will also be signposted to potential future sources of support which they or their child might need.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003eIntervention facilitators\u003c/h2\u003e\u003cp\u003eSessions will be conducted by a member of the research team (FA) who is a current PhD student and also an experienced teacher and safeguarding professional, with experience of delivering similar psychoeducational groups to adolescents. FA received EASE training from a chartered counselling psychologist and will access ongoing supervision from this psychologist throughout the intervention.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\u003ch2\u003eImplementation outcomes\u003c/h2\u003e\u003cp\u003eFeasibility\u003c/p\u003e\u003cp\u003eFeasibility measures the extent to which a new intervention can be successfully conducted in a specific context. This outcome will be measured by recruitment, retention and participation rates. It will also be assessed through coproduction workshops and qualitative feedback. The success of feasibility will be determined by a recruitment rate of at least 8 adolescents at each site and a retention and participation rate of at least 90%.\u003c/p\u003e\u003cp\u003eAcceptability\u003c/p\u003e\u003cp\u003eAcceptability will be assessed through post-intervention interviews with a sample of adolescents, caregivers and school staff who were involved in the programme. Interviews will take place in a private classroom or office on the school premises, or optionally over the phone or video call for adults. All participants will be invited to take part in the interviews. Following assent and parental/caregiver, approximately three adolescents and three caregivers will be invited to interview. A random stratified selection will be made to include both male and female participants. Interviews will be conducted by the programme facilitators. Interviews will be audio-recorded with permission from participants.\u003c/p\u003e\u003cp\u003eParticipant self-report measures\u003c/p\u003e\u003cp\u003eParticipants will complete self-report measures on internalising distress to check these measures are appropriate for a subsequent trial and to inform a power calculation for a subsequent trial. The measure will be the internalising problems subscale from the Paediatric Symptom Checklist (PSC-17). Demographic information including age and gender will also be collected at baseline assessment. Schools will provide an overview of the family background and the ACEs experienced by participants.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\u003ch2\u003eData analysis\u003c/h2\u003e\u003cp\u003eDemographics and feasibility outcomes will be summarised using descriptive statistics to explore recruitment, retention and participation rates. Quantitative data will be analysed using SPSS Statistics.\u003c/p\u003e\u003cp\u003eQualitative data from interviews will be transcribed verbatim and will be uploaded into NVivo to be analysed. Codes and subsequent themes will be deductively developed insofar as codes will be organised according to the question of to what extent the intervention is acceptable to participants.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eSchool-based interventions for young people affected by ACEs are a promising way to decrease distress, which could reduce the negative impact of ACEs in the long term. Around half of the population are estimated to have at least one ACE, and therefore this population is an important group to target.\u003c/p\u003e\u003cp\u003eThis study will be the first to trial EASE in a UK population. If this trial is successful, it would lead to a larger scale independent trial to investigate if the EASE intervention could be used in Wales to promote skills for young people living with adversity to mitigate the negative long-term outcomes associated with ACEs. This would improve the quality of life of this population and save health-related costs associated with ACEs in the long term. A review identified limited evidence for interventions suitable for delivery by school staff; there is a need to develop the evidence base for mental health interventions which are suitable for delivery by non-clinicians and which could help to mediate against the negative impact of ACEs (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe intervention reported in this protocol could be scaled up to a national level to reach many young people and families living in adversity. The coproduction and implementation considerations of this study are important features which would support a larger trial to address real-life implementation challenges and effectively scale up in a Welsh context.. Findings will be disseminated through a publication in a peer reviewed journal and by sharing accessible findings to a wider audience of stakeholders including schools and local authorities.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cul\u003e\n \u003cli\u003eAdverse Childhood Experiences (ACEs)\u003c/li\u003e\n \u003cli\u003eEASE (Early Adolescents Skills for Emotions)\u003c/li\u003e\n \u003cli\u003eWHO (World Health Organisation)\u003c/li\u003e\n \u003cli\u003ePaediatric Symptom Checklist (PSC-17)\u003c/li\u003e\n \u003cli\u003eAdditional Learning Need (ALN)\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Declarations","content":"\u003ch4\u003eEthics approval and consent to participate\u003c/h4\u003e\n\u003cp\u003eThe Swansea University Medical School Ethics Sub-Committee approved the study on 27 September 2024 (Research Ethics Approval Number: 4 2024 10283 10467). Young person assent and parental/caregiver consent will be sought for participation in the study; both are required for participation. Parent/caregivers will also give consent for their own participation in the study.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eConsent for publication\u003c/h4\u003e\n\u003cp\u003eAll participants provided consent for publication of anonymised data.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eAvailability of data and materials\u003c/h4\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003ch4\u003eCompeting interests\u003c/h4\u003e\n\u003cp\u003eThe authors declare that they have no competing interests\u003c/p\u003e\n\u003ch4\u003eFunding\u003c/h4\u003e\n\u003cp\u003ePublic Health Wales and ESRC provided funding for this research through their support of a PhD studentship (FA).\u003c/p\u003e\n\u003ch4\u003eAuthors' contributions\u003c/h4\u003e\n\u003cp\u003eFA is the corresponding author and was responsible for the conception and design of the project and will lead on analysis and interpretation of data. She is also responsible for the initial draft of this manuscript\u003c/p\u003e\n\u003cp\u003eSB provided supervisory oversight regarding the conception and design of the project and was responsible for securing funding, and also provided comments on drafts of this manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKH provided supervisory oversight regarding the conception and design of the project and provided comments on drafts of this manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLG provided comments on drafts of this manuscript.