Title: A randomised feasibility study of a school-based emotional literacy programme (Zippy's Friends) for children with intellectual disabilities
Funder: Department of Health and Social Care

Abstract: Why this is important:_x000D_ Children with intellectual disability (ID) have difficulties with learning and coping on their own. They need help with everyday tasks and because of their disability they can become easily stressed and upset and develop long-term mental health problems. Guidelines that have been published recently for people with ID and mental health needs stress the importance of emotional literacy (the ability to understand, express and manage your own feelings) for mental health but as yet there are no suitable evidence-based programmes to teach emotional literacy to children with ID attending schools for children with special educational needs and disabilities (SEND). _x000D_ _x000D_ The intervention: _x000D_ Zippy’s Friends (ZF) is a programme that is already used widely (and is shown to be effective) in mainstream schools. Our team has adapted ZF so that it can be taught to 9-11 year old children in SEND schools. ZF is designed to help them deal with social and emotional problems and teach skills to help them cope better with and prevent mental health problems. Parents are sent materials that can be used to prompt the children to use the skills they have learned at school in their own home. _x000D_ _x000D_ The research plan: _x000D_ We plan to include 12 SEND schools/units in our study. Six schools will be asked to use ZF in at least one of their classes over a school year and at least 2 classroom teachers per school will be trained and supported to run the ZF programme. Six schools will provide their standard teaching programmes only; they are called the control group. To allow for a fair test of whether the ZF programme works, chance (rather than researchers or school staff) will decide which schools are put into ZF or the control group. Teachers, parents and children of all the schools will be asked to fill in questionnaires to measure any resulting changes. The most important of these focus on the mental health and behaviour of the children. Other questionnaires are designed to pick up changes in the children’s social skills, emotional literacy, quality of life and how they use health, social and education services. _x000D_ _x000D_ This will be a feasibility study to determine the willingness of schools to take part in ZF or to be in the control group, if ZF is delivered as planned, and if the questionnaires are suitable for measuring the effectiveness of ZF. We will also interview some of the teachers, parents and children and ask them about what encouraged them to take part in the research, and what got in the way of this and about positive and difficult experiences of ZF. _x000D_ _x000D_ Our advisors: _x000D_ We have worked closely with a charitable organisation called Partnership for Children which created ZF for special schools and has experience of training teachers in delivering ZF in their classrooms. They have worked with many schools to make ZF part of the school culture. They will deliver the ZF programme to the schools and train the teachers. NASEN, a charity that promotes the advancement and development of individuals with SEND, will work closely with parent organisations and, as one of the lead organisations of Whole School SEND, will chair our PPI Advisory group to make sure that the research stays relevant and that the results reach the relevant people - policy makers and managers, teachers and families. The British Institute for Learning Disabilities (BILD) has agreed to be on the PPI Advisory Group and the Study Steering Committee.

Lay abstract: Overall aim: To determine feasibility of the ZF SEND programme, which aims to improve social and emotional functioning of children with ID and equip them with adaptive coping strategies and resilience to prevent/address mental health problems._x000D_ Design: A cluster randomised feasibility study (schools randomised to intervention or comparator with all pupils within a school receiving the same allocation). Economic scoping study, process evaluation, and study within a trial (SWAT) exploring preference for “waitlist” comparator design._x000D_ Setting: Participating SEND schools (6 intervention and 6 control)._x000D_ Population: Children with ID aged 9-11years attending SEND schools in England and Scotland. Approx. N=8 per school (approx. total pupils = 96)_x000D_ Inclusion: Administratively defined with ID (learning disability/difficulty in UK services terminology) by virtue of attending a SEND school/unit in England or Scotland._x000D_ Exclusion: No parental consent to participate in the research. Unable to assent to self-report MAMS assessment or to communicate using English._x000D_ Intervention: ZF is a manualised, educational, mental health-promotion package (six modules). ZF SEND programme closely aligns with the mainstream programme but has additional resources to make the programme accessible to children with ID. With bi-weekly 1-hour sessions, the programme can be delivered over one academic year._x000D_ Comparator: Usual practice (UP) excluding specific emotional literacy programmes. Half of schools will be approached (at random) with the offer of delayed access to ZF SEND._x000D_ Measures: Strengths and Difficulties Questionnaire (SDQ) is the primary outcome measure. Other outcome measures: Me and My School (MAMS), a self-report measure for young children of mental health; Emotional Literacy Assessment and Intervention (EL), a proxy report measure (teachers and parents);The Nisonger Child Behavior Rating Form (teacher version). Measures for economic evaluation to include: Quality of Life for children measured using the EQ5D-Y and the CHU-9D; Service Use as reported by parents using a modified version of the Child and Adolescent Service Use Schedule (CASUS)._x000D_ Analyses: Primarily descriptive analysis, with feasibility outcomes estimated with 95% confidence intervals. No formal hypothesis testing to take place. Exploratory analysis of outcome measures to be used in the main trial will involve multilevel linear regression models, with pupils nested within schools. Findings to be reported and to inform study design modifications required for a main trial. _x000D_ Process evaluation: Using recent MRC guidance as a framework, an embedded process evaluation will assess (i) recruitment and retention (ii) attendance (iii) fidelity of delivery (iv) adverse effects (reported by teachers) (v) engagement in the intervention, barriers and facilitators to delivery (teacher interviews n=6) and exploration of UP for teachers in control arm (n=6) and (vi) parent/child satisfaction with the intervention. Interviews with pupils (n=12) and parents (n=12) will explore intervention receipt and the acceptability and perceived value of ZF SEND. Thematic analysis will be used to analyse each of the sub-sets of interviews (class teachers, pupils, parents/carers) separately and independently. A triangulation exercise to be conducted combining the qualitative results with the quantitative results, including an assessment of barriers and facilitating factors to recruitment, fidelity and intervention.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH