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Social SkillsASSETNCT06535191

The ASSET Program for Youth With ASD

A study testing Assistive Soft Skills and Employment Training (ASSET) in people with Social Skills and Transition, run by Michigan State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 22 years
What is being tested?
Assistive Soft Skills and Employment Training (ASSET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
18 Dec 2018to 22 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Michigan State University

    East Lansing, Michigan, 48824

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Assistive Soft Skills and Employment Training (ASSET)
Keywords
Soft Skills, Work-related Social Skills, Autism Spectrum Disorder, School-to-work Transition, Vocational Rehabilitation, Employment
Medical subject headings
Social Skills, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assistive Soft Skills and Employment Training (ASSET)Behavioural

    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.

Study groups in NCT06535191
Study groupRoleWhat they receive
ASSET InterventionExperimentalParticipants 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.
Receives: Behavioral: Assistive Soft Skills and Employment Training (ASSET)
Treatment As UsualNo interventionParticipants in the treatment-as-usual is considered as control group and received typical education program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Secondary outcomes (6)
  1. Adaptive Functioning

    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.

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

  2. Psychosocial Functioning

    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.

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

  3. Work Readiness

    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.

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

  4. Anxiety

    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.

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

  5. Depression

    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.

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

  6. Life Satisfaction

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start18 Dec 2018
  3. Primary completion22 May 2023
  4. Study completion22 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
The study uses a factorially designed randomized controlled trial \[2 conditions (treatment vs. waitlist) x 3 intervals pre-, post-, 3-month follow-up\].
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06535191
Sponsor's protocol ID
STUDY00000097
Acronym
ASSET
Status last verified
Jul 2024
First submitted
15 Jul 2024
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Assistive Soft Skills and Employment Training (ASSET) in people with Social Skills and Transition, run by Michigan State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Functioning (time frame: Pre-intervention, immediately post-intervention, 3-month post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

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