Skip to main content
Clinical Trials/NCT05341505
NCT05341505
Recruiting
Not Applicable

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

Michal Assaf1 site in 1 country5 target enrollmentJuly 15, 2022
ConditionsAutism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Michal Assaf
Enrollment
5
Locations
1
Primary Endpoint
Adult Self Report (ASR)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
January 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Michal Assaf
Responsible Party
Sponsor Investigator
Principal Investigator

Michal Assaf

Director, Autism & Functional Mappin lab

Hartford Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Adult Self Report (ASR)

Time Frame: 2 months follow-up

Externalizing and internalizing composite scores

Adult Behavior Checklist (ABC-L)

Time Frame: 2 months follow-up

Externalizing and internalizing composite scores

Study Sites (1)

Loading locations...

Similar Trials