AutismNCT06207149
Adapting an Advocacy Services Intervention for Latinx Families of Transition-aged Youth With Autism Spectrum Disorder
A study testing ASISTIR in people with Autism, run by Vanderbilt University at 1 site in United States.
Trial summary
When youth with autism spectrum disorder (ASD) transition from school to adult services, they fall off a "service cliff." To increase access to services, the investigators developed the ASSIST program, which teaches parents how to advocate for adult services on behalf of youth with ASD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- ASISTIR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2022to 15 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Must understand Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Champaign, Illinois, 61820
About this study
When youth with autism spectrum disorder (ASD) transition from school to adult services, they fall off a "service cliff." To increase access to services, the investigators developed the ASSIST program, which teaches parents how to advocate for adult services on behalf of youth with ASD. In a pilot randomized controlled trial (RCT: R34 MH104428), treatment group (versus control) participants demonstrated significantly improved knowledge of adult services, advocacy, and empowerment. Sons/daughters of treatment group participants had increased access to services. For advocacy services interventions like ASSIST to be equitable, they need to reach families who are at greatest risk for service disparities. Latinx youth with ASD are one such underserved population. Relative to White youth, Latinx youth with ASD receive significantly fewer post-secondary education, health, and employment services and face worse post-school outcomes. In addition to the barriers which hinder service access for all families, Latinx families face unique barriers to service access (e.g., language, cultural differences, citizenship, discrimination) making them a marginalized population. In this project, the investigators are adapting the ASSIST curriculum and related measures for Latinx parents of transition-aged youth with ASD. Specifically, the investigators will leverage ASSIST data and data from Latinx, non-ASSIST parents to inform adaptations to the ASSIST curriculum. The investigators will also conduct pre-testing and a cross-cultural adaptation process to revise the ASSIST measures for Latinx families. The investigators will test the adapted ASSIST curriculum with a randomized controlled trial to determine its feasibility, acceptability and efficacy on intervention targets (knowledge, advocacy, and empowerment) and outcome of interest (service access). This project is aligned with NIMH priorities by examining services from adolescence to adulthood (PA-21-199) and by adapting a program to improve mental health services for underserved populations NIMH 2020 Strategic plan). It is also responsive to the Interagency Autism Coordinating Committee core value of "equity" in reducing disparities with respect to cultural backgrounds. Further, if successful, it will be the first intervention to directly address service disparities for Latinx families of youth with ASD who are transitioning to adulthood.
- Conditions
- Autism
- Being tested
- ASISTIR
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASISTIRBehavioural
This will be a 24 hour advocacy program focused on adult disability services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will attend an advocacy program. Receives: Behavioral: ASISTIR |
| Waitlist-Control Group | Active comparator | Participants will receive the written materials of the advocacy program. After completing the intervention group completes the advocacy program, the waitlist-control group participants will be able to participate in the advocacy program. Receives: Behavioral: ASISTIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Knowledge Scale
A multiple-choice, multi-item scale assessing knowledge about adult disability services. Higher scores indicate greater knowledge (thus, higher scores are considered better outcomes). The scale ranges from 0 (minimum) to 24 (maximum). Unabbreviated scale title is Knowledge. The construct it measures is knowledge of adult disability services.
Measured: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training).
Advocacy Activities Scale
A scale with three subscales assessing individual, peer, and systemic advocacy. Only individual advocacy was expected to increase. Higher scores indicate greater advocacy (thus, higher scores means better outcomes). The scale ranges from 12 (minimum) to 60 (maximum). Unabbreviated scale title is Advocacy. The construct the scale measures is advocacy.
Measured: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
Family Empowerment Scale-Family Subscale
The Family Empowerment Scale (the full scale name) measures the constructs of empowerment in relation to the family, community, and service delivery system.Higher scores indicate greater empowerment (thus, higher scores means a better outcome). The scale ranges from 12 (minimum) to 60 (maximum). The items are summed to create a total score. Unabbreviated scale title is Family Empowerment. The construct that the Family Subscale measures is empowerment within the family.
