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 : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: EASE Behavioral: Supportive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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
- 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.
- 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.
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
|Contact: Carla A Mazefsky, Ph.Dfirstname.lastname@example.org|
|Contact: Susan White, Ph.D.||email@example.com|
|United States, Alabama|
|University of Alabama||Recruiting|
|Tuscaloosa, Alabama, United States, 35487|
|Contact: Susan White, PhD 205-348-3535 firstname.lastname@example.org|
|Contact: Nicole Powell, PhD 205-348-3535 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Michelle Perrin, MBA 866-647-3436 email@example.com|
|Principal Investigator: Carla Mazefsky, PhD|
|Principal Investigator:||Carla Mazefsky, PhD||University of Pittsburgh|