Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Adult Self Report (ASR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
ER intervention
Cognitive-behavioral emotion regulation intervention administered twice weekly for 8 weeks.
干预措施: Emotion Regulation Intervention (Behavioral)
结局指标
主要结局
Adult Self Report (ASR)
时间窗: 2 months follow-up
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
时间窗: 2 months follow-up
Externalizing and internalizing composite scores
Adult Self Report (ASR)
时间窗: 8 weeks
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
时间窗: Baseline
Externalizing and internalizing composite scores
Adult Self Report (ASR)
时间窗: Baseline
Externalizing and internalizing composite scores
Adult Behavior Checklist (ABC-L)
时间窗: 8 weeks
Externalizing and internalizing composite scores
次要结局
未报告次要终点
研究者
Michal Assaf
Director, Autism & Functional Mappin lab
Hartford Hospital