Quality and reporting of cluster randomised controlled trials evaluating occupational therapy interventions: A systematic review

Background: Growing use of the cluster randomised control trials (RCTs) in healthcare research requires careful attention to study designs, with implications for the development of an evidence-base for practice. Objective: To investigate the characteristics, quality and reporting of cluster-RCTs evaluating occupational therapy interventions to inform future research design. Methods: An extensive search of cluster-RCTs evaluating occupational therapy was conducted in several databases. Results: Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster-RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomised and five reported ICCs (50%): protocols had higher compliance. Risk of bias was most evident in blinding of participants. Statistician involvement was associated with improved trial quality and reporting. Conclusions: Quality of cluster-RCTs of occupational therapy interventions is comparable to those from other areas of health research and needs improvement

Cluster-randomised Controlled Trial of an Occupational Therapy Group Intervention for Children Designed to Promote Emotional Wellbeing: Study Protocol

Background Symptoms 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/design In 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. Discussion This 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 registration Australia/New Zealand Clinical Trials Register: ACTRN12614000453684

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

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 in order 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 -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, co-taught by teachers and including parental involvement

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

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

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

Background Symptoms 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/design In 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. Discussion This 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