Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

January 4, 2024 updated by: Carla Mazefsky, University of Pittsburgh

The Emotion Awareness and Skills Enhancement (EASE) Program Versus the Unified Protocol (UP)

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.

Study Overview

Detailed Description

This study will compare the effectiveness of two transdiagnostic interventions for autistic adolescents and young adults - an intervention in widespread use among non-autistic populations (The Unified Protocol; UP) versus an autism-specific intervention (The Emotion Awareness and Skills Enhancement Program; EASE). The UP and EASE are ideal comparators because they are structurally equivalent and transdiagnostic - both shown to improve mental health outcomes that stakeholders identify as important, such as depression, irritability, and anxiety. The investigators will partner with 10 different community clinics in Pennsylvania and Alabama to recruit participants and facilitate the interventions. Each clinic will be randomized to use either UP or EASE. The investigators will look at effectiveness of the treatments, as well as the feasibility, benefits and harms.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Alabama
      • Tuscaloosa, Alabama, United States, 35401
        • University of Alabama
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • professional diagnosis of ASD
  • a score in the clinical range on the EDI-Reactivity (7 item) or Dysphoria scale (6 item) based on caregiver report
  • communicative ability (verbal or nonverbal)
  • Clinician judgment that person could meaningfully participate and potentially benefit
  • A caregiver or other adult with consistent contact who can complete assessments
  • Client must live in Alabama or Pennsylvania
  • Home access to internet and device for online assessments and meetings

Exclusion Criteria:

  • acute psychosis
  • imminent suicide/homicide threat
  • intoxication
  • mania

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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.

Other Names:
  • EASE
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.

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.

Other Names:
  • UP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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: Post treatment (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.
Post treatment (after all 16 sessions, average 16-20 weeks)
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.
Baseline and Post trial (4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impressions
Time Frame: Post treatment (after all 16 sessions, average 16-20 weeks)
The CGI will be used as a measure of overall improvement. The CGI was designed to measure overall symptomatic change at a specific time as compared to baseline that is completed by a rater who is blind to treatment assignment. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). It is only a single item, and lower scores indicate more improvement.
Post treatment (after all 16 sessions, average 16-20 weeks)
Columbia-Suicide Severity Rating Scale
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
C-SSRS is a widely used interview of the frequency and severity of suicidal ideation and behaviors.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
PROMIS Depression
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
It is a brief, change sensitive 8 item measure. It is a 1-5 scale, where 1 is Never and 5 is Always.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
PROMIS Anxiety
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
It is a brief, change sensitive 8 item measure. It is a 1-5 scale, where 1 is Never and 5 is Always.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Buss-Perry Aggression Questionnaire
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
27-item self-report measure of general aggression, physical aggression, verbal aggression, anger, and hostility. It is a 1-7 scale, where 1 is Extremely uncharacteristic of me and 7 is Extremely characteristic of me.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Emotion Regulation Questionnaire
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
ERQ has10 items that comprise of two scales: cognitive reappraisal use and expressive suppression, which are two regulatory strategies considered adaptive and protective in terms of mental health. It is a 1-7 scale, where 1 is Strongly disagree and 7 is Strongly agree.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Child & Adolescent Mindfulness Measure
Time Frame: Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks)
CAMM is a 10-item self-report measure of mindfulness. It is a 0-4 scale, where 0 is Never true and 4 is Always true. When scoring, you reverse all scores (i.e. 0 to 4) and then sum. Higher scores correspond to higher levels of mindfulness.
Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks)
WHO Quality of Life-BREF-ID
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
WHOQoL-BREF-ID is a simplified version of the World Health Organization Quality of Life. It has a 3 or 5 point visual response scale, where 1 is Not at all and 5 is Totally.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
Satisfaction with Life Scale
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
Satisfaction was Life Scale is a 5-item measure of global life satisfaction. It is a 1-7 scale, where 1 is Strongly disagree and 7 is Strongly agree.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
Self-Compassion Scale-Youth Version
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
Self-Compassion Scale - Youth Version consists of 17 self-report items ranked on a 5-point Likert scale, yielding six subscales (self-kindness, self-judgment, common humanity, isolation, mindfulness, over-identification) and an overall score. 1 is Almost Never and 5 Almost Always.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
Relationships, Employment, Autonomy, and Life Satisfaction
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
REALS Measures are a compilation of scales tapping many areas of adult life. Each scale is scored independently and should be utilized as different sources of information. It does not produce a global outcome score. With the frequency scales, it is a 0-4 scale where 0 is Never and 4 is Always.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
AASPIRE Flourishing Scale
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
It is 9 item scale that assesses aspects of life satisfaction for autistic individuals. It is a scale from strongly disagree to strongly agree.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
AASPIRE Burnout Scale Short Form
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
It is a 14-item self-report measure of autistic burnout. It is a scale from strongly disagree to strongly agree.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Credibility and Expectancy Questionnaire
Time Frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
It will assess treatment expectancy and rationale for the assessed treatments.
Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carla Mazefsky, PhD, University of Pittsburgh
  • Principal Investigator: Susan White, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY23090024
  • IDD-2022C1-26418 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will be uploaded to the repository by December 2027.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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