Outcomes of Emotion Regulation Therapy in Young Autistic Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism

Intervention / Treatment
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* Behavioral: Emotion Regulation Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ER intervention<br>Cognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks. | Behavioral: Emotion Regulation Intervention<br>* We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotion regulation