Study protocol for a comparative effectiveness randomized controlled trial comparing the emotion awareness and skills enhancement program to the unified protocol in autistic youth and young adults with emotion dysregulation

Many autistic people seek therapy for mental health concerns or to improve emotional wellbeing. Unfortunately, there is limited guidance for providers on the most effective approach to improve mental health for autistic people. Therapies that target emotion dysregulation may be clinically effective and parsimonious. However, it remains unclear if emotion dysregulation interventions that were not developed for autism are effective or if interventions developed for autistic clients may confer additional benefits in terms of effectiveness and ease of implementation by community clinicians. The Emotion Awareness and Skills Enhancement (EASE) Program was developed to target emotion dysregulation specifically in autism, and has been shown to be efficacious for autistic youth and young adults in a standard clinical trial conducted in a research setting. In this Hybrid Type 1 comparative effectiveness randomized controlled trial, we examine clinical impact and implementation outcomes across two treatments. The target intervention is a mindfulness-based curriculum developed for autistic clients (EASE) compared to the child, adolescent, and adult Unified Protocols (UP), established interventions rooted in cognitive-behavioral therapy that were not developed for autistic clients. This research is based on a community-driven, advisory model, including two community partner groups that provide input on project implementation. Providers are community clinicians at mental health agencies in Pennsylvania and Alabama, with randomization by agency. Clients include autistic individuals aged 10 to 30 years, with a target sample size of 400. Data are collected at pre-, mid-, post-, and 3 months following therapy. The primary aim is to test comparative effectiveness. The secondary aim is to evaluate the feasibility, benefits, harms, and implementation outcomes. A third exploratory aim focuses on moderators of outcome. EASE is hypothesized to outperform UP. The primary outcomes are client emotion dysregulation and provider-rated acceptability and feasibility of implementation. Secondary outcomes include responder status determined by a condition-naive interviewer, questionnaires of mental health, quality of life, and client satisfaction, and coder-rated therapeutic alliance. Qualitative data on feasibility and implementation outcomes is collected from clients, providers, and agency leaders. Findings will inform clinical decision-making and hopefully help increase access to evidence-based mental healthcare for autistic individuals. This trial is registered with ClinicalTrials.gov ID NCT06158581. It was first registered on 11/27/23.