Back to resultsEmotion Awareness and Skills Enhancement Program (EASE)
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EASE
Supportive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- ages 12-21 years, inclusive
- 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.
- Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 [WASI-2] FSIQ >=75).
- Fluent in the English language
- Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.
Exclusion Criteria:
- Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
- Previous or current diagnosis of a psychotic disorder.
- 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.
Sites / Locations
- University of Alabama
- Shannondora Porton
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Emotion Awareness/Skills Enhancement
Supportive Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The Clinical Global Impression Scale- Improvement (CGI-I)
The CGI-I will be used as a measure of overall improvement. The CGI-I (Improvement) scale 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.
Secondary Outcome Measures
Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF)
The EDI SF is a measure of emotional reactivity and regulation. The EDI SF is based on theta scores, with a mean of 0 and SD of 1 and possible range from -1.99 to 2.105. Higher scores suggest greater dysregulation, so improvement would be measured by a decrease in scores.
Brief Psychiatric Rating Scale (BPRS)
The Brief Psychiatric Rating Scale (BPRS) is an interview-based measure of psychopathology severity widely used in clinical trials. It consists of 24 items that measure psychiatric symptoms, each of which are on a 1 (not reported) to 7 (very severe) scale, so that lower scores are an indication of improvement. An assignment naïve rater scores the items based upon client report and clinical observation. All scales ask about symptoms over the last 7 days. The single item on "Global Improvement" will be used.
Full Information
NCT ID
NCT03432832
First Posted
January 17, 2018
Last Updated
September 8, 2023
Sponsor
University of Pittsburgh
Collaborators
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03432832
Brief Title
Emotion Awareness and Skills Enhancement Program
Acronym
EASE
Official Title
Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
per protocol analysis versus intent to treat analytic approach due to the pandemic
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emotion Awareness/Skills Enhancement
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EASE
Intervention Description
Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy
Intervention Description
Weekly behavioral sessions with a therapist to work on emotional control
Primary Outcome Measure Information:
Title
The Clinical Global Impression Scale- Improvement (CGI-I)
Description
The CGI-I will be used as a measure of overall improvement. The CGI-I (Improvement) scale 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.
Time Frame
The CGI-I will be completed at 16 weeks (post-treatment)
Secondary Outcome Measure Information:
Title
Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF)
Description
The EDI SF is a measure of emotional reactivity and regulation. The EDI SF is based on theta scores, with a mean of 0 and SD of 1 and possible range from -1.99 to 2.105. Higher scores suggest greater dysregulation, so improvement would be measured by a decrease in scores.
Time Frame
The EDI-SF will be completed at 16 weeks (post-treatment).
Title
Brief Psychiatric Rating Scale (BPRS)
Description
The Brief Psychiatric Rating Scale (BPRS) is an interview-based measure of psychopathology severity widely used in clinical trials. It consists of 24 items that measure psychiatric symptoms, each of which are on a 1 (not reported) to 7 (very severe) scale, so that lower scores are an indication of improvement. An assignment naïve rater scores the items based upon client report and clinical observation. All scales ask about symptoms over the last 7 days. The single item on "Global Improvement" will be used.
Time Frame
The CGI-I will be completed at 16 weeks (post-treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ages 12-21 years, inclusive
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.
Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 [WASI-2] FSIQ >=75).
Fluent in the English language
Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.
Exclusion Criteria:
Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
Previous or current diagnosis of a psychotic disorder.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Mazefsky, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan White
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Facility Name
Shannondora Porton
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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White SW, Ollendick T, Albano AM, Oswald D, Johnson C, Southam-Gerow MA, Kim I, Scahill L. Randomized controlled trial: Multimodal Anxiety and Social Skill Intervention for adolescents with autism spectrum disorder. J Autism Dev Disord. 2013 Feb;43(2):382-94. doi: 10.1007/s10803-012-1577-x.
Results Reference
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PubMed Identifier
27262124
Citation
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.
Results Reference
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PubMed Identifier
28685409
Citation
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.
Results Reference
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Emotion Awareness and Skills Enhancement Program
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