跳至主要内容
临床试验/NCT06859918
NCT06859918招募中不适用

ASPE Subproject - Training to Understand and Navigate Emotions and Interactions (TUNE In)

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Social Responsiveness Scale (SRS) - Self Report

研究概览

简要总结

The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder.

The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.

The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Meet ASD diagnostic criteria supported by an outside diagnostic evaluation and/or by the clinical and developmental information gathered from a phone screen
  • Be willing to complete screening surveys (outcome measures)
  • Social Responsiveness Score, Second Edition, self-report SRS survey score of greater than or equal to 60

排除标准

  • Severe self-injurious or aggressive behaviors; or with suicidal or homicidal ideation or behaviors (e.g. suicide attempt) within the last 6 months
  • Major mood episode (major depressive episode, manic episode), psychotic symptoms, or a psychiatric hospitalization within the last 6 months
  • A history of intellectual disability or low Shipley-2 score

研究组 & 干预措施

Delay Start Group

Other

The Delay Start Group receives the intervention 1-6 months after the Immediate Start Group.

干预措施: TUNE In: Training to Understand and Navigate Emotions and Interactions (Behavioral)

Immediate Start Group

Experimental

The Immediate Start Group receives the intervention as soon as the trial starts.

干预措施: TUNE In: Training to Understand and Navigate Emotions and Interactions (Behavioral)

结局指标

主要结局

Social Responsiveness Scale (SRS) - Self Report

时间窗: From enrollment to 6 months follow up

A 65 item self-report measure that identifies the presence and severity of social impairment within the autism spectrum.

次要结局

  • Social Responsiveness Scale (SRS) - Informant Report(From enrollment to 6 months follow up)
  • CAT-Q - Camouflaging Autistic Traits Questionnaire(From enrollment to 6 months follow up)
  • Five Facet Mindfulness Questionnaire(From enrollment to 6 months follow up)
  • Glasgow Sensory Questionnaire(From enrollment to 6 months follow up)
  • Generalized Anxiety Disorder-7(From enrollment to 6 months follow up)
  • Insomnia Severity Inde(From enrollment to 6 months follow up)
  • Inventory of Socially Supportive Behaviors(From enrollment to 6 months follow up)
  • Social Network Index(From enrollment to 6 months follow up)
  • Scales of Psychological Wellbeing(From enrollment to 6 months follow up)
  • Attunement Quiz(From enrollment to 6 months follow up)
  • Liebowitz Social Anxiety Scale - Self-Report(From enrollment to 6 months follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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