Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i).

BACKGROUND: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether 'screening and intervention', consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only - 'usual school practice', for children aged 8-9 years in the following: (1) the 'target population', who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire - iCATS-2, and (2) the 'total population', comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. METHODS AND DESIGN: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022.

Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i): protocol for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice.

BACKGROUND: Systematically screening for child anxiety problems, and offering and delivering a brief, evidence-based intervention for children who are identified as likely to benefit would minimise common barriers that families experience in accessing treatment. We have developed a short parent-report child anxiety screening questionnaire, and procedures for administering screening questionnaires, sharing screening outcomes with families, and offering and delivering a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety) through schools. This trial aims to evaluate clinical and health economic outcomes for (1) children (aged 8-9) who screen positive for anxiety problems at baseline (target population) and (2) the wider population of all children in participating classes (total population) in schools randomly allocated to receive identification-to-intervention procedures and usual school practice ('screening and intervention'), compared to assessment and usual school practice only ('usual school practice').  METHODS: The trial design is a parallel-group, superiority cluster randomised controlled trial, with schools (clusters) randomised to 'screening and intervention' or 'usual school practice' arms in a 1:1 ratio stratified according to the level of deprivation within the school. We will recruit schools and participants in two phases (a pilot phase (Phase 1) and Phase 2), with progression criteria assessed prior to progressing to Phase 2. In total, the trial will recruit 80 primary/junior schools in England, and 398 children (199 per arm) who screen positive for anxiety problems at baseline (target population). In schools allocated to 'screening and intervention': (1) parents/carers will complete a brief parent-report child anxiety screening questionnaire (at baseline) and receive feedback on their child's screening outcomes (after randomisation), (2) classes will receive a lesson on managing fears and worries and staff will be provided with information about the intervention and (3) parents/carers of children who screen positive for anxiety problems (target population) will be offered OSI. OSI will also be available for any other parents/carers of children in participating classes (total population) who request it. We will collect child-, parent- and teacher-report measures for the target population and total population at baseline (before randomisation), 4 months, 12 months and 24 months post-randomisation. The primary outcome will be the proportion of children who screen positive for anxiety problems at baseline (target population) who screen negative for anxiety problems 12 months post-randomisation. DISCUSSION: This trial will establish if systematic screening for child anxiety problems, sharing screening outcomes with families and delivering a brief parent-led online intervention through schools is effective and cost-effective. TRIAL REGISTRATION: ISRCTN registry ISRCTN76119074. Prospectively registered on 4.1.2022.

Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i): protocol for single-arm feasibility trial.

BACKGROUND: Anxiety disorders are common among primary-school aged children, but few affected children receive evidence-based treatment. Identifying and supporting children who experience anxiety problems through schools would address substantial treatment access barriers that families and school staff often face. We have worked with families and school staff to co-design procedures that incorporate screening, feedback for parents, and the offer of a brief intervention in primary schools. This study sets out to assess the feasibility of a subsequent school-based cluster randomised controlled trial to evaluate these procedures. Our objectives are to ensure our procedures for identifying and supporting children with anxiety difficulties through primary schools are acceptable and there are no negative impacts, to estimate recruitment and retention rates, and to identify any changes needed to study procedures or measures. METHODS: We will recruit six primary/junior schools in England (2 classes per school), and invite all children (aged 8-9) (n = 360) and their parent/carer and class teacher in participating classes to take part. Children, parents and class teachers will complete questionnaires at baseline and 12-week follow-up. Children who 'screen positive' on a 2-item parent-report child anxiety screen at baseline will be the target population (expected n = 43). Parents receive feedback on screening questionnaire responses, and where the child screens positive the family is offered support (OSI: Online Support and Intervention for child anxiety). OSI is a brief, parent-led online intervention, supported by short telephone sessions with a Children's Wellbeing Practitioner. Participants' experiences of study procedures will be assessed through qualitative interviews/discussion groups. DISCUSSION: Evidence-based procedures for identifying and supporting children with anxiety difficulties through primary schools would improve children's access to timely, effective intervention for anxiety difficulties. TRIAL REGISTRATION: ISRCTN registry: ISRCTN30032471 . Retrospectively registered on 18 May 2021.

School-based screening for childhood anxiety problems and intervention delivery: a codesign approach.

OBJECTIVES: A very small proportion of children with anxiety problems receive evidence-based treatment. Barriers to access include difficulties with problem identification, concerns about stigma and a lack of clarity about how to access specialist services and their limited availability. A school-based programme that integrates screening to identify those children who are most likely to be experiencing anxiety problems with the offer of intervention has the potential to overcome many of these barriers. This article is a process-based account of how we used codesign to develop a primary school-based screening and intervention programme for child anxiety problems. DESIGN: Codesign. SETTING: UK primary schools. PARTICIPANTS: Data were collected from year 4 children (aged 8-9 years), parents, school staff and mental health practitioners. RESULTS: We report how the developed programme was experienced and perceived by a range of users, including parents, children, school staff and mental health practitioners, as well as how the programme was adapted following user feedback. CONCLUSIONS: We reflect on the mitigation techniques we employed, the lessons learnt from the codesign process and give recommendations that may inform the development and implementation of future school-based screening and intervention programmes.

Codesign and development of a primary school based pathway for child anxiety screening and intervention delivery: a protocol, mixed-methods feasibility study.

INTRODUCTION: Anxiety difficulties are among the most common mental health problems in childhood. Despite this, few children access evidence-based interventions, and school may be an ideal setting to improve children's access to treatment. This article describes the design, methods and expected data collection of the Identifying Child Anxiety Through Schools - Identification to Intervention (iCATS i2i) study, which aims to develop acceptable school-based procedures to identify and support child anxiety difficulties. METHODS AND ANALYSIS: iCATS i2i will use a mixed-methods approach to codesign and deliver a set of procedures-or 'pathway'-to improve access to evidence-based intervention for child anxiety difficulties through primary schools in England. The study will consist of four stages, initially involving in-depth interviews with parents, children, school staff and stakeholders (stage 1) to inform the development of the pathway. The pathway will then be administered in two primary schools, including screening, feedback to parents and the offer of treatment where indicated (stage 2), with participating children, parents and school staff invited to provide feedback on their experience (stages 3 and 4). Data will be analysed using Template Analysis. ETHICS AND DISSEMINATION: The iCATS i2i study was approved by the University of Oxford's Research Ethics Committee (REF R64620/RE001). It is expected that this codesign study will lead on to a future feasibility study and, if indicated, a randomised controlled trial. The findings will be disseminated in several ways, including via lay summary report, publication in academic journals and presentation at conferences. By providing information on child, parent, school staff and other stakeholder's experiences, we anticipate that the findings will inform the development of an acceptable evidence-based pathway for identification and intervention for children with anxiety difficulties in primary schools and may also inform broader approaches to screening for and treating youth mental health problems outside of clinics.