跳至主要内容
临床试验/NCT06552286
NCT06552286招募中不适用

A Multisite RCT of a Daily Living Skills Intervention for Autistic Adolescents Prior to the Transition to Adulthood

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2024年7月10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
192
试验地点
2
主要终点
Vineland Adaptive Behavior Scales, 3rd Edition

研究概览

简要总结

The current study seeks to compare outcomes of a telehealth intervention targeting daily living skills (Surviving and Thriving in the Real World - Telehealth, or STRW-T) intervention to a control group telehealth intervention targeting social skills (Program for the Education and Enrichment of Relational Skills- Telehealth, or PEERS-T). The key endpoint will be change in daily living skills on primary and secondary outcome measures at the end of treatment.

详细描述

Individuals with high functioning autism spectrum disorder (ASD) are not developing the skills necessary to successfully transition from adolescence to college, employment, and independent living.

Daily living skills (DLS) have been linked to positive adult outcome in individuals with ASD.

Despite the importance of daily living skills to adult outcome, adolescents with high functioning ASD have impaired daily living skills.

A complex set of environmental, individual, and family factors likely affect the ability of adolescents with high functioning ASD to acquire critical daily living skills.

There are currently no evidence-based daily living skills intervention packages for adolescents with high functioning ASD that would prepare them for independence in adulthood.

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
Single (Outcomes Assessor)

盲法说明

Coordinator who is assessing goals of participants is masked from knowing which group each participant was randomized to.

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • in the last 2 years of high school, or deferring graduation
  • diagnosis of ASD based on clinical judgement and/or meeting the cut-off score on the Autism Diagnostic Observation Schedule, 2nd Edition
  • full scale IQ of 70 or above as measured by the Wechsler Abbreviated Scale of Intelligence, 2nd Edition
  • deficient Daily Living Skills as assessed by the Vineland Adaptive Behavior Scales, 3rd Edition - at least 1 of the 3 Daily Living Skills subdomains is at least 15 points below their full scale IQ

排除标准

  • significant aggressive behaviors or mental health issues that require treatment out of the scope of the current intervention.
  • if the adolescent has already completed the social skills group (PEERS), either at Cincinnati Children's or in another setting, unless it has been a significant amount of time since they did the PEERS group (2-3 years, or up to the discretion of the PI).

研究组 & 干预措施

Surviving and Thriving in the Real World - Telehealth (STRW-T)

Experimental

randomized to STRW-T intervention

干预措施: STRW-T (Behavioral)

Program for the Education and Enrichment of Relational Skills - Telehealth (PEERS-T)

Active Comparator

randomized to PEERS-T intervention

干预措施: PEERS-T (Behavioral)

结局指标

主要结局

Vineland Adaptive Behavior Scales, 3rd Edition

时间窗: 4 months

The VABS-3 is a well-established standardized measure of adaptive behavior that assesses skills in the Communication, Daily Living Skills, and Socialization domains. The DLS domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention. Subdomain v-scale scores: 1 to 24. Domain and Adaptive Behavior Composite Standard Scores: 20 to 140. The higher the score, the better the adaptive level. V-scale scores have a mean of 15 and standard deviation (SD) of 3. Standard scores have a mean of 100 and SD of 15.

次要结局

  • Adaptive Behavior Assessment System, Third Edition(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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