Autism Spectrum DisorderNCT06829264
Testing an Evidence-Based Supported Employment Model in Autistic Young Adults
A study testing Individualized Placement and Support Model and Supportive Employment Intervention in people with Autism Spectrum Disorder and Intellectual Disability, run by University of California, Davis at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autism Spectrum Disorder, Intellectual Disability
- What is being tested?
- Individualized Placement and Support Model and Supportive Employment Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Not interested in employment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis MIND Institute
Sacramento, California, 95817
About this study
Official title: A Pilot Trial of the Individualized Placement and Support Model in Autistic Adults in the Community
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Intellectual Disability
- Being tested
- Individualized Placement and Support Model, Supportive Employment Intervention
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Placement and Support ModelBehavioural
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.
Supportive Employment InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Supportive Employment Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjorie Solomon, PhD, MBA, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829264
- Sponsor's protocol ID
- 2024578
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 27269028Bond 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.
PubMed 11239097Bond 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.
PubMed 22295007Drake 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.
PubMed 36718603Solomon 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.
PubMed 40893727
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of the Individualized Placement and Support Model in Autistic Adults in the Community
- ClinicalTrials.gov ID
- NCT06829264
- Acronym / sponsor ID
- 2024578
- Conditions
- Autism Spectrum Disorder, Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group - Agencies Receiving IPS | Experimental | Behavioral: Individualized Placement and Support ModelParticipating 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. |
| Control Group - Agencies Receiving Supportive Employment Intervention | Active comparator | Behavioral: Supportive Employment InterventionOne 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Not interested in employment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Placement and Support ModelThe 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. | Behavioural | Treatment Group - Agencies Receiving IPS |
| Supportive Employment InterventionThis 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. | Behavioural | Control Group - Agencies Receiving Supportive Employment Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 27269028Drake 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.
- Background: PubMed 11239097Bond 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.
- Background: PubMed 22295007Bond 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.
- Background: PubMed 36718603Drake 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.
- Derived from this study: PubMed 40893727Solomon 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjorie Solomon, PhD, MBA principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Placement and Support Model and Supportive Employment Intervention in people with Autism Spectrum Disorder and Intellectual Disability, run by University of California, Davis 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 0 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of IPS Implementation (time frame: 18 months). 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?
On the ClinicalTrials.gov record for NCT06829264, which also lists 5 linked publications.
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 17 Aug 2026; AzTrials last refreshed its copy on 3 Nov 2026.