Outcomes of Emotion Regulation Therapy in Young Autistic Adults

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341505
• Other study ID #: R-HHC-2017-0161
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: October 2022
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Institute of Living, Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Michal Assaf

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult Self Report (ASR)	Externalizing and internalizing composite scores	Baseline
Primary	Adult Self Report (ASR)	Externalizing and internalizing composite scores	8 weeks
Primary	Adult Self Report (ASR)	Externalizing and internalizing composite scores	2 months follow-up
Primary	Adult Behavior Checklist (ABC-L)	Externalizing and internalizing composite scores	Baseline
Primary	Adult Behavior Checklist (ABC-L)	Externalizing and internalizing composite scores	8 weeks
Primary	Adult Behavior Checklist (ABC-L)	Externalizing and internalizing composite scores	2 months follow-up