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临床试验/NCT06535191
NCT06535191已完成不适用

Evaluating an Employment-related Social Skills Training Program for Transition-Age Youth With Autism (The ASSET Program): A Randomized Controlled Trial Study

Michigan State University2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2018年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
2
主要终点
Work Behaviors

研究概览

简要总结

The purpose of this project is to evaluate the effectiveness of a work-related social skills training intervention for transition-age youth with Autism Spectrum Disorder (ASD; ages 14-22) that is designed to improve social skills, social self-efficacy, adaptive functioning, anxiety and work readiness. The Assistive Social Skills & Employment Training (ASSET) program is a weekly after-school program that runs for 10 weeks. In the first part of the study, youth with ASD, caregivers, special education teachers and employment specialists are invited to review and provide recommendations to improve the manual that has been developed for the ASSET program. The second part of the study is to evaluate the impact of the ASSET program on helping students with ASD improve their social skills, social self-efficacy, adaptive functioning, anxiety and work readiness using a randomized control trial. Improvements in these domains will be assessed immediately following the 10-week program and 3 months later. The intervention will occur at multiple sites in Michigan and Illinois, with a total of 96 students with autism. The ASSET program addresses the employment disparities faced by young adults with ASD by specifically targeting work-related social skills through the development of social skills and self-efficacy to foster successful school-to-work transition outcomes. The manualized ASSET program curriculum will eventually be made public and available for schools and service providers to use.

详细描述

Objective/Hypotheses: The objective of the randomized controlled trial (RCT) study is to evaluate the effectiveness of a manualized work-related social skills training intervention for transition-age youth (14-26 years old) with ASD designed to improve social skills and self-efficacy. The Assistive Social Skills and Employment Training (ASSET) program is a manualized 10-week program for 4-6 students with ASD that meets after school for 90 minutes on a weekly basis focusing on building work-related social skills for transition-age youth with ASD. It is hypothesized that students with ASD will show significantly greater improvements in social skills and social self-efficacy (primary outcomes) as well as adaptive functioning, anxiety and job readiness (secondary outcomes) compared to those in the waitlist control groups (a) at the end of the 10-week of the intervention and (b) at 3-month follow up.

Specific aims: First, the pilot-tested ASSET manual will be refined and finalized using community-based participatory action research (CBPR) approach gathering input from key stakeholder groups. Second, the effectiveness and sustainability of the ASSET program will be evaluated using a factorially designed randomized controlled trial [2 conditions (treatment vs. waitlist) x 3 intervals pre-, post-, 3-month follow-up].

Study Design: The first stage of this project incorporates stakeholder recommendations using a CBPR approach to refine the manual for the ASSET intervention. The second and third stages examine the efficacy of the ASSET program at immediate and follow-up using a randomized control trial design in two Midwestern states with randomization of student participants by condition for each of the two states, with a total of 4 treatment cycles over years 2 and 3 of the four-year study period, including 3-month follow-up after the completion of the 10-week program. Participants will include 96 students (age 14-22) from schools in Michigan and Illinois who will be randomly assigned to either the ASSET intervention or waitlist-control condition.

Clinical Impact: This project will fill an important gap for schools, transition providers, families and students, by testing an intervention designed to specifically improve the social functioning and self-efficacy of youth with ASD to improve work-related success. The findings will provide an empirically supported intervention manual to help students with ASD improve social and adaptive functioning, self-efficacy, work readiness, and anxiety.

研究设计

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

入排标准

年龄范围
14 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • aged between 14-22 years of age;
  • have a diagnosis of autism without intellectual disabilities (i.e., autistic disorders, Asperger's syndrome, PDD-NOS, Rett's syndrome, Childhood Disintegrative Disorder according to DSM-IV or Autism Spectrum Disorder according to DSM 5);
  • exhibit social problems as reported by self or caregiver.

排除标准

  • have a co-occurring intellectual disability;
  • have other neurological disorders or severe psychiatric disabilities.

