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Outcomes of Emotion Regulation Therapy in Young Autistic Adults

Primary Purpose

Autism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion Regulation Intervention
Sponsored by
Michal Assaf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Emotion regulation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Living, Hartford HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ER intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Adult Self Report (ASR)
Externalizing and internalizing composite scores
Adult Self Report (ASR)
Externalizing and internalizing composite scores
Adult Self Report (ASR)
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores

Secondary Outcome Measures

Full Information

First Posted
March 24, 2022
Last Updated
October 12, 2022
Sponsor
Michal Assaf
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1. Study Identification

Unique Protocol Identification Number
NCT05341505
Brief Title
Outcomes of Emotion Regulation Therapy in Young Autistic Adults
Official Title
Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michal Assaf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Emotion regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ER intervention
Arm Type
Experimental
Arm Description
Cognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Emotion Regulation Intervention
Intervention Description
We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.
Primary Outcome Measure Information:
Title
Adult Self Report (ASR)
Description
Externalizing and internalizing composite scores
Time Frame
Baseline
Title
Adult Self Report (ASR)
Description
Externalizing and internalizing composite scores
Time Frame
8 weeks
Title
Adult Self Report (ASR)
Description
Externalizing and internalizing composite scores
Time Frame
2 months follow-up
Title
Adult Behavior Checklist (ABC-L)
Description
Externalizing and internalizing composite scores
Time Frame
Baseline
Title
Adult Behavior Checklist (ABC-L)
Description
Externalizing and internalizing composite scores
Time Frame
8 weeks
Title
Adult Behavior Checklist (ABC-L)
Description
Externalizing and internalizing composite scores
Time Frame
2 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institute of Living, Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Assaf, MD
Phone
860-545-7792
Email
michal.assaf@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Michal Assaf, MD
First Name & Middle Initial & Last Name & Degree
Gretchen Diefenbach, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Outcomes of Emotion Regulation Therapy in Young Autistic Adults

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