Abstract

BackgroundAnxiety in children is common and incapacitating and increases the risk of mental health disorders in adulthood. Although effective interventions are available, few children are identified and referred for specialist treatment. Alternative approaches in which prevention programmes are delivered in school appear promising. However, comparatively little is known about the best intervention leader (health care–led vs. school-led), long-term effects or the primary preventive value of such programmes.Methods/DesignPreventing Anxiety in Children through Education in Schools, or PACES, is a pragmatic cluster randomised controlled trial evaluating the effectiveness of a cognitive-behavioural therapy prevention programme (FRIENDS) on symptoms of anxiety and low mood in 9- to 10-year-old children. Forty-one schools were randomly assigned to one of three conditions: school-led FRIENDS, health care–led FRIENDS or treatment as usual. Assessments were undertaken at baseline, 6 months and 12 months, with the primary outcome measure being the Revised Child Anxiety and Depression Scale score at 12 months. Secondary outcome measures are changes in self-esteem, worries, bullying and life satisfaction.DiscussionThis protocol summarises the procedure for the 24-month follow-up of this cohort. The study will determine the medium-term effectiveness of an anxiety prevention programme delivered in schools.Trial registrationISRCTN23563048

Highlights

  • Anxiety in children is common and incapacitating and increases the risk of mental health disorders in adulthood

  • The study will determine the medium-term effectiveness of an anxiety prevention programme delivered in schools

  • The investigators in the American Great Smoky Mountains Study found that, during a 3-month period, 2.4% of children ages 9 to 16 years fulfilled the diagnostic criteria for an anxiety disorder and 2.2% met the criteria for a depressive disorder [1]

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Summary

Background

Anxiety and depressive disorders in children are common. The investigators in the American Great Smoky Mountains Study found that, during a 3-month period, 2.4% of children ages 9 to 16 years fulfilled the diagnostic criteria for an anxiety disorder and 2.2% met the criteria for a depressive disorder [1]. The primary outcome for our long-term follow-up is the Revised Child Anxiety and Depression 30-item Scale (RCADS-30) score assessed at 24 months [29]. To take appropriate account of the hierarchical nature of the data, we will use multivariable mixed-effects regression to compare mean RCADS-30 scores at 24 months for health care–led FRIENDS versus school-led FRIENDS versus usual school provision of PSHE, with adjustments made for baseline RCADS-30 scores and randomisation variables. These analyses will be repeated for secondary outcomes. We will undertake a secondary analysis using interaction terms in the regression model to explore differences at 24 months between randomised arms and the baseline variable (RCADS scores of 0 to (low anxiety) and and higher (high anxiety))

Discussion
21. Mrazek PJ
24. Stallard P
27. Department for Education and Skills: Excellence and Enjoyment
32. Rosenberg M
37. Goodman R
Findings
40. Stevens K
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