NCT06158581 · University of Pittsburgh
Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults
What this study is about
Too few clinicians are able and willing to help autistic patients. A recent review identified challenges to mental health service delivery in autism, including a lack of interventions designed for community implementation and limited workforce capacity.
View original scientific description
Too few clinicians are able and willing to help autistic patients. A recent review identified challenges to mental health service delivery in autism, including a lack of interventions designed for community implementation and limited workforce capacity. It has been argued that improving impairment in emotion regulation has the potential to improve a range of mental health difficulties in autistic people. In this clinical trial, the investigators are comparing two evidence-based interventions for emotion regulation, to determine if one created specifically for autistic people is clinically superior. The interventions will be implemented in the community, through partnering agencies.
Interventions
BEHAVIORAL
The Emotion Awareness and Skills Enhancement Program
EASE is a cutting-edge program created by researchers at the University of Alabama and the University of Pittsburgh in collaboration with autistic individuals, caregivers of autistic youth, and therapists. The overarching goal of the program is to support autistic clients who want to work on emotion regulation. EASE is unique because it targets emotional distress in autistic youth and adults, instead of targeting the core symptoms of autism (i.e., it is not a social skills intervention). The program is a 16-session, mindfulness-based intervention. Each session is 1:1 for 45 minutes to one hour. While the program is designed for individual intervention, caregivers are also invited to play an active role on the care team.
BEHAVIORAL
The Unified Protocol
UP is a thoroughly-studied, manualized intervention created by researchers at the University of Miami in conjunction with researchers at Boston University. The program was designed to be customizable to meet the needs of people with a variety of diagnoses, allowing more individuals to access emotion regulation resources. The protocol also has different modules to accommodate different developmental levels (UP-Children, UP-Adolescent, UP-Adult). The overall goal of UP is to help clients identify emotions and build new strategies to cope with stressful life situations and distressing emotions. The protocol is flexible, with each session is about 45 to 60 minutes and the number of sessions varying between 12 - 21 sessions. For the current study, the treatment will take place over 16 sessions. The intervention is cognitive behavioral therapy (CBT) based but also includes hints of mindfulness-based intervention strategies.
Primary outcome measures
Emotion Dysregulation Inventory
Time frame: Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
The EDI does not have a single overall score. It is comprised of two scales: Reactivity and Dysphoria. Items are on a 0 to 4 scale, where 0 is Never happens and 4 is Almost always happens or causes a serious problem. There are clinical cutoffs for both scales.
Weiner's Acceptability, Appropriateness, & Feasibility of Intervention Scales
Time frame: Baseline and Post treatment of first client (after all 16 sessions, average 16-20 weeks)
Weiner's is a widely used 12-item battery of three scales assessing intervention acceptability, appropriateness, and feasibility with strong psychometric properties. There is a 1 to 5 scale, where 1 is Completely disagree and 5 is Completely agree. Higher scores indicate greater acceptability, appropriateness, and feasibility.
Provider Self-Efficacy Scale
Time frame: Baseline and Post trial (4 years)
It assesses both knowledge (of protocol) and confidence (in one's ability to implement as intended). It is a 0-10 scale, where 0 is not at all confident and 10 is extremely confident. Higher scores indicate higher confidence.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Tuscaloosa, Alabama
- Pittsburgh, Pennsylvania
Collaborators
University of Alabama, Tuscaloosa, Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations