AutismMENUNCT07319234
Development of MENU Protocol
A study testing MENU and Online modules in people with Autism and Mental Health, run by University of Texas at Austin.
Trial summary
The overarching goal of this project is to reduce autism-related health disparities. The investigators will develop and pilot MENU, a culturally responsive and caregiver-driven intervention specifically designed to support underserved families of young autistic children during the diagnostic wait period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism, Mental Health
- What is being tested?
- MENU and Online modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregivers of young children between the ages of 2 and 5 years who were referred for autism diagnostic evaluation but have not yet been received services
- Caregivers from underserved populations, including families from racial and ethnic minority backgrounds (e.g., Latino and Black communities), rural communities, immigrant families, and Medicaid-eligible families in Texas
- Caregivers aged 18 years or older
Who cannot join
- Caregivers of children who have no concerns related to autism spectrum disorder
- Caregivers who are unable to provide informed consent
About this study
Official title: MENU: A Novel Family-Driven Approach to Support Families Awaiting Autism Diagnostic Evaluation
The overarching goal of this project is to reduce autism-related health disparities. The investigators will develop and pilot MENU, a culturally responsive and caregiver-driven intervention specifically designed to support underserved families of young autistic children during the diagnostic wait period. MENU will equip underserved caregivers with flexible, evidence-based strategies to improve parent mental health, child social communication, and challenging behaviors. The intervention consists of modular content drawn from three well-established practices targeting core characteristics of autism: Acceptance and Commitment Therapy for caregiver mental health and well-being, Enhanced Milieu Teaching for child social communication, and RUBI Parent Training for managing a child's challenging behaviors.
In this model, caregivers collaborate with the research team to select and sequence modules based on individual needs, preferences, and priorities, making MENU highly personalized, family-centered, and accessible. Families will engage with MENU modules over approximately 12 weeks, with duration varying based on individual goals and pacing. The project utilizes a explanatory, sequential mixed methods design, an approach that examines preliminary effectiveness and gathers detailed information on contextual factors relevant to future scale-up and sustainability within public systems of care in Texas, including Part C Early Intervention programs. Up to 50 underserved families representing diverse racial, ethnic, and linguistic backgrounds will be recruited in strategic partnership with trusted community organizations throughout Texas. To maximize accessibility and reduce barriers associated with the digital divide, the project will provide iPads and cellular data plans to families lacking adequate Internet access or devices. Following comprehensive baseline assessments, including standardized measures and clinical interviews, caregivers will collaborate with the research team to select and tailor MENU modules aligned with individual goals and needs across the three evidence-based practices. Quantitative data will be collected at baseline, immediately post-intervention, and at 3-month follow-up using validated measures of parent mental health, child social communication, and challenging behaviors. Implementation outcomes (e.g., acceptability, feasibility, usability) will be assessed in partnership with community advisors, with regular reviews informing iterative refinements to maintain cultural and contextual relevance for Texas families. By pioneering scalable supports delivered before a formal autism diagnosis, MENU challenges conventional service timelines and introduces a new model of early autism care in Texas. The project will also generate actionable data to inform policy shifts, reimbursement pathways, and integration into early childhood systems, contributing to reductions in health and educational disparities among autistic children and their families.
Read the detailed description
This project addresses health disparities by offering proactive support during a critical period when services are typically unavailable to minoritized families due to systemic delays, insurance restrictions, and limited access to care. Early autism intervention is considered a gold standard for promoting optimal child and family outcomes, yet many families remain underserved due to a lack of diagnosis. MENU aims to mitigate this disparity by providing preemptive intervention prior to formal diagnosis to improve caregiver mental health, reduce developmental delays, and enhance families' capacity to advocate for their children. The broader impact of this approach includes reducing downstream educational and health disparities, informing public insurance policy, and establishing a scalable framework for equitable early autism intervention. By introducing high-quality, scalable supports delivered before a formal diagnosis, MENU challenges conventional service timelines and establishes a new model of early autism care in Texas and other states. Key implementation challenges include recruitment and retention of underserved families and maintaining cultural and contextual relevance while providing timely support. These challenges will be mitigated through partnerships with trusted community-based organizations composed of caregivers, service providers, and autistic self-advocates.
