Comparing two therapies for emotion regulation in autistic youth and young adults
The Emotion Awareness and Skills Enhancement (EASE) Program Versus the Unified Protocol (UP)
This study is testing two different therapies to see which one helps autistic teens and young adults better manage their emotions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 470 (estimated) |
| Ages | 10 Years to 30 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Tuscaloosa, Alabama and 1 other locations) |
| Trial ID | NCT06158581 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two interventions designed to improve emotion regulation in autistic adolescents and young adults. One intervention is the Unified Protocol, commonly used for non-autistic populations, while the other is the Emotion Awareness and Skills Enhancement Program, specifically designed for autistic individuals. The study will be conducted in partnership with ten community clinics in Pennsylvania and Alabama, where each clinic will be randomized to implement either intervention. The researchers will assess the effectiveness, feasibility, and potential benefits or harms of both treatments.
Who should consider this trial
Good fit: Ideal candidates are autistic adolescents and young adults who can consent to participate and have a support person to assist with the study.
Not a fit: Patients requiring a higher level of care due to imminent suicide or homicide threats, acute psychosis, or mania may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide tailored emotion regulation therapies that significantly improve mental health outcomes for autistic individuals.
How similar studies have performed: Other studies have shown success with similar emotion regulation interventions, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * professional diagnosis of ASD * a score in the clinical range on the EDI-Reactivity or EDI-Dysphoria scale based on caregiver report or self-report * The study is open to people with a range of communication abilities. Participants must be able to consent to the study themselves and answer questions about themselves. * Participants need to have a support person that could answer questions about them too. This could be a parent, caregiver, family member, partner or friend. Independent adults can opt out of this portion. * Participants must live in Alabama or Pennsylvania. Exclusion Criteria: \- Higher level of care is needed (Imminent Suicide / Homicide Threat, acute psychosis, mania)
Where this trial is running
Tuscaloosa, Alabama and 1 other locations
- University of Alabama — Tuscaloosa, Alabama, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Carla Mazefsky, PhD — University of Pittsburgh
- Study coordinator: Kara Duman, MSW
- Email: emotiontherapy@upmc.edu
- Phone: 1-866-647-3436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.