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临床试验/NCT05341505
NCT05341505招募中不适用

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

Michal Assaf2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2022年7月15日最近更新:
适应症

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
2
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

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

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

次要结局

未报告次要终点

研究者

发起方
Michal Assaf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michal Assaf

Director, Autism & Functional Mappin lab

Hartford Hospital

研究点 (2)

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