- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06829264
Testing an Evidence-Based Supported Employment Model in Autistic Young Adults
A Pilot Trial of the Individualized Placement and Support Model in Autistic Adults in the Community
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study builds on prior research and pilot testing of IPS in the autism and IDD community by implementing a 12-month Hybrid Type 1 trial to evaluate the effectiveness and implementation of IPS-AUT. The current study will include three primary aims:
Consumer Support Toolbox Development: Using data from previous focus groups, researchers will develop and test a Consumer Support Toolbox (CST) to align IPS services with autistic consumer needs.
IPS-AUT Implementation and Outcomes Evaluation: A 12-month Hybrid Type 1 trial will assess feasibility, acceptability, fidelity to IPS standards, and employment outcomes. The study aims for a minimum 50% success rate in Competitive Integrated Employment and at least 75% feasibility and acceptability.
Mediators of Employment Outcomes: Researchers will explore the role of parent/carer engagement and work-related social cognition in improving employment success.
This trial is designed to prepare for a larger R01-funded study by refining implementation strategies and addressing key barriers. Participants will include young adults with autism, their employment providers, and caregivers, with data collected through surveys, focus groups, interviews, and standardized assessments. The study is funded by the National Institute of Mental Health and conducted in collaboration with supported employment agencies in California.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jo A. Yon Hernandez, PhD
- Phone Number: 9162674459
- Email: jyonh@ucdavis.edu
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- Recruiting
- University of California, Davis MIND Institute
-
Contact:
- Jo Ann Yon Hernandez, PhD
- Phone Number: 916-703-0389
- Email: jyonh@health.ucdavis.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: California supported employment agency clients meeting the following criteria:
- Community diagnosis of autism spectrum disorder, demonstrated by a letter from a healthcare provider, psychologist, other mental health professional, Regional Center representative, or school psychologist.
- Aged 18-40 years.
- Minimum 4th-grade reading level (approximately mild ID).
- Not currently employed but seeking employment.
Exclusion Criteria:
- Not interested in employment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group - Agencies Receiving IPS
Participating agencies will be randomized, with 2/3 of agencies receiving IPS first.
The estimated total number of agencies = 6 (each referring 10 consumers), meaning that 4 agencies (40 clients) would be assigned to receive IPS training first.
These agencies will be expected to deliver IPS services for a duration of 12 months.
|
The Individualized Placement and Support (IPS) model is an evidence-based approach to supported employment designed to help individuals with disabilities achieve and maintain competitive integrated employment (CIE).
IPS emphasizes person-centered planning, rapid engagement, and focusing on individual strengths and preferences.
Key features include prioritizing CIE, eligibility based on the desire to work, integration of employment services with mental health support, rapid job searches, tailored job development, and time-unlimited, individualized support.
IPS also provides benefits counseling to help participants manage employment while maintaining government benefits.
For this study, IPS is adapted to meet the needs of autistic individuals by enhancing provider training and family involvement to improve outcomes.
|
|
Active Comparator: Control Group - Agencies Receiving Supportive Employment Intervention
One third of the agencies (approximately 2 agencies and 20 consumers) will be assigned to the wait-list control group will continue to provide their usual services during the first 12 months.
In addition, clients of these agencies will be offered a Supportive Employment Intervention, which includes weekly sessions offering support with some help on employment-related skills such as resume building, job interviewing, and workplace communication strategies.
|
This intervention consists of a weekly series of sessions designed for adult consumers, incorporating supportive elements inspired by the ACCESS (Acquiring Career, Coping, Executive, and Social Skills) program developed at the UC Davis MIND Institute.
The sessions will provide time to discuss consumer experiences, give general guidance and some training in employment-related skills, including resume building, job interviewing, and strategies for giving and receiving feedback in the workplace.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of IPS Implementation
Time Frame: 18 months
|
Measure: Agency feasibility ratings and IPS fidelity reviews. Assessment Method: Trained IPS fidelity reviews will assess fidelity using the IPS Fidelity Scale (Bond et al., 2012) at baseline, 6 months, and 12 months. Additionally, feasibility will be assessed through participant, parent, and provider ratings on a 5-point Likert scale (1 = not feasible at all, 5 = highly feasible). Expect outcome: Achieve good fidelity at the 12-month fidelity review. Achieve at least 75% feasibility. |
18 months
|
|
Acceptability of IPS Implementation
Time Frame: 18 months
|
Measure: Participant, parent, and provider satisfaction. Assessment Method: Surveys using a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied) to assess satisfaction with IPS services and overall perceived value of the intervention. Expect outcome: Achieve at least 75% acceptability. |
18 months
|
|
Competitive Integrated Employment (CIE) Attainment
Time Frame: 18 months
|
Measure: CIE attainment log Assessment Method: Monthly reports on employment status will be collected via phone or in virtual meetings with providers.
Employment status will be categorized as "Employed in CIE," "Not Employed," or "Transitioned Out of CIE." Expect outcome: Minimum of 50% CIE attainment success.
|
18 months
|
|
Competitive Integrated Employment (CIE) Retention
Time Frame: 18 months
|
Measure: CIE retention log Assessment Method: Monthly reports on employment status will be collected via phone or in virtual meetings with providers.
Employment status will be verified as "Employed in CIE," "Not Employed," or "Transitioned Out of CIE." Expect outcome: Minimum of 50% CIE retention.
|
18 months
|
|
Parent/Carer Engagement
Time Frame: 18 months
|
Measure: Family Engagement Survey Assessment Method: Monthly surveys will be collected via phone or online to collect information on family involvement and satisfaction with the services their family member is receiving.
Family members/carers will rate their involvement and satisfaction on a Likert scale survey.
|
18 months
|
|
Work-Related Social Cognition
Time Frame: 18 months
|
Work-related social cognition is evaluated to understand its impact on functional outcomes such as planning, problem-solving, and attention, which are critical to employment success. Assessment Method: The Adult Behavior Rating Inventory of Executive Function (BRIEF-2A) will be used to measure these cognitive abilities. |
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marjorie Solomon, PhD, MBA, University of California, Davis
Publications and helpful links
General Publications
- Bond GR, Drake RE, Becker DR. Generalizability of the Individual Placement and Support (IPS) model of supported employment outside the US. World Psychiatry. 2012 Feb;11(1):32-9. doi: 10.1016/j.wpsyc.2012.01.005.
- Drake RE, Bond GR, Goldman HH, Hogan MF, Karakus M. Individual Placement And Support Services Boost Employment For People With Serious Mental Illnesses, But Funding Is Lacking. Health Aff (Millwood). 2016 Jun 1;35(6):1098-105. doi: 10.1377/hlthaff.2016.0001.
- Bond GR, Becker DR, Drake RE, Rapp CA, Meisler N, Lehman AF, Bell MD, Blyler CR. Implementing supported employment as an evidence-based practice. Psychiatr Serv. 2001 Mar;52(3):313-22. doi: 10.1176/appi.ps.52.3.313.
- Drake RE, Bond GR, Mascayano F. Modification of the Individual Placement and Support Model of Supported Employment. Psychiatr Serv. 2023 Jun 1;74(6):656-658. doi: 10.1176/appi.ps.20220484. Epub 2023 Jan 31.
- Solomon M, Yon-Hernandez JA, Ruder S, McGurk SR, Tancredi D, Takarae Y, Stahmer AC. A randomized controlled trial protocol for evaluating the feasibility, acceptability, and work outcomes of individualized placement and support adapted for autistic adults in the community. Contemp Clin Trials Commun. 2025 Aug 19;47:101536. doi: 10.1016/j.conctc.2025.101536. eCollection 2025 Oct.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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