NCT06535191

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

4.4 years

First QC Date

July 15, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

Soft SkillsWork-related Social SkillsAutism Spectrum DisorderSchool-to-work TransitionVocational RehabilitationEmployment

Outcome Measures

Primary Outcomes (6)

  • Social Functioning

    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

  • Social Responsiveness

    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

  • Work Behaviors

    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

  • Social Self-efficacy

    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

  • Empathic Self-efficacy

    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

  • Job Self-efficacy

    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

Secondary Outcomes (6)

  • 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

  • Depression

    Pre-intervention, immediately post-intervention, 3-month post-intervention

  • +1 more secondary outcomes

Study Arms (2)

ASSET Intervention

EXPERIMENTAL

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.

Behavioral: Assistive Soft Skills and Employment Training (ASSET)

Treatment As Usual

NO INTERVENTION

Participants in the treatment-as-usual is considered as control group and received typical education program.

Interventions

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.

ASSET Intervention

Eligibility Criteria

Age14 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Social SkillsAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Connie Sung, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: The study uses a factorially designed randomized controlled trial \[2 conditions (treatment vs. waitlist) x 3 intervals pre-, post-, 3-month follow-up\].
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2024

First Posted

August 2, 2024

Study Start

December 18, 2018

Primary Completion

May 22, 2023

Study Completion

May 22, 2023

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations