NCT06829264

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

January 24, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 24, 2025

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Feasibility of IPS Implementation

    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

  • Competitive Integrated Employment (CIE) Attainment

    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

    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

  • Acceptability of IPS Implementation

    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

  • Parent/Carer Engagement

    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

    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

Study Arms (2)

Treatment Group - Agencies Receiving IPS

EXPERIMENTAL

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.

Behavioral: Individualized Placement and Support Model

Control Group - Agencies Receiving Supportive Employment Intervention

ACTIVE COMPARATOR

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.

Behavioral: Supportive Employment Intervention

Interventions

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.

Treatment Group - Agencies Receiving IPS

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.

Control Group - Agencies Receiving Supportive Employment Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Not interested in employment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Davis MIND Institute

Sacramento, California, 95817, United States

RECRUITING

University of California, Davis MIND Institute

Sacramento, California, 95817, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27269028BACKGROUND
  • 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.

    PMID: 11239097BACKGROUND
  • 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.

    PMID: 22295007BACKGROUND
  • 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.

    PMID: 36718603BACKGROUND
  • 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.

MeSH Terms

Conditions

Autism Spectrum DisorderIntellectual Disability

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marjorie Solomon, PhD, MBA

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo A. Yon Hernandez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 17, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared with other researchers. All collected data will be used solely for this study and will remain confidential in accordance with the IRB protocol.

Locations