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Behavioral Intervention

Emotion Regulation Therapies for Autism

N/A
Recruiting
Led By Carla Mazefsky, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post trial (4 years)
Awards & highlights

Study Summary

This trial will compare two interventions to help autistic people improve emotion regulation, to see if one specifically designed for them is superior in reducing mental health difficulties.

Who is the study for?
This trial is for autistic youth and young adults who have difficulty regulating emotions, as indicated by specific scores on the EDI-Reactivity or Dysphoria scale. Participants must have a professional ASD diagnosis, be able to take part meaningfully, and benefit from the study. They need an adult who can complete assessments and live in Alabama or Pennsylvania with internet access for online activities.Check my eligibility
What is being tested?
The trial compares two emotion regulation therapies: The Emotion Awareness and Skills Enhancement Program designed specifically for autistic individuals, versus The Unified Protocol. It aims to determine which intervention is more effective when implemented through community agencies.See study design
What are the potential side effects?
Since these interventions are therapy-based focusing on emotion regulation skills without medication involvement, traditional physical side effects are not expected. However, participants may experience emotional discomfort or increased anxiety during sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post trial (4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post trial (4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Emotion Dysregulation Inventory
Provider Self-Efficacy Scale
Weiner's Acceptability, Appropriateness, & Feasibility of Intervention Scales
Secondary outcome measures
AASPIRE Burnout Scale Short Form
AASPIRE Flourishing Scale
AASPIRE Patient Health Questionnaire-9
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: The Emotion Awareness and Skills EnhancementExperimental Treatment1 Intervention
EASE is a 16-session mindfulness-based intervention (MBI). It emphasizes a small set of core concepts (i.e., mindfulness practices, distress tolerance, encouraging helpful thoughts, self-compassion) that are repeated with consistent language throughout. Emphasis is placed on increasing awareness of gradients of emotional arousal.
Group II: The Unified ProtocolActive Control1 Intervention
UP is a 12-21 session cognitive behavioral therapy (CBT) based treatment. In this study, there will be 16 sessions. UP is focused on identifying emotions and building new coping strategies. It is customizable to meet the needs of the individual.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,732 Previous Clinical Trials
16,306,702 Total Patients Enrolled
University of Alabama, TuscaloosaOTHER
45 Previous Clinical Trials
19,157 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
556 Previous Clinical Trials
29,947,336 Total Patients Enrolled
~313 spots leftby Aug 2027
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