Outcomes of Emotion Regulation Therapy in Young Autistic Adults
Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedOctober 14, 2022
October 1, 2022
7 months
March 24, 2022
October 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Adult Self Report (ASR)
Externalizing and internalizing composite scores
Baseline
Adult Self Report (ASR)
Externalizing and internalizing composite scores
8 weeks
Adult Self Report (ASR)
Externalizing and internalizing composite scores
2 months follow-up
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores
Baseline
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores
8 weeks
Adult Behavior Checklist (ABC-L)
Externalizing and internalizing composite scores
2 months follow-up
Study Arms (1)
ER intervention
EXPERIMENTALCognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks.
Interventions
We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michal Assaflead
Study Sites (1)
Institute of Living, Hartford Hospital
Hartford, Connecticut, 06106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Autism & Functional Mappin lab
Study Record Dates
First Submitted
March 24, 2022
First Posted
April 22, 2022
Study Start
July 15, 2022
Primary Completion
January 30, 2023
Study Completion
January 30, 2023
Last Updated
October 14, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share