Autism Spectrum DisorderNCT05099705
Testing a Family Service Navigator Program for Low-resourced Families of Young Children With Autism Spectrum Disorder
A study testing Access to a Family Service Navigator and Treatment Support System in people with Autism Spectrum Disorder and Mental Health Services, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for low-resourced families of young children (aged 3-5) with autism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Mental Health Services
- What is being tested?
- Access to a Family Service Navigator and Treatment Support System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a parent who is in some way from a low-resourced community,
- Be the parent a child with autism between the ages of 3-5,
- Be age 18 or older,
- Want assistance with navigating service delivery systems,
- Be English speaking or Spanish-speaking,
- Be able to provide informed consent,
Show all 13Show fewer
- Own a phone which can use the treatment support system (or be provided a phone from the Public Assistance Office or from the grant)
- Agree to participate in the navigator training and become an navigator,
- Be a parent who is in some way from a low-resourced community,
- Be the parent a child with autism who is older than 5,
- Be age 18 or older, Be English speaking,
- Be able to provide informed consent,
- Own a phone which can use the treatment support system (or be provided a phone from the Public Assistance Office or from the grant)
Who cannot join
- -Individuals who do not meet all inclusion criteria are by definition excluded.
- For the navigators in the clinical trial, they must meet inclusion and exclusion criteria:
- -Individuals who do not meet all inclusion criteria are by definition excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for low-resourced families of young children (aged 3-5) with autism. The hypothesis is that the navigator training and treatment support system will help enable navigators to support families of young children with autism in accessing needed services.
Read the detailed description
The purpose of this project is to determine whether access to a family service navigator/treatment support system improves outcomes among families of young children (aged 3-5) from low-resourced communities. Pilot work includes interviews and pre/post surveys. Then, a randomized controlled trial will be conducted by randomly assigning families to navigators/treatment support systems or the non-personalized comparison condition (information, training, and referral services). Three-month, six-month, and nine-month follow-up survey data will be collected. Each of the 20 navigators will support two families. Intervention families will have access to the navigator and the treatment support system, which includes a dashboard showing their child's service needs, resources, and a platform to facilitate and document communication between navigators and families. The treatment support system will also allow the navigator supervisor to ensure fidelity of the navigators' support to the family. The statistician will randomize 55 families who meet the inclusionary criteria to each condition--40 individuals will receive navigator/treatment support system (intervention group) and 15 individuals will receive information, training, and referrals (comparison group).
- Conditions
- Autism Spectrum Disorder, Mental Health Services
- Being tested
- Access to a Family Service Navigator and Treatment Support System
- Keywords
- Autism, Navigator, Services, Children, Low-resource
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to a Family Service Navigator and Treatment Support SystemBehavioural
An RCT will be conducted. 40 participants will be randomly assigned to the intervention group and 15 participants to the non-personalized comparison group (i.e., information, training, and referral). The intervention group will have access to a navigator and the treatment support system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Access to an FSN/TSS) | Experimental | 40 participants will be randomly assigned to the intervention group (i.e., to receive an FSN and have access to the TSS). The FSN may meet with the participant at least twice and provide navigation support. Receives: Behavioral: Access to a Family Service Navigator and Treatment Support System |
| Control Group (Access to Information, training and referral) | No intervention | 15 participants will be randomly assigned to the non-personalized comparison group (i.e., information, training, and referral). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge at 9 months
Called the Autism Knowledge Scale, a multi-item measure examining knowledge of autism services. There are 24 items with higher scores indicating more knowledge. Scale ranges from 0-24.
Measured: At the pre-survey and at the nine-month survey
Change in Skills at 9 months
Called the Comfort with Advocacy Scale, A multi-item measure examining skills to identify, access, and receive services. There are 12 items with higher scores indicating greater advocacy. Scale ranges from 0 to 60.
Measured: At the pre-survey and at the nine-month survey
Change in Advocacy at 9 months
Called the Advocacy Skills Scale, a multi-item measure examining the frequency of advocacy activities. There are nine items with higher scores indicating greater advocacy. Scale ranges from 9 to 45.
Measured: At the pre-survey and at the nine-month survey
Change in Empowerment at 9 months
Called the Family Empowerment Scale, aa multi-item measure examining empowerment in family, services, and community/political environments. There are 34 items with higher scores indicating greater empowerment. Scale ranges from 0 to 136.
Measured: At the pre-survey and at the nine-month survey
Change in Parenting self-efficacy at 9 months
Called the Self-Efficacy scale, a multi-item measure examining competence in parenting. There are nine items with higher scores indicating greater self-efficacy. Scale ranges from 0 to 36.