\u003c/p\u003e\n\u003ch4\u003eAcknowledgements\u003c/h4\u003e\n\u003cp\u003eMany thanks to Dr Jasminder Bahia for providing counselling supervision on this project and to Dr Michaela James for providing advice concerning coproduction activities.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eAnda RF, Felitti VJ, Bremner JD, Walker JD, Whitfield C, Perry BD, et al. The enduring effects of abuse and related adverse experiences in childhood. European Archives of Psychiatry and Clinical Neuroscience 2005 256:3 [Internet]. 2005 Nov 29 [cited 2023 Jun 16];256(3):174\u0026ndash;86. Available from: https://link.springer.com/article/10.1007/s00406-005-0624-4\u003c/li\u003e\n\u003cli\u003eBellis MA, Hughes K, Leckenby N, Hardcastle KA, Perkins C, Lowey H. Measuring mortality and the burden of adult disease associated with adverse childhood experiences in England: A national survey. Journal of Public Health (United Kingdom). 2015 Sep 1;37(3):445\u0026ndash;54. \u003c/li\u003e\n\u003cli\u003eBellis MA, Hughes K, Ford K, Ramos Rodriguez G, Sethi D, Passmore J. Life course health consequences and associated annual costs of adverse childhood experiences across Europe and North America: a systematic review and meta-analysis. Lancet Public Health [Internet]. 2019 Oct 1 [cited 2024 Feb 9];4(10):e517. Available from: /pmc/articles/PMC7098477/\u003c/li\u003e\n\u003cli\u003eHoover S, Bostic J. Schools as a vital component of the child and adolescent mental health system. Psychiatric Services [Internet]. 2021 Jan 1 [cited 2024 May 22];72(1):37\u0026ndash;48. Available from: https://ps.psychiatryonline.org/doi/10.1176/appi.ps.201900575\u003c/li\u003e\n\u003cli\u003eAvery F, James M, Cowley LE, Griffiths L, Bellis MA, Hughes K, et al. \u0026ldquo;Support for my dad would have benefited me because I was the one looking after him\u0026rdquo;: A qualitative analysis of the support needs of young people exposed to Adverse Childhood Experiences. medRxiv [Internet]. 2024 Oct 28 [cited 2024 Dec 5];2024.10.25.24316104. Available from: https://www.medrxiv.org/content/10.1101/2024.10.25.24316104v1\u003c/li\u003e\n\u003cli\u003eAvery F, Kennedy N, James M, Jones H, Amos R, Bellis M, et al. A systematic review of non-clinician trauma-based interventions for school-age youth. PLoS One [Internet]. 2024 Sep 1 [cited 2024 Sep 27];19(9):e0293248. Available from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0293248\u003c/li\u003e\n\u003cli\u003eBryant RA, Malik A, Aqel IS, Ghatasheh M, Habashneh R, Dawson KS, et al. Effectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial. PLoS Med. 2022 Aug 1;19(8). \u003c/li\u003e\n\u003cli\u003eMellor K, Albury C, Dutton SJ, Eldridge S, Hopewell S. Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud [Internet]. 2023 Dec 1 [cited 2025 Feb 3];9(1):1\u0026ndash;10. Available from: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01291-5\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Adverse Childhood Experiences, mental health, wellbeing, intervention, behavioural activation, group intervention, family support, adolescents","lastPublishedDoi":"10.21203/rs.3.rs-5671004/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5671004/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground\u003c/p\u003e\n\u003cp\u003eAdverse Childhood Experiences (ACEs) are potentially traumatic experiences occurring before the age of 18, such as experiencing child maltreatment, or living with a person with a mental health condition. Young people exposed to ACEs face an increased risk of health problems both at time of exposure and after the experience.\u003c/p\u003e\n\u003cp\u003eEarly intervention to develop emotional coping skills for those living through adverse experiences can be beneficial. The EASE (Early Adolescents Skills for Emotions) is a group intervention for young people who have experienced adversity, suitable for delivery by non-clinicians such as teachers. This study will report an implementation protocol for assessing the feasibility, retention and acceptability of the EASE intervention in order to inform the development of a larger efficacy trial.\u003c/p\u003e\n\u003cp\u003eMethods\u003c/p\u003e\n\u003cp\u003eThis study is a single-arm, open-label, pilot trial. A total of 20 children and their caregivers will be recruited from two school sites. Participants will attend a seven-session group intervention which includes elements of mindfulness and behaviour activation. Participants’ caregivers also attend three concurrent sessions. To assess feasibility, we will examine recruitment, retention and participation rates: Can 16-20 families in 2 schools be recruited, and do 14 remain to the end with 50% or more of sessions attended? Participants will also complete a measure of internalising distress at baseline and post-intervention, with no long-term follow up. Acceptability will be evaluated through qualitative interviews post-intervention.\u003c/p\u003e\n\u003cp\u003eDiscussion\u003c/p\u003e\n\u003cp\u003eThis study will establish the feasibility of a novel intervention aimed at promoting coping strategies and reducing internalising distress amongst young people who have experienced ACEs. The EASE intervention will be modified through stakeholder feedback and optimised for the Welsh context. Evidence from this study will be useful to families, school staff and healthcare professionals in supporting adolescent mental health and will serve as a model for a future trial to examine efficacy of the proposed intervention.\u003c/p\u003e\n\u003cp\u003eISRCTN study registration number: ISRCTN91291368.\u003c/p\u003e","manuscriptTitle":"The implementation of a school-based face to face group intervention for young people with Adverse Childhood Experiences in Wales: a feasibility study protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-08 09:53:14","doi":"10.21203/rs.3.rs-5671004/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewersInvited","content":"","date":"2025-08-21T14:21:36+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2025-02-07T06:04:26+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d413d016-79d7-4290-8ac0-a4da3a06d5e8","owner":[],"postedDate":"September 8th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-09-08T09:53:14+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-08 09:53:14","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5671004","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5671004","identity":"rs-5671004","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}