Outcomes of Emotion Regulation Therapy in Young Autistic Adults

October 12, 2022 updated by: Michal Assaf

Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study

This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Five young adults with ASD with emotional/behavioral challenges that are attributed to emotion dysregulation will be enrolled into an emotion regulation (ER) intervention administered twice weekly for a total of 16 sessions. Participants will be evaluated pre- and post-treatment using behavioral and imaging measures, and at mid-treatment and 2-month follow-up using behavioral measures administered electronically and/or via phone interview.

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Institute of Living, Hartford Hospital
        • Contact:
        • Principal Investigator:
          • Michal Assaf, MD
        • Sub-Investigator:
          • Gretchen Diefenbach, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Disorder
  • Ages 18-40
  • Estimated full-scale IQ ≥ 80
  • T score > 60 on either the externalizing or internalizing symptoms scores of either the Adult Behavior Checklist (ABC-L) or the Adult Self Report (ASR)
  • Participation in previous study at the Olin Center ("Social Emotional Study"; E-HHC- 2018-0241)

Exclusion Criteria:

  • Intellectual disability (estimated full scale IQ<80
  • History of a significant head injury (severe concussion, hospitalization)
  • History of neurosurgery
  • History of epilepsy, stroke, MS, a neurodegenerative disorder, or any other neurological disorder
  • A current major medical condition (e.g. cancer, heart failure)
  • Current substance use (determined by urine screen done to all participants before each MRI scan)
  • In-body metal implants (e.g. surgical clips, certain pacemakers) or history of exposure to metal shards or other MRI contraindications
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ER intervention
Cognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks.
Behavioral: Emotion Regulation Intervention
We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adult Self Report (ASR)
Time Frame: Baseline
Externalizing and internalizing composite scores
Baseline
Adult Self Report (ASR)
Time Frame: 8 weeks
Externalizing and internalizing composite scores
8 weeks
Adult Self Report (ASR)
Time Frame: 2 months follow-up
Externalizing and internalizing composite scores
2 months follow-up
Adult Behavior Checklist (ABC-L)
Time Frame: Baseline
Externalizing and internalizing composite scores
Baseline
Adult Behavior Checklist (ABC-L)
Time Frame: 8 weeks
Externalizing and internalizing composite scores
8 weeks
Adult Behavior Checklist (ABC-L)
Time Frame: 2 months follow-up
Externalizing and internalizing composite scores
2 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michal Assaf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Anticipated)

January 30, 2023

Study Completion (Anticipated)

January 30, 2023

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

April 17, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-HHC-2017-0161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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