To support successful implementation, the project includes collaborations with grassroots organizations serving caregivers of autistic children (e.g., Texas Parent to Parent, Autism Society of Texas), racially or economically minoritized families (e.g., VELA, La Puerta Waco, Compassion Waco). Project success will be measured through quantitative and qualitative data aligned with the Project Work Plan. Outcome metrics include reductions in caregiver stress (Parenting Stress Index-Short Form), improvements in child communication (Vineland Adaptive Behavior Scales or Social Communication Questionnaire), improvements in challenging behaviors (Behavior Assessment System for Children), module completion rates, caregiver satisfaction, and implementation outcomes such as feasibility (Feasibility of Intervention Measure), acceptability (Acceptability of Intervention Measure), and usability (Intervention Usability Scale). Data will be collected at baseline, post-intervention, and follow-up, along with semi-structured interviews to assess sustained impact. The intervention period will last approximately 16 weeks, allowing sufficient time for meaningful engagement, skill acquisition, and observable outcomes. The project team includes interdisciplinary faculty members from the University of Texas at Austin and Baylor University with extensive experience supporting underserved families of young autistic children and strong research-practice partnerships. Community partners, including Texas Early Childhood Intervention agencies and minority-serving advocacy organizations, will contribute to participant recruitment, intervention refinement, validation, and statewide dissemination.
- Conditions
- Autism, Mental Health
- Being tested
- MENU, Online modules
- Keywords
- autism, mental health, diagnostic evaluation waitlist
- Medical subject headings
- Autistic Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MENUBehavioural
The intervention consists of modular content drawn from three well-established practices targeting core characteristics of autism: Acceptance and Commitment Therapy for caregiver mental health and well-being, Enhanced Milieu Teaching for child social communication, and RUBI behavioral parent training for managing challenging behaviors. In this model, caregivers work with the research team to select and sequence modules based on their needs, preferences, and priorities, making MENU highly personalized, family-centered, and accessible. Families will engage with MENU modules over 16 weeks, although exact duration may vary based on individual family goals and pacing.
Online modulesBehavioural
Active control will receive 8 weekly online modules of their choosing
| Study group | Role | What they receive |
|---|---|---|
| MENU group | Experimental | The group receive modular content drawn from three well-established practices targeting core characteristics of autism: Acceptance and Commitment Therapy for caregiver mental health and well-being, Enhanced Milieu Teaching for child social communication, and RUBI behavioral parent training for managing challenging behaviors. Receives: Behavioral: MENU |
| Active control | Active comparator | Receiving access to online modules only Receives: Behavioral: Online modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptive Behavior Assessment System - Third Edition
Children's adaptive communication skills as measured by the Adaptive Behavior Assessment System, Third Edition (ABAS-3) Communication Domain. The Communication Domain consists of 26 items assessing receptive, expressive, and pragmatic communication skills in everyday contexts. Domain scaled scores range from 1 to 19, with higher scores indicating better adaptive communication functioning.
Measured: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)
Patient Health Questionnaire - 8
Caregiver depressive symptom severity as measured by the Patient Health Questionnaire-8 (PHQ-8), an 8-item self-report measure assessing the frequency of depressive symptoms over the past two weeks. Total scores range from 0 to 24, with higher scores indicating greater depressive symptom severity.
Measured: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)
General Anxiety Disorder - 7
Caregiver anxiety symptom severity as measured by the Generalized Anxiety Disorder 7-Item Scale (GAD-7), a 7-item self-report measure assessing the frequency of anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Measured: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)
Home Situations Questionnaire - Autism Spectrum Disorder
Child disruptive behavior in everyday home situations as measured by the Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD). The HSQ-ASD is a caregiver-reported measure consisting of items assessing the severity of noncompliant and disruptive behaviors across common home situations. Total scores range from 0 to 9, with higher scores indicating greater severity of disruptive behavior.
Measured: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)
caregiver satisfaction
a research-developed questionnaire to measure the caregiver's satisfaction of the intervention. It will be a 5 point Likert scale.