Measured: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
Unmet Service Scale
A scale measuring the extent of service needs among individuals with autism. Scores range from 0 (minimum)-16 (maximum) with higher scores indicating more unmet service needs (thus, lower scores are better outcomes). Unabbreviated scale title is Unmet Services. The construct is unmet service needs.
Measured: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
Family Empowerment Scale-Service Delivery System Subscale
The Family Empowerment Scale (the full scale name) measures the construct of empowerment in relation to the family, community, and service delivery system.Higher scores indicate greater empowerment (thus, higher scores means a better outcome). The scale ranges from 12 (minimum) to 55 (maximum). The items are summed to create a total score. Unabbreviated scale title is Services Empowerment. The construct this subscale measures is empowerment within the service delivery system.
Measured: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
Family Empowerment Scale-Community and Political Subscale
The Family Empowerment Scale (the full scale name) measures the constructs of empowerment in relation to the family, community, and service delivery system.Higher scores indicate greater empowerment (thus, higher scores means a better outcome). The scale ranges from 12 (minimum) to 55 (maximum). The items are summed to create a total score. Unabbreviated scale title is Community and Political Empowerment. The construct that the Community and Political Subscale measures is empowerment within the community and political contexts.
Measured: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
Advocacy Skills and Comfort
The full name of this measure is Advocacy Skills and comfort. The Advocacy Skills and comfort scale measures the construct of comfort with advocacy skills. The scale ranges from 10 to 50. Higher scores are better indicating greater comfort with advocacy skills. The items are summed to create a composite.
Measured: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start20 Aug 2022
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Burke, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207149
- Sponsor's protocol ID
- 1R03MH129757-01A1
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2023
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to upload de-identified data to NDAR.
Publications
Burke MM, Ramos-Torres S, Espinosa GH, Hincapie AL, Aleman-Tovar J, Perez R, Puente C. Testing an Advocacy Program to Improve Service Access Among Latino Families of Autistic Youth: A Randomized Controlled Trial. Autism Res. 2025 Aug;18(8):1714-1724. doi: 10.1002/aur.70068. Epub 2025 Jun 21.
PubMed 40542546
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting an Advocacy Services Intervention for Latinx Families of Transition-aged Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06207149
- Acronym / sponsor ID
- 1R03MH129757-01A1
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Posted 30 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When youth with autism spectrum disorder (ASD) transition from school to adult services, they fall off a "service cliff." To increase access to services, the investigators developed the ASSIST program, which teaches parents how to advocate for adult services on behalf of youth with ASD. In a pilot randomized controlled trial (RCT: R34 MH104428), treatment group (versus control) participants demonstrated significantly improved knowledge of adult services, advocacy, and empowerment. Sons/daughters of treatment group participants had increased access to services. For advocacy services interventions like ASSIST to be equitable, they need to reach families who are at greatest risk for service disparities. Latinx youth with ASD are one such underserved population. Relative to White youth, Latinx youth with ASD receive significantly fewer post-secondary education, health, and employment services and face worse post-school outcomes. In addition to the barriers which hinder service access for all families, Latinx families face unique barriers to service access (e.g., language, cultural differences, citizenship, discrimination) making them a marginalized population. In this project, the investigators are adapting the ASSIST curriculum and related measures for Latinx parents of transition-aged youth with ASD. Specifically, the investigators will leverage ASSIST data and data from Latinx, non-ASSIST parents to inform adaptations to the ASSIST curriculum. The investigators will also conduct pre-testing and a cross-cultural adaptation process to revise the ASSIST measures for Latinx families. The investigators will test the adapted ASSIST curriculum with a randomized controlled trial to determine its feasibility, acceptability and efficacy on intervention targets (knowledge, advocacy, and empowerment) and outcome of interest (service access). This project is aligned with NIMH priorities by examining services from adolescence to adulthood (PA-21-199) and by adapting a program to improve mental health services for underserved populations NIMH 2020 Strategic plan). It is also responsive to the Interagency Autism Coordinating Committee core value of "equity" in reducing disparities with respect to cultural backgrounds. Further, if successful, it will be the first intervention to directly address service disparities for Latinx families of youth with ASD who are transitioning to adulthood.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ASISTIRParticipants will attend an advocacy program. |
| Waitlist-Control Group | Active comparator | Behavioral: ASISTIRParticipants will receive the written materials of the advocacy program. After completing the intervention group completes the advocacy program, the waitlist-control group participants will be able to participate in the advocacy program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Must understand Spanish
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 |
|---|---|---|
| ASISTIRThis will be a 24 hour advocacy program focused on adult disability services. | Behavioural | Intervention, Waitlist-Control Group |
Primary outcome
Disability Knowledge Scale
Time frame: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training).
