Cluster-randomised controlled trial of an occupational therapy group intervention for children designed to promote emotional wellbeing: study protocol

Abstract

BackgroundSymptoms of anxiety and depression are common in childhood, as are risk factors that undermine wellbeing: low self-esteem and limited participation in daily occupations. Current treatments focus primarily on modifying internal cognitions with insufficient effect on functional outcomes. Occupational therapists have a role in measuring and enabling children’s functional abilities to promote health and wellbeing. To-date there is no evidence for the use of occupational therapy as an intervention to promote mental health or increase self-esteem, participation and wellbeing in a preventative context. The aim of this cluster-randomised controlled study is to investigate the effectiveness of an 8-week occupational therapy group intervention (Kia Piki te Hauora) at reducing symptoms of anxiety and depression and improving self-esteem, participation and wellbeing in children aged 11–13 years.Methods/designIn this two-arm, pragmatic, cluster-randomised controlled trial, 154 children will be recruited from 14 schools. All mainstream schools in the region will be eligible and a convenience sample of 14 schools, stratified by decile ranking (i.e. low, medium, and high) will be recruited. Eight to twelve students aged 11–13 years from each school will be recruited by senior school personnel. Following consent, schools will be randomised to either the intervention or waitlist control arm of the trial. The study will employ a parallel and one-way waitlist-to-intervention crossover design. Each cluster’s involvement will last up to 19 or 31 weeks depending on allocation to the intervention or waitlist respectively. The primary outcome is symptoms of anxiety and secondary outcomes are symptoms of depression, self-esteem, participation in daily occupations and wellbeing. Outcome measurement will be repeated at baseline, post-intervention and again at 8–9 weeks follow-up. Planned statistical analyses will utilise repeated measures analysis of covariance. The primary analysis will be based on an intention-to-treat analysis set and include only parallel data. The crossover data will only be used in secondary analyses.DiscussionThis is the first cluster-randomised controlled trial to investigate an occupational therapy intervention promoting emotional wellbeing in a non-clinical sample of children. Results will contribute to the limited evidence base for occupational therapists in this field and potentially support investment in these services.Trial registrationAustralia/New Zealand Clinical Trials Register: ACTRN12614000453684.

Quality and Reporting of Cluster Randomized Controlled Trials Evaluating Occupational Therapy Interventions

“…Four protocol reports were reviewed, of which three identified as cluster RCTs in the title. Three protocols provided ICCs (range = 0.01-0.05), and one provided a design effect ( Tokolahi, Hocking, Kersten, & Vandal, 2014 ). As these were protocols, there were no data to report when describing baseline comparisons; all four described inclusion and exclusion criteria for the clusters; however, prior to recruitment and randomization, comparison between the study arms was not feasible.…”

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

“…The cluster‐RCT reported here was an ethically sound, well‐designed study with a fully pre‐specified statistical analysis plan (Tokolahi et al., ). Features of the study design that minimised the risk of biases included randomisation at the cluster level, allocation concealment, blinding of participants until after the collection of baseline measures, blinding of outcome assessors, and the use of a control group for comparison during the parallel phase (see Appendix for where each item on the CONSORT statement has been reported).…”

“…Children were excluded if they reported para/suicidal thoughts or behaviours or they were involved with a secondary mental health service. Further details are available in Tokolahi, Hocking, Kersten, and Vandal (2014). This trial was pragmatic as it measured the effectiveness of an intervention in real-world context (i.e.…”

Development and Content of a School-Based Occupational Therapy Intervention for Promoting Emotional Well-Being in Children

“…It uses engagement in developmentally appropriate activities to promote mental health and well-being by enabling students to understand the relationship between what they do and how this influences their identity, self-concept, health and wellbeing; to practice and develop strategies for overcoming difficult emotions; and to apply this knowledge in designing and building healthy routines, behaviors and habits in their day-to-day life. This intervention is currently being evaluated in a cluster randomized controlled trial (Tokolahi et al, 2014).…”

“…Thus, if the cluster randomized controlled trial (in progress (Tokolahi et al, 2014)) demonstrates sufficient effectiveness of this intervention for promoting wellbeing in children, there is scope for introducing it into the health promotion component of schools' curricula. The process described in this paper could be used by other practitioners when developing interventions or seeking to define current interventions more accurately to facilitate more robust evaluation of clinical practice.…”