Outcomes of Emotion Regulation Therapy in Young Autistic Adults

NCT ID: NCT05341505

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2023-01-30

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.

Conditions

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Autism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ER intervention

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

Group Type EXPERIMENTAL

Emotion Regulation Intervention

Intervention Type BEHAVIORAL

We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.

Interventions

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Emotion Regulation Intervention

We will administer a cognitive-behavioral treatment targeting emotion dysregulation, including mindfulness skills and other cognitive and behavioral emotion regulation skills.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michal Assaf

OTHER

Sponsor Role lead

Responsible Party

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Michal Assaf

Director, Autism & Functional Mappin lab

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Institute of Living, Hartford Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Michal Assaf, MD

Role: primary

860-545-7792

Other Identifiers

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R-HHC-2017-0161

Identifier Type: -

Identifier Source: org_study_id

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