Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
113 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-01-30
Study Completion Date
2024-07-30
Brief Summary
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This project will address impaired emotion regulation in adolescents with ASD (autism spectrum disorder). There are no evidence-based interventions to improve emotion regulation (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and function across all life settings, and reduce their quality of life and that of their families. The primary objective of this study is to formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled trial (RCT).
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Detailed Description
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The current study is to test a new intervention called Emotional Awareness and Skills Enhancement (EASE). This program was designed to address ASD-specific obstacles to effective emotion regulation, such as reduced awareness concerning others' intentions, a limited repertoire of behavioral responses, and inadequate language for understanding emotional experiences. This new program is based on an acceptance-based approach in which awareness of emotion is developed, emotions (whether negative or positive) are accepted, and behavior is regulated in the face of intense emotion. The goal is not to learn to avoid negative emotions, but rather to develop a collection of abilities which allow the individual to manage stress and act in ways that are more adaptive. The investigators expect to find that participants' emotion dysregulation will decrease and their adaptive function will increase following completion of the EASE program.
Conditions
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Autism Spectrum Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
per protocol analysis versus intent to treat analytic approach due to the pandemic
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Emotion Awareness/Skills Enhancement
EASE Therapy includes 16 weekly sessions focused on mindfulness exercise, review of prior content, practicing prior skills, outline of current session, discussion of the new skill, handouts, practice and plan for out of session practice held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The investigators will apply a multimodal teaching approach, where individual therapy is buttressed by parent involvement and practice sessions in the youth's community. A secure website developed for this project (emotion-Coach or "e-Coach") will augment the intervention by providing online supports to increase treatment intensity or dosage. There will be specific information on how to reinforce the skills at home and in the community.
Group Type
EXPERIMENTAL
EASE
Intervention Type
BEHAVIORAL
Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.
Supportive Therapy
Supportive Therapy will involve attending 16 weekly therapy sessions held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The intervention will not involve mindfulness or other emotion regulation strategies used in EASE. The therapy will be tailored to the individual's needs and will include aspects common in supportive therapy such as reflective listening, antecedent management, and problem-solving. This program does not have an online component.
Group Type
ACTIVE_COMPARATOR
Supportive Therapy
Intervention Type
BEHAVIORAL
Weekly behavioral sessions with a therapist to work on emotional control
Interventions
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EASE
Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.
Intervention Type
BEHAVIORAL
Supportive Therapy
Weekly behavioral sessions with a therapist to work on emotional control
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. ages 12-21 years, inclusive
2. A diagnosis of ASD (autism spectrum disorder), as defined by exceeding the ASD cutoff on the ADOS-2 (Autism Diagnostic Observation Scale) or ADI-R (Autism Diagnostic Interview-Revised) In. If the participant has completed the ADOS in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ADOS.
3. Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 \[WASI-2\] FSIQ \>=75).
4. Fluent in the English language
5. Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.
2. A diagnosis of ASD (autism spectrum disorder), as defined by exceeding the ASD cutoff on the ADOS-2 (Autism Diagnostic Observation Scale) or ADI-R (Autism Diagnostic Interview-Revised) In. If the participant has completed the ADOS in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ADOS.
3. Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 \[WASI-2\] FSIQ \>=75).
4. Fluent in the English language
5. Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.
Exclusion Criteria
1. Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
2. Previous or current diagnosis of a psychotic disorder.
3. Receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. This will be assessed using current treatment items on the demographic forms.
2. Previous or current diagnosis of a psychotic disorder.
3. Receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. This will be assessed using current treatment items on the demographic forms.
Minimum Eligible Age
12 Years
Maximum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Alabama at Birmingham
OTHER
Sponsor Role
collaborator
University of Pittsburgh
OTHER
Sponsor Role
lead
Responsible Party
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Carla Mazefsky
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Carla Mazefsky, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Susan White
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama
Tuscaloosa, Alabama, United States
Site Status
Shannondora Porton
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
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White SW, Elias R, Salinas CE, Capriola N, Conner CM, Asselin SB, Miyazaki Y, Mazefsky CA, Howlin P, Getzel EE. Students with autism spectrum disorder in college: Results from a preliminary mixed methods needs analysis. Res Dev Disabil. 2016 Sep;56:29-40. doi: 10.1016/j.ridd.2016.05.010. Epub 2016 Jun 1.
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White SW, Elias R, Capriola-Hall NN, Smith IC, Conner CM, Asselin SB, Howlin P, Getzel EE, Mazefsky CA. Development of a College Transition and Support Program for Students with Autism Spectrum Disorder. J Autism Dev Disord. 2017 Oct;47(10):3072-3078. doi: 10.1007/s10803-017-3236-8.
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BACKGROUND
White SW, Conner CM, Beck K, Mazefsky CA. Efficacy of the Emotion Awareness and Skills Enhancement (EASE) Program in Autism: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Jul 31:S0890-8567(25)01410-8. doi: 10.1016/j.jaac.2025.07.1058. Online ahead of print.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY20110317
Identifier Type: -
Identifier Source: org_study_id
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