Development of MENU Protocol

NCT07319234 | Not Yet Recruiting

• 1 other identifier: MENU study
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Autism; Mental Health

Keywords

autism; mental health; diagnostic evaluation waitlist

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  immediately post-intervention (Week 12)

• Feasibility of Intervention Measure

  caregivers' rating of the feasibility of the implementation on a 5-point Likert scale

  immediately post-intervention (Week 12)

• Acceptability of Intervention Measure

  caregivers' acceptability of the intervention

  immediately post-intervention (Week 12)

• Intervention Usability Scale

  caregivers' rating of the usability of the intervention

  immediately post-intervention (Week 12)

Study Arms (2)

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.

Behavioral: MENU

Active control

ACTIVE COMPARATOR

Receiving access to online modules only

Behavioral: Online modules

Interventions

MENU BEHAVIORAL

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.

MENU group

Online modules BEHAVIORAL

Active control will receive 8 weekly online modules of their choosing

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Caregivers of children who have no concerns related to autism spectrum disorder
• Caregivers who are unable to provide informed consent

Sponsors & Collaborators

• University of Texas at Austin: lead
• Baylor University: collaborator

MeSH Terms

Conditions

Autistic Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: January 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share