- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06535191
The ASSET Program for Youth With ASD (ASSET)
Evaluating an Employment-related Social Skills Training Program for Transition-Age Youth With Autism (The ASSET Program): A Randomized Controlled Trial Study
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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East Lansing, Michigan, United States, 48824
- Michigan State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- have a co-occurring intellectual disability;
- have other neurological disorders or severe psychiatric disabilities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: ASSET Intervention
Participants in the intervention group received Assistive Soft Skills and Employment Training (ASSET), a 10-week manualized soft skills intervention program to help students with ASD improve social and adaptive functioning, self-efficacy, work readiness, and anxiety.
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ASSET program is a manualized, theory-driven, 10-week soft skills intervention for autistic individuals, who seek employment or who wish to maintain employment by improving work-related social skills.
Throughout a 10-week curriculum offered in a school-based group setting, ASSET addresses the following competencies for workplace success: Communication, Networking, Enthusiasm and Attitude, Teamwork, Problem-Solving and Critical Thinking, Professionalism, Mental Health and Stress Management, and Awareness of Self and Others.
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No Intervention: Treatment As Usual
Participants in the treatment-as-usual is considered as control group and received typical education program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Functioning
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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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. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Social Responsiveness
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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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. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Work Behaviors
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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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. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Social Self-efficacy
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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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. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Empathic Self-efficacy
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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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. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Job Self-efficacy
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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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. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adaptive Functioning
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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General Adaptive Composite (GAC) score of the Adaptive Behavior Assessment System: Third Edition (ABAS-3) was used to assess participants' changes in adaptive functioning skills. Raw Scores: Each item within the domains 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 domain, which include (1) Conceptual: communication, functional academics, and self-direction; (2) Social: Includes social skills and leisure; (3) Practical: Includes self-care, home living, community use, health and safety, and work. Scaled Scores: Raw scores are converted to scaled scores for each domain. 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 domains are combined to form the GAC, with a mean of 100 and a standard deviation of 15, with a higher score indicating high social functioning. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Psychosocial Functioning
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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Score of the Behavior Assessment System for Children: Third Edition (BASC-3) was used to assess participants' changes in adaptive functioning skills. Raw Scores: Each item within the domains 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 subscale, which include (1) Anxiety; (2) Depression; (3) Withdrawal; (4) Adaptability; (5) Leadership; (6) Executive Functioning; (7) Resiliency. 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 psychosocial impairment. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Work Readiness
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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Scaled score of the Stages of Change-Work Participation Scale (SCWPS) was used to assess participants' changes in work readiness. Raw Scores: Each item is rated on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (strongly agree), and the scores are summed for items corresponding to each stage of change. Stage Classification: The sum of scores within each stage helps classify the individual's current stage of readiness for change in work participation. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Anxiety
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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Total score of the General Anxiety Disorder-7 (GAD-7) was used to assess participants' changes in anxiety symptoms. Items are rated on a 4-point Likert scale, ranging from 0 (Not at all) to 3 (Nearly everyday). Sum the scores for all 7 items to obtain the total score. Total score ranges from 0 to 21, with a higher score indicating higher anxiety. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Depression
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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Total score of the Patient Health Questionnaire-9 (PHQ-9) was used to assess participants' changes in depressive symptoms. Items are rated on a 4-point Likert scale, ranging from 0 (Not at all) to 3 (Nearly everyday). Sum the scores for all 9 items to obtain the total score. Total score ranges from 0 to 27, with a higher score indicating higher depression. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Life Satisfaction
Time Frame: Pre-intervention, immediately post-intervention, 3-month post-intervention
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Total score of the Satisfaction With Life Scale (SWLS) was used to participants' changes in life satisfaction. Items are rated on a 7-point Likert scale, ranging from 1 (Strongly disagree) to 5 (Strongly agree). Sum the scores for all 5 items to obtain the total score. Total score ranges from 5 to 35, with higher score indicating higher depression. |
Pre-intervention, immediately post-intervention, 3-month post-intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Connie Sung, PhD, Michigan State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000097
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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