Promoting psychological well-being in preschool children: study protocol for a randomized controlled trial of a mindfulness- and yoga-based socio-emotional learning intervention

The objective of this trial is to rigorously evaluate the effect of a 24-week combined mindfulness- and yoga- based SEL intervention in preschool children from a French socio-economically disadvantaged area.MethodsThe P-WB promotion intervention is compared to a wait-list control condition in a cluster randomized controlled trial (RCT). Sixty-four pre-Kindergarten classrooms are randomized to the intervention or control group. Primary outcomes measure self-management capacity and core P-WB components: connection, insight, engagement, and positive relationship. Secondary outcomes include measures of mental health, executive functioning, and school performance. Primary and secondary outcomes are assessed through teacher questionnaires, standardized observations of children in school context, and experimental tasks and by collecting results of the national evaluation at first grade. All children-level outcomes are evaluated at pre-intervention, at the end of the intervention, and 1 year later (follow-up analysis), to the exception of school performance which is evaluated at follow-up only. Intention-to-treat analyses, accounting for clustering within classes, will adopt a random effects linear regression model to examine outcomes for the intervention versus control children.DiscussionThis is the first trial to rigorously evaluate a combined mindfulness- and yoga-based P-WB promotion intervention, and the first RCT evaluating a SEL curriculum in French schools. Results may have k...
Source: Trials - Category: Research Source Type: clinical trials