Clinical trial NCT06829264: Testing an Evidence-Based Supported Employment Model in Autistic Young Adults
Official title: A Pilot Trial of the Individualized Placement and Support Model in Autistic Adults in the Community
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Intellectual Disability
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to enhance employment outcomes for young adults with autism and intellectual and developmental disabilities (IDD) through the implementation of an evidence-based supported employment model known as Individual Placement and Support for Autism (IPS-AUT). The study will evaluate the feasibility, acceptability, and effectiveness of IPS-AUT in promoting Competitive Integrated Employment (CIE). The trial will involve partnerships with supported employment agencies, training providers in IPS-AUT, and assessing employment outcomes and implementation factors. The ultimate goal is to create a scalable, evidence-based employment support model for individuals with autism.

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.

Eligibility criteria: 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 21-40 years.
* Minimum 4th-grade reading level (approximately mild ID).
* Not currently employed but seeking employment.

Exclusion Criteria:

- Not interested in employment.

Primary outcomes:
measure: Feasibility of IPS Implementation
timeFrame: 18 months
measure: Competitive Integrated Employment (CIE) Outcomes
timeFrame: 18 months
measure: Acceptability of IPS Implementation
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis MIND Institute
state: California
Study officials:
affiliation: University of California, Davis
name: Marjorie Solomon, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.