Measured: At the pre-survey and at the nine-month survey
Change in Service Delivery Outcomes
Called the adapted service measure scale, access to the type, number, and quality of services and unmet service needs. There are over 20 services with higher scores indicating needing greater services. Scale ranges from 0 to 20.
Measured: At the pre-survey and at the three-month, six-month, and nine-month survey
Change in Adaptive and maladaptive behavior at 9 months
Called the Vineland Adaptive Behavior Scale, a multi-item measure examining adaptive and maladaptive behavior. There are 100 items with higher scores indicating greater adaptive behavior. Scale ranges from 0 to 100.
Measured: At the pre-survey and at the nine-month survey
Change in Social responsiveness at 9 months
Called the Social Responsiveness Scale, a multi-item measure to examine social responsiveness. There are sixty items with higher scores indicating greater social responsiveness. Scale ranges from 0 to 180.
Measured: At the pre-survey and at the nine-month survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Jul 2022
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Model description
- Later in the project, a randomized controlled trial will be conducted. 40 participants will be in the intervention group and 15 participants will be in the non-personalized comparison group (i.e., information, training, and referral). Families will complete pre/post measures related to: intervention targets (except the ability to facilitate knowledge), service delivery outcomes, adaptive and maladaptive behavior, and autism symptoms. Information will also be collected via the treatment support system; such information will include the type and frequency of communication between the navigator and the family. Individual interviews will be collected with the navigator supervisor and the 20 navigators to identify barriers to the navigator model for low-resourced families.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Burke, Vanderbilt University
- Investigators
- Meghan Burke, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099705
- Sponsor's protocol ID
- Vanderbilt University
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2021
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of data generated by this project will be an important part of the proposed activities of this research and will be carried out in several ways. All research resources developed in this project will be made readily available to the scientific community for non-profit research purposes. The main mechanism for the transfer of information will take the form of peer-reviewed publications and presentations/posters at scientific conferences. Information is collected from participants upon enrollment will be generated to a Global Unique Identifier. Annual reports with de-identified information will be presented to National Institute of Mental Health annually and more often upon request. By the completion of the project, all data will be de-identified and relevant documentation to facilitate data sharing will be available.
Publications
Magana, S., et al., Use of promotoras de salud in interventions with Latino families of children with IDD. International Review of Research in Developmental Disabilities, 2014. 47: p. 39-75
Burke, M.M. and S.E. Goldman, Special education advocacy among culturally and linguistically diverse families Journal of Research in Special Educational Needs 2018. 1: p. 3-14.
Maas, C.J. and J.P. Hox, Sufficient sample sizes for multilevel modeling. Methodology, 2005. 1: p. 86- 92.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Family Service Navigator Program for Low-resourced Families of Young Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05099705
- Acronym / sponsor ID
- Vanderbilt University
- Conditions
- Autism Spectrum Disorder, Mental Health Services
- Keywords
- Autism, Navigator, Services, Children, Low-resource
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 29 Oct 2021 (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.
The purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for low-resourced families of young children (aged 3-5) with autism. The hypothesis is that the navigator training and treatment support system will help enable navigators to support families of young children with autism in accessing needed services.
Detailed description
The purpose of this project is to determine whether access to a family service navigator/treatment support system improves outcomes among families of young children (aged 3-5) from low-resourced communities. Pilot work includes interviews and pre/post surveys. Then, a randomized controlled trial will be conducted by randomly assigning families to navigators/treatment support systems or the non-personalized comparison condition (information, training, and referral services). Three-month, six-month, and nine-month follow-up survey data will be collected. Each of the 20 navigators will support two families. Intervention families will have access to the navigator and the treatment support system, which includes a dashboard showing their child's service needs, resources, and a platform to facilitate and document communication between navigators and families. The treatment support system will also allow the navigator supervisor to ensure fidelity of the navigators' support to the family. The statistician will randomize 55 families who meet the inclusionary criteria to each condition--40 individuals will receive navigator/treatment support system (intervention group) and 15 individuals will receive information, training, and referrals (comparison group).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Later in the project, a randomized controlled trial will be conducted. 40 participants will be in the intervention group and 15 participants will be in the non-personalized comparison group (i.e., information, training, and referral). Families will complete pre/post measures related to: intervention targets (except the ability to facilitate knowledge), service delivery outcomes, adaptive and maladaptive behavior, and autism symptoms. Information will also be collected via the treatment support system; such information will include the type and frequency of communication between the navigator and the family. Individual interviews will be collected with the navigator supervisor and the 20 navigators to identify barriers to the navigator model for low-resourced families.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Access to an FSN/TSS) | Experimental | Behavioral: Access to a Family Service Navigator and Treatment Support System40 participants will be randomly assigned to the intervention group (i.e., to receive an FSN and have access to the TSS). The FSN may meet with the participant at least twice and provide navigation support. |
| Control Group (Access to Information, training and referral) | No intervention | –15 participants will be randomly assigned to the non-personalized comparison group (i.e., information, training, and referral). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be a parent who is in some way from a low-resourced community,
- Be the parent a child with autism between the ages of 3-5,
- Be age 18 or older,
- Want assistance with navigating service delivery systems,
- Be English speaking or Spanish-speaking,
Key exclusion criteria (3 listed)
- -Individuals who do not meet all inclusion criteria are by definition excluded.
