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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

Tracking Information
First Submitted Date  ICMJE January 17, 2018
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE January 30, 2018
Estimated Primary Completion Date January 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03432832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotion Awareness and Skills Enhancement Program
Official Title  ICMJE Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Behavioral: EASE
    Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.
  • Behavioral: Supportive Therapy
    Weekly behavioral sessions with a therapist to work on emotional control
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: EASE
  • 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.
    Intervention: Behavioral: Supportive Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date January 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carla A Mazefsky, Ph.D 412-246-5459 mazefskyca@upmc.edu
Contact: Susan White, Ph.D. 205-348-3535 swwhite@ua.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03432832
Other Study ID Numbers  ICMJE PRO17070496
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carla Mazefsky, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE University of Alabama at Birmingham
Investigators  ICMJE
Principal Investigator: Carla Mazefsky, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP