Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials

BACKGROUND: The Centers for Disease Control (2018) estimates that 1 in 59 children has autism spectrum disorder, and the annual cost of ASD in the U.S. is estimated to be $236 billion. Evidence-based interventions have been developed and demonstrate effectiveness in improving child outcomes. However, research on generalizable methods to scale up these practices in the multiple service systems caring for these children has been limited and is critical to meet this growing public health need. This project includes two, coordinated studies testing the effectiveness of the Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy (TEAMS) model. TEAMS focuses on improving implementation leadership, organizational climate, and provider attitudes and motivation in order to improve two key implementation outcomes—provider training completion and intervention fidelity and subsequent child outcomes. The TEAMS Leadership Institute applies implementation leadership strategies and TEAMS Individualized Provider Strategies for training applies motivational interviewing strategies to facilitate provider and organizational behavior change. METHODS: A cluster randomized implementation/effectiveness Hybrid, type 3, trial with a dismantling design will be used to understand the effectiveness of TEAMS and the mechanisms of change across settings and participants. Study #1 will test the TEAMS model with AIM HI (An Individualized Mental Health Intervention for ASD) in publicly funded mental health services. Study #2 will test TEAMS with CPRT (Classroom Pivotal Response Teaching) in education settings. Thirty-seven mental health programs and 37 school districts will be randomized, stratified by county and study, to one of four groups (Standard Provider Training Only, Standard Provider Training + Leader Training, Enhanced Provider Training, Enhanced Provider Training + Leader Training) to test the effectiveness of combining standard, EBI-specific training with the two TEAMS modules individually and together on multiple implementation outcomes. Implementation outcomes including provider training completion, fidelity (coded by observers blind to group assignment) and child behavior change will be examined for 295 mental health providers, 295 teachers, and 590 children. DISCUSSION: This implementation intervention has the potential to increase quality of care for ASD in publicly funded settings by improving effectiveness of intervention implementation. The process and modules will be generalizable to multiple service systems, providers, and interventions, providing broad impact in community services. TRIAL REGISTRATION: This study is registered with Clinicaltrials.gov (NCT03380078). Registered 20 December 2017, retrospectively registered.