Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
University of Pittsburgh
Study ID
NCT06158581
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • The Emotion Awareness and Skills Enhancement Program — BEHAVIORAL
    EASE is a cutting-edge program created by researchers at the University of Alabama and the University of Pittsburgh in collaboration with autistic individuals, caregivers of autistic youth, and therapists. The overarching goal of the program is to support autistic clients who want to work on emotion regulation. EASE is unique because it targets emotional distress in autistic youth and adults, instead of targeting the core symptoms of autism (i.e., it is not a social skills intervention). The program is a 16-session, mindfulness-based intervention. Each session is 1:1 for 45 minutes to one hour. While the program is designed for individual intervention, caregivers are also invited to play an active role on the care team.
  • The Unified Protocol — BEHAVIORAL
    UP is a thoroughly-studied, manualized intervention created by researchers at the University of Miami in conjunction with researchers at Boston University. The program was designed to be customizable to meet the needs of people with a variety of diagnoses, allowing more individuals to access emotion regulation resources. The protocol also has different modules to accommodate different developmental levels (UP-Children, UP-Adolescent, UP-Adult). The overall goal of UP is to help clients identify emotions and build new strategies to cope with stressful life situations and distressing emotions. The protocol is flexible, with each session is about 45 to 60 minutes and the number of sessions varying between 12 - 21 sessions. For the current study, the treatment will take place over 16 sessions. The intervention is cognitive behavioral therapy (CBT) based but also includes hints of mindfulness-based intervention strategies.

Study Details

Too few clinicians are able and willing to help autistic patients. A recent review identified challenges to mental health service delivery in autism, including a lack of interventions designed for community implementation and limited workforce capacity. It has been argued that improving impairment in emotion regulation has the potential to improve a range of mental health difficulties in autistic people. In this clinical trial, the investigators are comparing two evidence-based interventions for emotion regulation, to determine if one created specifically for autistic people is clinically superior. The interventions will be implemented in the community, through partnering agencies.

Key Dates

Start date
Apr 8, 2024
Status verified
Apr 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
470 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: The Emotion Awareness and Skills Enhancement
    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.
  • Active Comparator: The Unified Protocol
    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.

Primary Outcome Measure

Emotion Dysregulation Inventory [ Time Frame: Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of AlabamaTuscaloosaAlabama35401
Madison Bradley
[email protected]
205-348-2472
University of PittsburghPittsburghPennsylvania15213
Kara L Duman, MSW
[email protected]
1-866-647-3436

Find similar trials in Tuscaloosa, AL

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University of Alabama· Tuscaloosa, ALUniversity of Pittsburgh· Pittsburgh, PA

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