Recruiting

Emotion Regulation Therapy

Sponsor:

Michal Assaf

Code:

NCT05341505

Conditions

Autism

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Emotion Regulation Intervention

Study Details

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.

Conditions

Autism

Study ID

NCT05341505

Start date

Jul 15, 2022

Status verified date

Oct, 2022

Completion date

Jan 30, 2023

Anticipated

Primary completion date

Jan 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ER intervention

Cognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks.

Interventions

Emotion Regulation Intervention

We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.

Primary outcome measure

  • Adult Self Report (ASR) [ Time Frame: Baseline ]
  • Adult Self Report (ASR) [ Time Frame: 8 weeks ]
  • Adult Self Report (ASR) [ Time Frame: 2 months follow-up ]
  • Adult Behavior Checklist (ABC-L) [ Time Frame: Baseline ]
  • Adult Behavior Checklist (ABC-L) [ Time Frame: 8 weeks ]
  • Adult Behavior Checklist (ABC-L) [ Time Frame: 2 months follow-up ]

Central Contacts and Locations

Locations

Institute of Living, Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Michal Assaf, MD

860-545-7792michal.assaf@hhchealth.org

Principal Investigator:

Michal Assaf, MD

More Information

Sponsor

Michal Assaf

Last update posted

Oct 14, 2022

Last verified

Oct, 2022

Keywords

  • Emotion regulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Michal Assaf on 2022-10-14.