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Trial record 4 of 31 for:    Developmental Disabilities | ( Map: Alabama, United States )

Emotion Awareness and Skills Enhancement Program (EASE-yes)

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ClinicalTrials.gov Identifier: NCT03432832
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Carla Mazefsky, University of Pittsburgh

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).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: EASE Behavioral: Supportive Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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. 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.
Behavioral: EASE
Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.

Active Comparator: Supportive Therapy
Supportive Therapy will involve attending 16 weekly therapy sessions held in Webster Hall in Pittsburgh or at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa. 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.
Behavioral: Supportive Therapy
Weekly behavioral sessions with a therapist to work on emotional control




Primary Outcome Measures :
  1. The Clinical Global Impression Scale- Improvement (CGI-I) [ Time Frame: The CGI-I will be completed at 16 weeks (post-treatment) ]
    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 :
  1. Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF) [ Time Frame: The EDI-SF will be completed at 16 weeks (post-treatment). ]
    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.

  2. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: The CGI-I will be completed at 16 weeks (post-treatment) ]
    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.



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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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] Verbal Intelligence Quotient>80).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432832


Contacts
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Contact: Carla A Mazefsky, Ph.D 412-246-5459 mazefskyca@upmc.edu
Contact: Susan White, Ph.D. 205-348-3535 swwhite@ua.edu

Locations
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United States, Alabama
University of Alabama Recruiting
Tuscaloosa, Alabama, United States, 35487
Contact: Susan White, PhD    205-348-3535    swwhite@ua.edu   
Contact: Nicole Powell, PhD    205-348-3535    npowell@ua.edu   
Principal Investigator: Susan White, PhD         
United States, Pennsylvania
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Carla Mazefsky, PhD    412-246-5459    mazefskyca@upmc.edu   
Contact: Michelle Perrin, MBA    866-647-3436    autismrecruiter@upmc.edu   
Principal Investigator: Carla Mazefsky, PhD         
Sponsors and Collaborators
University of Pittsburgh
University of Alabama at Birmingham
Investigators
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Principal Investigator: Carla Mazefsky, PhD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Carla Mazefsky, University of Pittsburgh:

Publications:
Abidin, R. R. (2012). Parenting Stress Index, Fourth Edition Short Form (PSI-4). Lutz, FL: PAR.
Achenbach, T. M., & Rescorla, L. (2001). Manual for the ASEBA school-age forms and profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.

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Responsible Party: Carla Mazefsky, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03432832     History of Changes
Other Study ID Numbers: PRO17070496
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders