Autism spectrum disorder affects approximately one in 50 individuals, and up to one in two autistic people has a co-occurring intellectual disability (ID). Although autism persists into adulthood, there has been very little research devoted to supporting autistic adults, or their clinical care. In particular, the gap in understanding of how to best support mental health for autistic individuals has been uniformly identified as a priority by autistic adults, their caregivers, clinicians, and other stakeholders.
Co-occurring mental health problems affect the majority of autistic adolescents and adults and have a negative impact on quality of life. Clinically elevated emotion dysregulation, difficulty managing strong negative emotions, and reactions to stressful situations are common with autism. Emotion dysregulation is believed to be a key cause of higher rates of mental health conditions in autism. Interventions that improve emotion dysregulation may be clinically effective in addressing the mental health concerns for which autistic people seek help.
However, many clinicians do not feel that they have adequate guidance regarding the most appropriate intervention approach for autistic adolescents and adults with mental health problems. Clinicians may be hesitant to work with autistic patients because it is unclear if they should use standard interventions (i.e., created for non-autistic patients) or an autism-specific approach.
Therefore, the project team is conducting a comparative effectiveness randomized controlled trial comparing a mindfulness-based intervention developed for autistic patients, Emotion Awareness and Skills Enhancement (EASE), to the Unified Protocol (UP), an established cognitive-behavioral intervention that was not developed for autistic people. This research is focused on patient-centered research questions and outcomes as identified in calls from advocacy organizations, autistic individuals, caregivers, clinicians, and other allies of the autistic community to improve mental health care and outcomes. The project team is measuring treatment outcomes that have been identified as important by the autistic community, including emotion dysregulation, mental health symptoms, autism flourishing and burnout, and quality of life. The focus is on an underserved and vulnerable group: autistic adolescents and young adults with mental health difficulties, with and without intellectual ID. This is intentional, as few other clinical trials have enrolled autistic adults or those with ID.
Using a bidirectional community-engaged approach will ensure the project remains patient-centered and inclusive of people who have been largely underserved in clinical research (e.g., those who lack access due to factors such as rurality and poverty). The project team will randomize ten community mental health clinics across two states to use either EASE or UP with 470 enrolled autistic patients. They will work together with community stakeholders through the entire research process to determine relative effectiveness and acceptability of the interventions, as well as potential harms and secondary impacts. The project team anticipates that patients, their families, and mental healthcare providers will use results from this study to increase access to evidence-based mental health care for autistic adolescents and adults and that findings will directly inform clinical decision making.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.