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AIR-B4: Mind the Gap
NCT04972825 · View on ClinicalTrials.gov ↗
Study Summary
The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of an implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention, and active coaching for up to 12 sessions as dictated by the intervention procedures during a time span of 6 months. The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self-advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities). For MTG, peer navigators (staff working in an organization that already works with parents) and parents (with children with ASD) will meet via phone or video conference for up to 12 sessions within a 6 month span (an hour each time). They will go over sessions that were created by the research group that help parents understand the system of acquiring services. The total time commitment for peer navigators is about 18 hours and for parents with children with ASD is about 8.5 hours. Identified families connected to the community organization will be matched with one peer navigator who will then guide and support the caregiver through completion of the MTG modules with active coaching of the family. Family needs and preferences will guide topic selection. Active coaching will occur via zoom, or over the phone, based on family preference and some recorded sessions will be shared with the research group for analyses. Mind the Gap will be availab
Conditions Studied
Interventions
- BEHAVIORAL Mind the Gap
Study Locations (4)
California
- UC Davis MIND Institute — Davis
Kansas
- University of Kansas — Lawrence
New York
- University of Rochester — Rochester
Pennsylvania
- UPENN — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2021-07-29 |
| Est. Completion | 2026-01-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04972825
The ClinicalTrials.gov registry entry for NCT04972825 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Health Resources and Services Administration (HRSA), which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention — of which Mind the Gap is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04972825 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Kansas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04972825 about?
NCT04972825 is a clinical study titled "AIR-B4: Mind the Gap". The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of an implementation strategy, UNITED. In all groups, the research team will train community practitio...
What is the current status of trial NCT04972825?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 308 participants. The study started on 2021-07-29. Estimated completion is 2026-01-05.
What conditions does trial NCT04972825 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Neurodevelopmental Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04972825?
The interventions under investigation include: Mind the Gap (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04972825?
This trial is sponsored by Health Resources and Services Administration (HRSA), which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04972825 being conducted?
This trial has 4 study locations across California, Kansas, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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