Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults
The Emotion Awareness and Skills Enhancement (EASE) Program Versus the Unified Protocol (UP)
2 other identifiers
interventional
470
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 6, 2023
CompletedStudy Start
First participant enrolled
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 13, 2026
April 1, 2026
3.3 years
November 27, 2023
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Emotion Dysregulation Inventory
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.
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
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.
Baseline and Post treatment of first client (after all 16 sessions, average 16-20 weeks)
Provider Self-Efficacy Scale
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.
Baseline and Post trial (4 years)
Secondary Outcomes (18)
Clinical Global Impressions
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
PROMIS Depression
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
PROMIS Anxiety
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Buss-Perry Aggression Questionnaire
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Emotion Regulation Questionnaire for Children and Adolescents
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
- +13 more secondary outcomes
Study Arms (2)
The Emotion Awareness and Skills Enhancement
EXPERIMENTALEASE 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.
The Unified Protocol
ACTIVE COMPARATORUP 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- Higher level of care is needed (Imminent Suicide / Homicide Threat, acute psychosis, mania)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- University of Alabama, Tuscaloosacollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (2)
University of Alabama
Tuscaloosa, Alabama, 35401, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (4)
Conner CM, White SW, Beck KB, Golt J, Smith IC, Mazefsky CA. Improving emotion regulation ability in autism: The Emotional Awareness and Skills Enhancement (EASE) program. Autism. 2019 Jul;23(5):1273-1287. doi: 10.1177/1362361318810709. Epub 2018 Nov 7.
PMID: 30400749BACKGROUNDEllard KK, Fairholme CP, Boisseau CL, Farchione TJ, Barlow DH. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: Protocol Development and Initial Outcome Data. Cogn Behav Pract. 2010 Feb;17(1):88-101. doi: 10.1016/j.cbpra.2009.06.002. Epub 2010 Jan 29.
PMID: 33762811BACKGROUNDBarlow DH, Farchione T, Sauer-Zavala, Shannon Murray Latin H, et al. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. Second Edi. Oxford University Press; 2017.
BACKGROUNDEhrenreich-May J, Kennedy SM, Sherman JA, et al. Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents: Therapist Guide. Oxford University Press; 2017.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Mazefsky, PhD
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Susan White, PhD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- A rater blind to condition assignment will assign CGI ratings.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry, Psychology, and Clinical and Translational Science
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 6, 2023
Study Start
April 8, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The data will be uploaded to the repository by December 2027.
- Access Criteria
- Investigators must submit a data request to the PCORI-designated repository. If the request is approved, the data requestor's institution must enter into a Data Use Agreement with the repository. If the investigators receive requests for data directly from a third party, the investigators will need to notify PCORI if the data is not yet in the repository.
PCORI, the funder, is committed to open science and the investigators are required to deposit their Full Data package in a PCORI-designated data repository. The investigators will enter into a Data Contributor Agreement with a PCORI-designated repository after the investigators complete data collection. The repository will make the Full Data Package available for third-party requests when PCORI makes the Final Research Report available on the PCORI website, or at the time of publication of the research project's primary results in a peer-reviewed journal, whichever comes first.