结局指标

主要结局

Work Behaviors

时间窗: Pre-intervention, immediately post-intervention, 3-month post-intervention

Subscale scores of the Job Observation and Behavior Scale (JOBS) was used to assess participants' changes in work readiness and behaviors. Raw Scores: Each item is rated on a Likert scale. Individual item scores are summed to create raw scores for various subscales, which include (1) Work Quality, (2) Work Quantity, (3) Work Attitudes, (4) Social Skills, (5) Personal Presentation, and (6) Adaptability. Composite Scores: Raw scores from the subscales are combined to form composite scores (i.e., Quality of performance and Type of support), with a higher composite score indicating better performance, more positive work behaviors, less support/assistance needed.

Social Self-efficacy

时间窗: Pre-intervention, immediately post-intervention, 3-month post-intervention

Score of Perceived Social Self-Efficacy (PSSE) was used to assess participants' changes in perceived social self-efficacy. It is scored using a 5-point Likert scale, ranging from 1 (Not well at all) to 5 (Very well). The overall range of possible scores is 6 to 30, with a higher score indicating a higher level of social self-efficacy.

Social Functioning

时间窗: Pre-intervention, immediately post-intervention, 3-month post-intervention

Social composite score of the Adaptive Behavior Assessment System: Third Edition (ABAS-3) was used to assess participants' changes in social functioning. Raw Scores: Each item within the Social Skills subdomains is rated on a 4-point Likert scale, ranging from 0 (Never) to 3 (Always). The ratings are summed to produce raw scores for each subdomain. Scaled Scores: Raw scores are converted to scaled scores for Social Skills subdomain. Scaled scores typically range from 1 to 19, with a mean of 10 and a standard deviation of 3. Composite Score: The scaled scores from the Social Skills subdomains are combined to form the Social Composite Score, with a mean of 100 and a standard deviation of 15, with a higher score indicating higher social functioning.

Empathic Self-efficacy

时间窗: Pre-intervention, immediately post-intervention, 3-month post-intervention

Score of Perceived Empathic Self-Efficacy (PESE) was used to assess participants' changes in perceived empathic self-efficacy. It is scored using a 5-point Likert scale, ranging from 1 (Not well at all) to 5 (Very well). The overall range of possible scores is 5 to 25, with a higher score indicating a higher level of empathic self-efficacy.

Social Responsiveness

时间窗: Pre-intervention, immediately post-intervention, 3-month post-intervention

Total score of the Social Responsiveness Scale: Second Edition (SRS-2) was used for measuring social responsiveness. Raw Scores: Each item is rated on a 4-point Likert scale, ranging from 0 (Never True) to 3 (Almost Always True). Raw scores are summed for each subscale and for the total scale. Subscales include: (1) Social Awareness; (2) Social Cognition; (3) Social Communication; (4) Social Motivation; and (5) Restricted Interests and Repetitive Behaviours. T-Scores: Raw scores are converted to T-scores to facilitate interpretation. T-scores have a mean of 50 and a standard deviation of 10, with a higher score indicating greater severity of social impairment.

Job Self-efficacy

时间窗: Pre-intervention, immediately post-intervention, 3-month post-intervention

Score of Job Self-Efficacy (JSE) was used to assess participants' changes job self-efficacy. Each item is rated on a scale, ranging from 1 (Very much disagree) to 6 (Very much agree). Individual item scores are summed to create a total raw score. Raw scores from the items or subscales are summed to form composite scores, with higher scores indicating greater self-efficacy in job-related tasks.

次要结局

  • Depression(Pre-intervention, immediately post-intervention, 3-month post-intervention)
  • Adaptive Functioning(Pre-intervention, immediately post-intervention, 3-month post-intervention)
  • Psychosocial Functioning(Pre-intervention, immediately post-intervention, 3-month post-intervention)
  • Work Readiness(Pre-intervention, immediately post-intervention, 3-month post-intervention)
  • Anxiety(Pre-intervention, immediately post-intervention, 3-month post-intervention)
  • Life Satisfaction(Pre-intervention, immediately post-intervention, 3-month post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Connie Sung

Professor

Michigan State University

研究点 (2)

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