Outcomes of Emotion Regulation Therapy in Young Autistic Adults

Not Applicable

Recruiting

• Conditions: Autism
• Interventions: Behavioral: Emotion Regulation Intervention

• Registration Number: NCT05341505
• Lead Sponsor: Michal Assaf

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.

Study Timeline

• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-22
• Study Start: 2022-07-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ER intervention	Emotion Regulation Intervention	Cognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Adult Self Report (ASR)	2 months follow-up	Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)	2 months follow-up	Externalizing and internalizing composite scores

Trial Locations

Locations (1)

Institute of Living, Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States