Measured: immediately post-intervention (Week 12)
Feasibility of Intervention Measure
caregivers' rating of the feasibility of the implementation on a 5-point Likert scale
Measured: immediately post-intervention (Week 12)
Acceptability of Intervention Measure
caregivers' acceptability of the intervention
Measured: immediately post-intervention (Week 12)
Intervention Usability Scale
caregivers' rating of the usability of the intervention
Measured: immediately post-intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor University
- Responsible party
- Principal investigator, James D Lee, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319234
- Sponsor's protocol ID
- MENU study
- Acronym
- MENU
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2025
- Last updated
- 15 Apr 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 because of concerns regarding participant privacy, limited resources for data sharing infrastructure
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MENU: A Novel Family-Driven Approach to Support Families Awaiting Autism Diagnostic Evaluation
- ClinicalTrials.gov ID
- NCT07319234
- Acronym / sponsor ID
- MENU / MENU study
- Conditions
- Autism, Mental Health
- Keywords
- autism, mental health, diagnostic evaluation waitlist
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Baylor University
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 6 Jan 2026 (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 overarching goal of this project is to reduce autism-related health disparities. The investigators will develop and pilot MENU, a culturally responsive and caregiver-driven intervention specifically designed to support underserved families of young autistic children during the diagnostic wait period. MENU will equip underserved caregivers with flexible, evidence-based strategies to improve parent mental health, child social communication, and challenging behaviors. The intervention consists of modular content drawn from three well-established practices targeting core characteristics of autism: Acceptance and Commitment Therapy for caregiver mental health and well-being, Enhanced Milieu Teaching for child social communication, and RUBI Parent Training for managing a child's challenging behaviors.
In this model, caregivers collaborate with the research team to select and sequence modules based on individual needs, preferences, and priorities, making MENU highly personalized, family-centered, and accessible. Families will engage with MENU modules over approximately 12 weeks, with duration varying based on individual goals and pacing. The project utilizes a explanatory, sequential mixed methods design, an approach that examines preliminary effectiveness and gathers detailed information on contextual factors relevant to future scale-up and sustainability within public systems of care in Texas, including Part C Early Intervention programs. Up to 50 underserved families representing diverse racial, ethnic, and linguistic backgrounds will be recruited in strategic partnership with trusted community organizations throughout Texas. To maximize accessibility and reduce barriers associated with the digital divide, the project will provide iPads and cellular data plans to families lacking adequate Internet access or devices. Following comprehensive baseline assessments, including standardized measures and clinical interviews, caregivers will collaborate with the research team to select and tailor MENU modules aligned with individual goals and needs across the three evidence-based practices. Quantitative data will be collected at baseline, immediately post-intervention, and at 3-month follow-up using validated measures of parent mental health, child social communication, and challenging behaviors. Implementation outcomes (e.g., acceptability, feasibility, usability) will be assessed in partnership with community advisors, with regular reviews informing iterative refinements to maintain cultural and contextual relevance for Texas families. By pioneering scalable supports delivered before a formal autism diagnosis, MENU challenges conventional service timelines and introduces a new model of early autism care in Texas. The project will also generate actionable data to inform policy shifts, reimbursement pathways, and integration into early childhood systems, contributing to reductions in health and educational disparities among autistic children and their families.
Detailed description
This project addresses health disparities by offering proactive support during a critical period when services are typically unavailable to minoritized families due to systemic delays, insurance restrictions, and limited access to care. Early autism intervention is considered a gold standard for promoting optimal child and family outcomes, yet many families remain underserved due to a lack of diagnosis. MENU aims to mitigate this disparity by providing preemptive intervention prior to formal diagnosis to improve caregiver mental health, reduce developmental delays, and enhance families' capacity to advocate for their children. The broader impact of this approach includes reducing downstream educational and health disparities, informing public insurance policy, and establishing a scalable framework for equitable early autism intervention. By introducing high-quality, scalable supports delivered before a formal diagnosis, MENU challenges conventional service timelines and establishes a new model of early autism care in Texas and other states. Key implementation challenges include recruitment and retention of underserved families and maintaining cultural and contextual relevance while providing timely support. These challenges will be mitigated through partnerships with trusted community-based organizations composed of caregivers, service providers, and autistic self-advocates.
