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Outcomes of Emotion Regulation Therapy in Young Autistic Adults

Sponsor
Michal Assaf (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05341505
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
9.2
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Emotion Regulation Intervention
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study
Anticipated Study Start Date :
Apr 25, 2022
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adult Self Report (ASR) [Baseline]

    Externalizing and internalizing composite scores

  2. Adult Self Report (ASR) [8 weeks]

    Externalizing and internalizing composite scores

  3. Adult Self Report (ASR) [2 months follow-up]

    Externalizing and internalizing composite scores

  4. Adult Behavior Checklist (ABC-L) [Baseline]

    Externalizing and internalizing composite scores

  5. Adult Behavior Checklist (ABC-L) [8 weeks]

    Externalizing and internalizing composite scores

  6. Adult Behavior Checklist (ABC-L) [2 months follow-up]

    Externalizing and internalizing composite scores

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Living, Hartford Hospital Hartford Connecticut United States 06106

Sponsors and Collaborators

  • Michal Assaf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michal Assaf, Director, Autism & Functional Mappin lab, Hartford Hospital
ClinicalTrials.gov Identifier:
NCT05341505
Other Study ID Numbers:
  • R-HHC-2017-0161
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michal Assaf, Director, Autism & Functional Mappin lab, Hartford Hospital
Emotion regulation
Additional relevant MeSH terms:
Autistic Disorder

Study Results

No Results Posted as of Apr 22, 2022