A multiple-choice, multi-item scale assessing knowledge about adult disability services. Higher scores indicate greater knowledge (thus, higher scores are considered better outcomes). The scale ranges from 0 (minimum) to 24 (maximum). Unabbreviated scale title is Knowledge. The construct it measures is knowledge of adult disability services.
Advocacy Activities Scale
Time frame: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
A scale with three subscales assessing individual, peer, and systemic advocacy. Only individual advocacy was expected to increase. Higher scores indicate greater advocacy (thus, higher scores means better outcomes). The scale ranges from 12 (minimum) to 60 (maximum). Unabbreviated scale title is Advocacy. The construct the scale measures is advocacy.
Family Empowerment Scale-Family Subscale
Time frame: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
The Family Empowerment Scale (the full scale name) measures the constructs of empowerment in relation to the family, community, and service delivery system.Higher scores indicate greater empowerment (thus, higher scores means a better outcome). The scale ranges from 12 (minimum) to 60 (maximum). The items are summed to create a total score. Unabbreviated scale title is Family Empowerment. The construct that the Family Subscale measures is empowerment within the family.
Unmet Service Scale
Time frame: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
A scale measuring the extent of service needs among individuals with autism. Scores range from 0 (minimum)-16 (maximum) with higher scores indicating more unmet service needs (thus, lower scores are better outcomes). Unabbreviated scale title is Unmet Services. The construct is unmet service needs.
Family Empowerment Scale-Service Delivery System Subscale
Time frame: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
The Family Empowerment Scale (the full scale name) measures the construct of empowerment in relation to the family, community, and service delivery system.Higher scores indicate greater empowerment (thus, higher scores means a better outcome). The scale ranges from 12 (minimum) to 55 (maximum). The items are summed to create a total score. Unabbreviated scale title is Services Empowerment. The construct this subscale measures is empowerment within the service delivery system.
Family Empowerment Scale-Community and Political Subscale
Time frame: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
The Family Empowerment Scale (the full scale name) measures the constructs of empowerment in relation to the family, community, and service delivery system.Higher scores indicate greater empowerment (thus, higher scores means a better outcome). The scale ranges from 12 (minimum) to 55 (maximum). The items are summed to create a total score. Unabbreviated scale title is Community and Political Empowerment. The construct that the Community and Political Subscale measures is empowerment within the community and political contexts.
Advocacy Skills and Comfort
Time frame: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training)
The full name of this measure is Advocacy Skills and comfort. The Advocacy Skills and comfort scale measures the construct of comfort with advocacy skills. The scale ranges from 10 to 50. Higher scores are better indicating greater comfort with advocacy skills. The items are summed to create a composite.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40542546Burke MM, Ramos-Torres S, Espinosa GH, Hincapie AL, Aleman-Tovar J, Perez R, Puente C. Testing an Advocacy Program to Improve Service Access Among Latino Families of Autistic Youth: A Randomized Controlled Trial. Autism Res. 2025 Aug;18(8):1714-1724. doi: 10.1002/aur.70068. Epub 2025 Jun 21.
- Individual participant dataSharing planned: Yes. We plan to upload de-identified data to NDAR.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASISTIR in people with Autism, run by Vanderbilt 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 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: finished, as of the sponsor's last update on 1 Jul 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?
Yes. Results are posted in the registry (first posted 30 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disability Knowledge Scale (time frame: Pre, Post (three months after the Intervention group takes the training), and Follow-up (six months after the intervention group takes the training).). The study lists 7 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 NCT06207149, which also lists 1 linked publication.
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 1 Jul 2026.