Cluster‐randomised controlled trial of an occupational therapy intervention for children aged 11–13 years, designed to increase participation to prevent symptoms of mental illness

Abstract

Background The impact of occupational therapy on mental health outcomes for children is largely unexplored. The aim of this study was to investigate an evidence‐based occupational therapy intervention designed to increase participation in daily occupations to prevent symptoms of mental illness for children and run in schools. Methods The study used a pragmatic, cluster‐randomised controlled trial design with two arms. Fourteen clusters (schools), equating to 151 child participants, were stratified by school decile‐rank category and block randomised. Blinding of participants post‐randomisation was not feasible; however, outcomes assessors were blinded. Outcomes were measured at baseline, after the parallel and crossover phases, and at follow‐up; and were anxiety symptoms (primary), depression symptoms, self‐esteem, participation and wellbeing. Intention‐to‐treat analysis was applied and mixed linear modelling was used to account for clusters and repeated measures, and to adjust for covariates identified. Results This trial found significant positive effects of the intervention on child‐rated satisfaction with their occupational performance and teacher‐rated child anxiety. No evidence was found to support the effect of the intervention on anxiety and depression symptoms, self‐esteem and wellbeing. Conclusions This was the first known cluster‐randomised controlled trial to investigate an occupational therapy intervention promoting emotional wellbeing in a non‐clinical sample of children. No compelling evidence was found to support the use of the intervention in schools in its current format, however, results were promising that the focus on occupations influenced participation. Recommendations are made to redesign the intervention as an embedded intervention in the classroom, cotaught by teachers and including parental involvement.

School-based interventions to prevent anxiety, depression and conduct disorder in children and young people: a systematic review and network meta-analysis

“…Eleven studies (n = 1314) contributed to the analysis for the post-intervention time point. 115,116,[174][175][176][177][178][179][180][181][182] Three studies were deemed to be at low risk of bias and six studies were deemed to be at unclear risk of bias for both the randomisation and allocation concealment domains. A further two studies were rated as having an unclear risk of bias for allocation concealment, but a low risk of bias for random sequence generation.…”

“…Five studies (497 participants) contributed to the analysis for the post-intervention time point, of which four included an intervention based on CBT, and one examined an occupational therapy-based intervention. 175,[179][180][181]232 One study was deemed to be at low risk of bias for both random sequence generation and allocation concealment, and three studies were deemed to be at unclear risk of bias. One study was deemed to be at low risk of bias for random sequence generation but at unclear risk of bias for allocation concealment.…”

“…Of the 137 studies focused on preventing anxiety, depression, or both depression and anxiety, 15 reported an outcome of self-reported psychological well-being, life satisfaction or quality of life. Five studies reported measuring well-being using the Warwick-Edinburgh Mental Wellbeing Scale, 124,126,127,132,133 seven studies reported a measure of life satisfaction 124,131,159,181,187,203,239 and two studies reported a quality-of-life measure. 129,235 One study reported a measure of social functioning 206 and one used the Ryff Scales of Psychological Well-being.…”

“…Six studies 115,116,176,177,181,182 provided both baseline and follow-up data to enable a NMA for targeted primary settings. There was no evidence that CBT-based interventions (SMD -0.43, 95% CrI -1.08 to 0.14), biofeedback (SMD -0.48, 95% CrI -1.76 to 0.72) or occupational therapy (SMD 0.05, 95% CrI -1.07 to 1.19) reduced parent-reported child anxiety symptoms relative to a waiting list.…”

Advancing cluster randomised trials in children’s therapy: a survey of the acceptability of trial behaviours to therapists and parents

“…Whilst recognising the challenge to children’s therapy trials, it is also important to note that large-scale children’s therapy trials have been successfully conducted across several contexts, such as school-based practice [ 29 , 51 , 52 ] and sensory integration [ 3 ]. Their success suggests trials are possible in children’s therapy at least some of the time.…”