Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

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

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: The Emotion Awareness and Skills Enhancement Program; Behavioral: The Unified Protocol

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 12 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): 470
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kara Duman, MSW; Phone Number: 1-866-647-3436; Email: emotiontherapy@upmc.edu
• Study Contact Backup: Name: Madison Bradley; Phone Number: 205-348-2472; Email: emotiontherapy@ua.edu

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35401
      • Recruiting
      • University of Alabama
      • Contact: Madison Bradley; Phone Number: 205-348-2472; Email: emotiontherapy@ua.edu
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Kara L Duman, MSW; Phone Number: 1-866-647-3436; Email: emotiontherapy@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

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.	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.; 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.	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.; Other Names: UP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Depression	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	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	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
Child & Adolescent Mindfulness Measure	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)
Satisfaction with Life Scale	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)
Relationships, Employment, Autonomy, and Life Satisfaction	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	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	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
Clinical Global Impressions	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.	Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
Emotion Regulation Questionnaire for Children and Adolescents	ERQ-CA 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
WHO Quality of Life-BREF-ID	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), 3 months following post-treatment
Self-Compassion Scale-Youth Version	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), 3 months following post-treatment
Credibility and Expectancy Questionnaire	It will assess treatment expectancy and rationale for the assessed treatments.	Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
AASPIRE Patient Health Questionnaire-9	This is a 9-item self-report questionnaire for screening, diagnosing, monitoring and measuring the severity of depression, that includes an item that is widely utilized as an index of suicidal ideation severity. Each item is rated on a scale from Rarely or not at all to Almost every day. Higher scores would relate to higher depression.	Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Inventory of Statements about Self-Injury	ISAS is a continuous self-report measure of self-injurious behaviors. It is the most commonly used measure of self-injury. Higher numbers in Section 1 would indicate more self-injurious behaviors.	Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Working Alliance Inventory	WAI is a clinician-report measure assessing the therapeutic alliance between the client/participant and the clinician. The measure is 12 items, rated on a 5-point scale.	Midpoint (after completing 8 sessions, average 8 weeks), After completing 15 sessions (average 15-19 weeks)
Vanderbilt Therapeutic Alliance Scales Revised, Short Form	VTAS-R-SF is an observational measure of alliance and consists of five items to capture the strength of the perceived support and trust, participation, and agreement on tasks and goals between client and therapist. Each item is rated 0-5, and higher scores mean more alliance. The measure is used for coding videos or audio files of the therapy sessions. It will be completed twice with each participant but the timepoint is randomized (one randomized session from the first half of therapy and one randomized session from the second half of therapy).	2 randomized timepoints over up to 20 Weeks
Child Involvement Rating Scale	Child Involvement Rating Scale is a 10-item, 6-point observational scale to rate involvement and engagement during therapy. The first 6 items rate positive involvement where 0 is not at all and 5 is a great deal. The last 4 items rate negative involvement where 0 is not at all and 5 is a great deal. The measure is used for coding videos or audio files of the therapy sessions. The measure will be completed twice with each participant but the timepoint is randomized (one randomized session from the first half of therapy and one randomized session from the second half of therapy).	2 randomized timepoints over up to 20 Weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Patient-Centered Outcomes Research Institute; University of Alabama, Tuscaloosa
• Investigators: Principal Investigator: Carla Mazefsky, PhD, University of Pittsburgh; Principal Investigator: Susan White, PhD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Ellard 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.
• 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.
• Barlow 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.
• Ehrenreich-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.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 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 (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• 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