To support successful implementation, the project includes collaborations with grassroots organizations serving caregivers of autistic children (e.g., Texas Parent to Parent, Autism Society of Texas), racially or economically minoritized families (e.g., VELA, La Puerta Waco, Compassion Waco). Project success will be measured through quantitative and qualitative data aligned with the Project Work Plan. Outcome metrics include reductions in caregiver stress (Parenting Stress Index-Short Form), improvements in child communication (Vineland Adaptive Behavior Scales or Social Communication Questionnaire), improvements in challenging behaviors (Behavior Assessment System for Children), module completion rates, caregiver satisfaction, and implementation outcomes such as feasibility (Feasibility of Intervention Measure), acceptability (Acceptability of Intervention Measure), and usability (Intervention Usability Scale). Data will be collected at baseline, post-intervention, and follow-up, along with semi-structured interviews to assess sustained impact. The intervention period will last approximately 16 weeks, allowing sufficient time for meaningful engagement, skill acquisition, and observable outcomes. The project team includes interdisciplinary faculty members from the University of Texas at Austin and Baylor University with extensive experience supporting underserved families of young autistic children and strong research-practice partnerships. Community partners, including Texas Early Childhood Intervention agencies and minority-serving advocacy organizations, will contribute to participant recruitment, intervention refinement, validation, and statewide dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MENU group | Experimental | Behavioral: MENUThe group receive modular content drawn from three well-established practices targeting core characteristics of autism: Acceptance and Commitment Therapy for caregiver mental health and well-being, Enhanced Milieu Teaching for child social communication, and RUBI behavioral parent training for managing challenging behaviors. |
| Active control | Active comparator | Behavioral: Online modulesReceiving access to online modules only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caregivers of young children between the ages of 2 and 5 years who were referred for autism diagnostic evaluation but have not yet been received services
- Caregivers from underserved populations, including families from racial and ethnic minority backgrounds (e.g., Latino and Black communities), rural communities, immigrant families, and Medicaid-eligible families in Texas
- Caregivers aged 18 years or older
Key exclusion criteria (2 listed)
- Caregivers of children who have no concerns related to autism spectrum disorder
- Caregivers who are unable to provide informed consent
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 |
|---|---|---|
| MENUThe intervention consists of modular content drawn from three well-established practices targeting core characteristics of autism: Acceptance and Commitment Therapy for caregiver mental health and well-being, Enhanced Milieu Teaching for child social communication, and RUBI behavioral parent training for managing challenging behaviors. In this model, caregivers work with the research team to select and sequence modules based on their needs, preferences, and priorities, making MENU highly personalized, family-centered, and accessible. Families will engage with MENU modules over 16 weeks, although exact duration may vary based on individual family goals and pacing. | Behavioural | MENU group |
| Online modulesActive control will receive 8 weekly online modules of their choosing | Behavioural | Active control |
Primary outcome
Adaptive Behavior Assessment System - Third Edition
Time frame: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)
Children's adaptive communication skills as measured by the Adaptive Behavior Assessment System, Third Edition (ABAS-3) Communication Domain. The Communication Domain consists of 26 items assessing receptive, expressive, and pragmatic communication skills in everyday contexts. Domain scaled scores range from 1 to 19, with higher scores indicating better adaptive communication functioning.
Patient Health Questionnaire - 8
Time frame: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)
Caregiver depressive symptom severity as measured by the Patient Health Questionnaire-8 (PHQ-8), an 8-item self-report measure assessing the frequency of depressive symptoms over the past two weeks. Total scores range from 0 to 24, with higher scores indicating greater depressive symptom severity.
General Anxiety Disorder - 7
Time frame: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)
Caregiver anxiety symptom severity as measured by the Generalized Anxiety Disorder 7-Item Scale (GAD-7), a 7-item self-report measure assessing the frequency of anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Home Situations Questionnaire - Autism Spectrum Disorder
Time frame: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)
Child disruptive behavior in everyday home situations as measured by the Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD). The HSQ-ASD is a caregiver-reported measure consisting of items assessing the severity of noncompliant and disruptive behaviors across common home situations. Total scores range from 0 to 9, with higher scores indicating greater severity of disruptive behavior.
caregiver satisfaction
Time frame: immediately post-intervention (Week 12)
a research-developed questionnaire to measure the caregiver's satisfaction of the intervention. It will be a 5 point Likert scale.
Feasibility of Intervention Measure
Time frame: immediately post-intervention (Week 12)
caregivers' rating of the feasibility of the implementation on a 5-point Likert scale
Acceptability of Intervention Measure
Time frame: immediately post-intervention (Week 12)
caregivers' acceptability of the intervention
Intervention Usability Scale
Time frame: immediately post-intervention (Week 12)
caregivers' rating of the usability of the intervention
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 15 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because of concerns regarding participant privacy, limited resources for data sharing infrastructure
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MENU and Online modules in people with Autism and Mental Health, run by University of Texas at Austin.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Adaptive Behavior Assessment System - Third Edition (time frame: Baseline (Day 1), immediately post-intervention (Week 12), and 1-month post-intervention follow-up (Week 16)). 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?
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 15 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.