Abstract
BackgroundIdentifying and supporting young children who are at risk of developing anxiety disorders would benefit children, families, and wider society. Elevated anxiety symptoms, inhibited temperament, and high parental anxiety are established risk factors for later anxiety disorders, but it remains unclear who is most likely to benefit from prevention and early intervention programmes. Delivering an online intervention through schools to parents of young children who have one or more of these risks could maximise reach. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of delivering an online parent-led intervention, compared with usual school provision only, for children (aged 4–7) identified as at risk for anxiety disorders on the basis of at least one risk factor. We also aim to identify the characteristics of children who do and do not benefit from intervention and mechanisms of change from the intervention.MethodsThe design will be a parallel group, superiority cluster randomised controlled trial, with schools (clusters) randomised to intervention or usual school practice arms in a 1:1 ratio stratified according to level of deprivation within the school. The study will recruit and randomise at least 60 primary/infant schools in England, and on the basis of recruiting 60 schools, we will recruit 1080 trial participants (540 per arm). Parents of all children (aged 4–7) in sampled Reception, Year 1, and Year 2 classes will be invited to complete screening questionnaires. Children who screen positive on the basis of anxiety symptoms, and/or behavioural inhibition, and/or parent anxiety symptoms will be eligible for the trial. Parents/carers of children in schools allocated to the intervention arm will be offered a brief online intervention; schools in both arms will continue to provide any usual support for children and parents throughout the trial. Assessments will be completed at screening, baseline (before randomisation), 6 weeks, 12 weeks, and 12 months post-randomisation. The primary outcome will be the absence/presence of an anxiety disorder diagnosis at 12 months.DiscussionThe trial will determine if delivering an online intervention for parents of young children at risk of anxiety disorders identified through screening in schools is effective and cost-effective.Trial registrationISRCTN 82398107. Prospectively registered on Jan. 14, 2021.
Highlights
MethodsThe design will be a parallel group, superiority cluster randomised controlled trial, with schools (clusters) randomised to intervention or usual school practice arms in a 1:1 ratio stratified according to level of deprivation within the school
Identifying and supporting young children who are at risk of developing anxiety disorders would benefit children, families, and wider society
The trial will determine if delivering an online intervention for parents of young children at risk of anxiety disorders identified through screening in schools is effective and cost-effective
Summary
Study design The study will use a parallel group, superiority cluster randomised controlled trial design, with schools (clusters) randomised to the intervention or usual school practice arm in a 1:1 ratio stratified according to level of deprivation within the school. Mediators of primary outcome The following potential mediators of the absence/presence of an anxiety disorder at 12- months will be assessed at 6 weeks and 12 weeks post-randomisation: Risk factors (child anxiety symptoms, behavioural inhibition, parent anxiety symptoms) measured using PAS, STSC-A, and GAD-7 total scores. Items designed to assess a child’s tendency to avoid anxiety-provoking situations are rated on a 4-point scale (0 = never, almost never, or not an issue to 3 = almost always) and summed to provide a total score (range 0–24) which display good psychometric properties among primary-school aged children [52]. At baseline and 12 week assessments, parents will be provided with a diary to keep a record of time off school/work and use of services throughout the study duration to facilitate completing subsequent CSRIs. To identify and measure resources used in the intervention and screening, we will use “ad hoc” designed therapist, supervisor, and school staff logs. We will provide schools and participants with a report of study findings, and anonymised study data will be placed in a University repository for reuse by researchers
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
