A randomised controlled cluster trial comparing the effectiveness and cost effectiveness of a school based cognitive behaviour therapy programme (FRIENDS) in the reduction of anxiety and improvement in mood in children aged 9/10

DESIGN: Randomised controlled cluster trial comparing FRIENDS (delivered by health professional or school) vs. treatment as usual for the reduction and prevention of anxiety symptoms and low mood (i.e. reduced symptoms of depression) in children aged 9/10. SETTING: 45-54 junior schools in Bath and North East Somerset and Wiltshire. INTERVENTION BEING EVALUATED: FRIENDS is a manualised cognitive behaviour therapy (CBT) programme designed to improve children's mental health. Each child has a workbook and group leaders a comprehensive manual detailing the content and structure of each session. FRIENDS involves 10, 60-minute weekly sessions delivered to whole classes as part of the school PSHE programme. FRIENDS teaches children practical skills to identify their feelings; to learn to relax; to identify unhelpful thoughts and to replace them with more helpful thoughts; and how to face and overcome their problems and challenges. Initial training and regular supervision of leaders will be provided by a specialist CBT expert. An additional session for parents/carers is provided at the start of FRIENDS to provide an overview of the programme, the CBT rationale and the skills the children will be taught. Parents will receive a sheet at the end of each session summarising what the children have discussed and the ideas they will be practicing each week so that they can reinforce and encourage their use at home. MEASUREMENT OF OUTCOMES AND DURATION OF FOLLOW-UP: (a). Psychological functioning: The primary outcomes will be reduced levels of anxiety and improved mood (i.e. reduced symptoms of depression) as assessed on continuous measures at 6 & 12 months. Secondary outcomes are improved self-esteem, and reductions in bullying. Assessments at 3 different times: • Time 1, baseline; • Time 2, post FRIENDS (6 months); • Time 3, 12 month. Parents will complete a behavioural screening questionnaire at all 3 time points. (b). Acceptability: Children will rate FRIENDS on 10 dimensions e.g. enjoyment, acquisition and use of new skills, etc. (c). Delivery: Leaders will assess FRIENDS on factors such as child engagement, school support, etc. (d). Treatment fidelity will be assessed by observing a random selection of 10% of FRIENDS sessions and assessing whether learning points and exercises were covered. (e). Parent Interviews at baseline and 6 months: For the economic evaluation, a purposeful sample of carers/parents of 300 children, 100 from each condition, will complete the Client Receipt of Services Questionnaire about their child’s use of health, social and educational services. Qualitative interviews with 20 parents from the FRIENDS group to assess how and why the intervention might benefit children e.g. changes in friendships; family relationships; educational progress and engagement in out of school social and recreational activity. (f). Cost and cost-effectiveness: an analysis comparing the two versions of FRIENDS vs. treatment as usual. The cost-effectiveness analysis will be based on the primary outcome measures. Both the cost analysis and the cost-effectiveness analysis will be from the joint perspective of the health (NHS) and education/social services sector. The research will identify, measure and value the resource consequences of each alternative (applying opportunity cost as the main principle for valuation. PLANNED ANALYSIS: Analysis and presentation of data will be in accordance with CONSORT guidelines. The primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals for the between-arm comparisons. Descriptive student- and class-level statistics will be used to ascertain any marked imbalance between the arms at baseline. The primary analysis will employ a mixed effect linear regression model to compare the active CBT interventions versus treatment as usual, adjusting for stratification variables and baseline score, a