- For the navigators in the clinical trial, they must meet inclusion and exclusion criteria:
- -Individuals who do not meet all inclusion criteria are by definition excluded.
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 |
|---|---|---|
| Access to a Family Service Navigator and Treatment Support SystemAn RCT will be conducted. 40 participants will be randomly assigned to the intervention group and 15 participants to the non-personalized comparison group (i.e., information, training, and referral). The intervention group will have access to a navigator and the treatment support system. | Behavioural | Intervention Group (Access to an FSN/TSS) |
Primary outcome
Change in Knowledge at 9 months
Time frame: At the pre-survey and at the nine-month survey
Called the Autism Knowledge Scale, a multi-item measure examining knowledge of autism services. There are 24 items with higher scores indicating more knowledge. Scale ranges from 0-24.
Change in Skills at 9 months
Time frame: At the pre-survey and at the nine-month survey
Called the Comfort with Advocacy Scale, A multi-item measure examining skills to identify, access, and receive services. There are 12 items with higher scores indicating greater advocacy. Scale ranges from 0 to 60.
Change in Advocacy at 9 months
Time frame: At the pre-survey and at the nine-month survey
Called the Advocacy Skills Scale, a multi-item measure examining the frequency of advocacy activities. There are nine items with higher scores indicating greater advocacy. Scale ranges from 9 to 45.
Change in Empowerment at 9 months
Time frame: At the pre-survey and at the nine-month survey
Called the Family Empowerment Scale, aa multi-item measure examining empowerment in family, services, and community/political environments. There are 34 items with higher scores indicating greater empowerment. Scale ranges from 0 to 136.
Change in Parenting self-efficacy at 9 months
Time frame: At the pre-survey and at the nine-month survey
Called the Self-Efficacy scale, a multi-item measure examining competence in parenting. There are nine items with higher scores indicating greater self-efficacy. Scale ranges from 0 to 36.
Change in Service Delivery Outcomes
Time frame: At the pre-survey and at the three-month, six-month, and nine-month survey
Called the adapted service measure scale, access to the type, number, and quality of services and unmet service needs. There are over 20 services with higher scores indicating needing greater services. Scale ranges from 0 to 20.
Change in Adaptive and maladaptive behavior at 9 months
Time frame: At the pre-survey and at the nine-month survey
Called the Vineland Adaptive Behavior Scale, a multi-item measure examining adaptive and maladaptive behavior. There are 100 items with higher scores indicating greater adaptive behavior. Scale ranges from 0 to 100.
Change in Social responsiveness at 9 months
Time frame: At the pre-survey and at the nine-month survey
Called the Social Responsiveness Scale, a multi-item measure to examine social responsiveness. There are sixty items with higher scores indicating greater social responsiveness. Scale ranges from 0 to 180.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- BackgroundMagana, S., et al., Use of promotoras de salud in interventions with Latino families of children with IDD. International Review of Research in Developmental Disabilities, 2014. 47: p. 39-75
- BackgroundBurke, M.M. and S.E. Goldman, Special education advocacy among culturally and linguistically diverse families Journal of Research in Special Educational Needs 2018. 1: p. 3-14.
- BackgroundMaas, C.J. and J.P. Hox, Sufficient sample sizes for multilevel modeling. Methodology, 2005. 1: p. 86- 92.
- Individual participant dataSharing planned: Yes. Sharing of data generated by this project will be an important part of the proposed activities of this research and will be carried out in several ways. All research resources developed in this project will be made readily available to the scientific community for non-profit research purposes. The main mechanism for the transfer of information will take the form of peer-reviewed publications and presentations/posters at scientific conferences. Information is collected from participants upon enrollment will be generated to a Global Unique Identifier. Annual reports with de-identified information will be presented to National Institute of Mental Health annually and more often upon request. By the completion of the project, all data will be de-identified and relevant documentation to facilitate data sharing will be available.
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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.
Meghan Burke, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to a Family Service Navigator and Treatment Support System in people with Autism Spectrum Disorder and Mental Health Services, 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 13 inclusion and 3 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 9 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Knowledge at 9 months (time frame: At the pre-survey and at the nine-month survey). The study lists 8 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 NCT05099705, which also lists 3 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 9 Jun 2026.