Clinical trial NCT06535191: The ASSET Program for Youth With ASD
Official title: Evaluating an Employment-related Social Skills Training Program for Transition-Age Youth With Autism (The ASSET Program): A Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Skills
Transition
Autism Spectrum Disorder
Confidence, Self
Keywords: Soft Skills
Work-related Social Skills
Autism Spectrum Disorder
School-to-work Transition
Vocational Rehabilitation
Employment
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Illinois Institute of Technology
First posted: 2024-08-02
Enrollment: 85
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study uses a factorially designed randomized controlled trial \[2 conditions (treatment vs. waitlist) x 3 intervals pre-, post-, 3-month follow-up\].
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. aged between 14-22 years of age;
2. 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);
3. exhibit social problems as reported by self or caregiver.

Exclusion Criteria:

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

Primary outcomes:
measure: Social Functioning
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Social Responsiveness
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Work Behaviors
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Social Self-efficacy
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Empathic Self-efficacy
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Job Self-efficacy
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
Secondary outcomes:
measure: Adaptive Functioning
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Psychosocial Functioning
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Work Readiness
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Anxiety
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Depression
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
measure: Life Satisfaction
timeFrame: Pre-intervention, immediately post-intervention, 3-month post-intervention
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Connie Sung, PhD
role: PRINCIPAL_INVESTIGATOR
References: