Recruiting

Emotion Therapies

Sponsor:

University of Pittsburgh

Code:

NCT06158581

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 10 - 30

Healthy Volunteers: Not accepted

Interventions

The Emotion Awareness and Skills Enhancement Program

The Unified Protocol

Study Details

Brief summary:

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT06158581

Start date

Apr 8, 2024

Status verified date

Apr, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 30

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

470 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: The Emotion Awareness and Skills Enhancement

EASE is a 16-session mindfulness-based intervention (MBI). It emphasizes a small set of core concepts (i.e., mindfulness practices, distress tolerance, encouraging helpful thoughts, self-compassion) that are repeated with consistent language throughout. Emphasis is placed on increasing awareness of gradients of emotional arousal.

active comparator: The Unified Protocol

UP is a 12-21 session cognitive behavioral therapy (CBT) based treatment. In this study, there will be 16 sessions. UP is focused on identifying emotions and building new coping strategies. It is customizable to meet the needs of the individual.

Interventions

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.

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 measure

  • 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 ]
  • 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) ]
  • Provider Self-Efficacy Scale [ Time Frame: Baseline and Post trial (4 years) ]

Central Contacts and Locations

Central contacts

Kara Duman, MSW

1-866-647-3436emotiontherapy@upmc.edu

Madison Bradley

205-348-2472emotiontherapy@ua.edu

Locations

University of Alabama

Recruiting

Tuscaloosa, Alabama, United States, 35401

Contacts

Madison Bradley

205-348-2472emotiontherapy@ua.edu

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Kara L Duman, MSW

1-866-647-3436emotiontherapy@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-13.