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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post trial (4 years)

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

Buss-Perry Aggression Questionnaire

+11 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,723 Previous Clinical Trials

16,342,756 Total Patients Enrolled

University of Alabama, TuscaloosaOTHER

44 Previous Clinical Trials

19,116 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,997,058 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be able to join this experiment?

"This clinical trial is actively searching for 400 individuals with Autism Spectrum Disorder who are between the ages of 12 and 25. To qualify, candidates must meet these requirements."

Answered by AI

Are recruiting efforts still underway for this experiment?

"The information hosted on clinicaltrials.gov reveals no further recruitment is needed for this particular trial; it was initially posted February 15th 2024 and edited November 27th 2023. However, there are 296 additional medical studies that actively seek candidates at the present moment."

Answered by AI

Is the age criterion for this research protocol restricted to adults under 45 years of age?

"Suitable candidates for this medical trial must meet the age requirement of 12-25. Seperate trials are available to those under 18 (247) and over 65 years old (49)."

Answered by AI

What are the chief aims of this experiment?

"This prospective clinical trial, monitored over a 16-20 week period, seeks to measure patients' self-efficacy. Secondary outcomes being evaluated include the AASPIRE Burnout Scale Short Form - a 14 item questionnaire evaluating autistic burnout; Clinical Global Impressions (CGI) - designed to rate overall symptomatic change from baseline; and Credibility and Expectancy Questionnaire – assessing treatment expectancy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

Carla Mazefsky 2024. "Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06158581.

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