Development of MENU Protocol

Sponsor
University of Texas at Austin
Study ID
NCT07319234
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Online modules — BEHAVIORAL
    Active control will receive 8 weekly online modules of their choosing

Study Details

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.

Key Dates

First listed
Jan 6, 2026
Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Sep 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MENU group
    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.
  • Active Comparator: Active control
    Receiving access to online modules only

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) ]

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