Dataset Information

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).

ABSTRACT:

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.

SUBMITTER: Ball S

PROVIDER: S-EPMC10795300 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Publications

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).

Ball Susan S Reardon Tessa T Creswell Cathy C Taylor Lucy L Brown Paul P Ford Tamsin T Gray Alastair A Hill Claire C Jasper Bec B Larkin Michael M Macdonald Ian I Morgan Fran F Pollard Jack J Sancho Michelle M Sniehotta Falko F FF Spence Susan H SH Stainer Jason J Stallard Paul P Violato Mara M Ukoumunne Obioha C OC

Trials 20240117 1

<h4>Background</h4>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 chil ...[more]

PMID: 38233861

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Project description:BackgroundSystematically 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.DiscussionThis 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 registrationISRCTN registry ISRCTN76119074. Prospectively registered on 4.1.2022.

Project description:BackgroundAnxiety 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.MethodsWe 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.DiscussionEvidence-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 registrationISRCTN registry: ISRCTN30032471 . Retrospectively registered on 18 May 2021.

Project description:BackgroundIn the context of COVID-19, NHS Child and Adolescent Mental Health Services (CAMHS) and other children's mental health services have faced major challenges in providing psychological treatments that (i) work when delivered remotely and (ii) can be delivered efficiently to manage increases in referrals as social distancing measures have been relaxed. Anxiety problems are a common reason for referral to CAMHS, children with pre-existing anxiety problems are particularly vulnerable in the context of COVID-19, and there were concerns about increases in childhood anxiety as schools reopened. The proposed research will evaluate the clinical and cost-effectiveness of a brief online parent-led cognitive behavioural treatment (CBT) delivered by the OSI (Online Support and Intervention for child anxiety) platform with remote support from a CAMHS therapist compared to 'COVID-19 treatment as usual' (C-TAU) in CAMHS and other children's mental health services throughout the COVID-19 pandemic.MethodsWe will conduct a two-arm, multi-site, randomised controlled non-inferiority trial to evaluate the clinical and cost-effectiveness of OSI with therapist support compared to CAMHS and other child mental health services 'COVID-19 treatment as usual' (C-TAU) during the COVID-19 outbreak and to explore parent and therapists' experiences.DiscussionIf non-inferiority is shown, the research will provide (1) a solution for efficient psychological treatment for child anxiety disorders while social distancing (for the COVID-19 context and future pandemics); (2) an efficient means of treatment delivery as 'normal service' resumes to enable CAMHS to cope with the anticipated increase in referrals; and (3) a demonstration of rapid, high-quality evaluation and application of online interventions within NHS CAMHS to drive forward much-needed further digital innovation and evaluation in CAMHS settings. The primary beneficiaries will be children with anxiety disorders and their families, NHS CAMHS teams, and commissioners who will access a potentially effective, cost-effective, and efficient treatment for child anxiety problems.Trial registrationISRCTN ISRCTN12890382 . Registered prospectively on 23 October 2020.

Project description:BackgroundInternet-based treatments for child anxiety may help to increase access to evidence-based therapies; however, user engagement, uptake, and adherence within routine clinical practice remain as challenges. Involving the intended end users in the development process through user-centered design and usability testing is crucial for maximizing user engagement and adoption of internet-based treatments, but so far this has been lacking for internet-based treatments for child anxiety.ObjectiveThe aim of this study is to develop an internet-based treatment for child anxiety through a process of user-centered design (phase 1) and usability testing (phase 2), based on an existing evidence-based, face-to-face, therapist-supported, parent-led cognitive behavioral therapy intervention. It is intended that the internet-based version of this treatment would consist of a parent website, case management system for clinicians, and mobile game app for children.MethodsParents, children, and clinicians who were familiar with the face-to-face version of the treatment were recruited from 2 National Health Service clinics. In phase 1, participants participated in 3 workshops to gain feedback on the overall concept, explore their wants and needs for the websites and game, generate ideas on how the treatment may look, and gain feedback on initial mock-ups of the websites and game. In phase 2, participants attended 3 individual usability testing sessions where they were presented with working prototypes of the website or game and asked to perform a series of tasks on the website (parents and clinicians) or play the game (children). The frequency and details on usability errors were recorded. Participants were asked for their feedback on the website and game using a standardized usability questionnaire and semistructured interviews. The websites and game were iterated after each round of usability testing in response to this feedback.ResultsIn phase 1, participants approved the general concept and rated the initial mock-ups of the website and game positively. In phase 2, working prototypes were rated positively and usability errors declined across the iterations and were mainly cosmetic or minor issues relating to esthetic preference, with few issues regarding ability to navigate the website or technical issues affecting functionality. Feedback from the semistructured interviews further supported the positive response of participants to the website and game, and helped identify areas for improvement during the iteration process. The final iteration of the website and game are presented.ConclusionsTaking an iterative approach to development through user-centered design and usability testing has resulted in an internet-based treatment for child anxiety (Online Support and Intervention for child anxiety) that appears to meet the needs and expectations of the intended users (parents, children, and clinicians) and is easy and enjoyable to use.

Dataset Information

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

Methods and design

Trial registration

Publications

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).

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