Implementation successes and lessons learnt from a randomised controlled trial of a complex school-based intervention

Abstract

Background The UK has seen a recent shift towards children’s mental health being supported and treated in school settings. Several current school-based interventions focus on autism and social skills, with education professional involvement in their delivery increasing. The study of these interventions poses specific implementation challenges. This paper discusses implementation successes and learnings from the I-SOCIALISE research study which delivered and evaluated efficacy of LEGO® based therapy (now Play Brick Therapy) for autistic children and young people delivered in schools. Detailed Methods and results of the trial are reported elsewhere. Methods The I-SOCIALISE study was a pragmatic large-scale NIHR-funded cluster randomised controlled trial. Children and young people, their parents/guardians, and schoolteachers or teaching assistants were recruited from mainstream schools in the UK. They completed outcome measures and were randomised to receive either 12-week of LEGO® based therapy and usual support or usual support only. Various methods to achieve successful recruitment and retention were used and learnings were documented. Results The study recruited to time and target with successful delivery of this complex intervention in schools. Several lessons were learnt about recruitment methods, data collection, participant burden and retention, blinding, and the importance of relationships with key school contacts. Main recommendations based on these learnings are provided. Conclusions This study demonstrated that it is possible to undertake large scale, robust evaluation of pragmatically delivered complex school-based interventions. Recommendations are made to address the logistical challenges of undertaking research in this setting which are intended to facilitate future research.