Protocol for a feasibility randomized controlled pilot trial evaluating a teacher program to support preschool children with autism and language delay

Abstract

Abstract Background Early intervention in naturalistic settings is essential for supporting young children with difficulties within the autism spectrum. In recent decades, there has been an increasing inclusion of children with developmental problems in mainstream schools. However, both the research on the implementation and effectiveness of evidence-based teacher-mediated interventions, as well as the actual implementation of these interventions in practice, remain limited. The Incredible Years - Helping Preschool Children with Autism (IY-HPCA ® ) program is designed for teachers of children aged 2–5 years, offering strategies to promote language development, social interaction, emotional literacy and self-regulation skills. To date, no scientific studies have evaluated the feasibility or effectiveness of delivering the IY-HPCA ® program. This pilot study aims to assess the feasibility of implementing this program within the public education and health systems, and to preliminarily explore its effectiveness on teaching strategies, teacher self-efficacy, and burnout. Methods We will conduct a pragmatic pilot, randomized, controlled, parallel-group exploratory trial recruiting approximately 40 teachers of preschool children aged 2.11–5.11 years working at mainstream schools in the Barcelona region. Participants will be randomly allocated to the intervention or control group in a 1:1 ratio. The intervention will consist of six weekly sessions and will be delivered by clinical psychologists and child psychiatrists at Sant Joan de Déu Hospital (Barcelona). Primary feasibility outcomes include recruitment rates, attendance, intervention fidelity, and participant satisfaction. Secondary outcomes assessing preliminary effectiveness include teachers’ use of strategies, self-efficacy, and burnout, measured using validated questionnaires. Additionally, semi-structured interviews with participating teachers and group leaders will explore their experiences with the program. Discussion This study will provide pioneering preliminary data on the implementation of the IY-HPCA ® program for teachers of preschool children with autism. The results will inform the feasibility and potential effectiveness of this intervention, guiding future larger-scale trials of implementing the program within the public educational and health systems. Trial registration: ClinicalTrials.gov. NCT06790199, date of registration: first submitted 2025-01-17; first posted 2025-01-23, URL of trial registry record: https://clinicaltrials.gov/study/NCT06790199