NCT03432832Completed
Emotion Awareness and Skills Enhancement Program
Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 Apr 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 113 (actual)
- First submitted
- 17 Jan 2018
- Start date
- 30 Jan 2018
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- University of Pittsburgh
- Diseases
- Autism
- NCT number
- NCT03432832
What you commit to
- Study type: Interventional
- Participants enrolled: 113
- From 30 Jan 2018 to the primary completion date, 30 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
Who the study is looking for
- 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.
Age in the registry: 12 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shannondora Porton Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of Alabama Coordinator of this site? Confirm its status | Tuscaloosa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.