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NCT04972838 · ClinicalTrials.gov registry record · NA
AIR-B4: Remaking Recess (RR)
A NA study of Autism Spectrum Disorder and Neurodevelopmental Disorders, sponsored by Health Resources and Services Administration (HRSA).
- Active
- Registry status
- NA
- Development phase
- 264
- Enrollment target
- 3
- Study locations
NCT04972838: Active NA study of Autism Spectrum Disorder and Neurodevelopmental Disorders, sponsored by Health Resources and Services Administration (HRSA).
NCT04972838 is a NA study of Autism Spectrum Disorder and Neurodevelopmental Disorders that is active but no longer recruiting, run by Health Resources and Services Administration (HRSA). The registered enrollment target is 264 participants, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (97% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04972838, a NA study of Autism Spectrum Disorder and Neurodevelopmental Disorders, is active but no longer recruiting, sponsored by Health Resources and Services Administration (HRSA).
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 264 participants
- Enrollment target
- 3
- Study locations
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 our 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. 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 Remaking Recess, school personnel will be working with children with ASD using the Remaking Recess Intervention (play-based intervention done during recess). School personnel will be trained to implement the intervention. The total time commitment for the school personnel is about 30 hours. The total time commitment for the parents with ASD who will sign consents and fill out a demographic survey is about 15 minutes. The total time commitment for children with ASD or other neurodevelopmental disorders (NDD) is about 5 hours during their regularly scheduled recess period throughout the school year.
Primary Outcome
ool developed by the Oregon Social Learning Center, is an 8 stage tool of implementation process and milestones, with stages spanning three implementation phases (pre-implementation, implementation, and sustainability.
Conditions Studied
Interventions
- BEHAVIORAL Remaking Recess (RR)
Study Locations (3)
New York
- University of Rochester - Rochester
Pennsylvania
- University of Pennsylvania - Philadelphia
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2021-07-11 |
| Est. Completion | 2025-12-01 |
| Phase | NA |
What the registry record for NCT04972838 still lists
NCT04972838 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (97% higher).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Remaking Recess (RR) is the first listed.
NCT04972838 reports a single indexed study location in New York, Pennsylvania, Washington.
Frequently Asked Questions
What is clinical trial NCT04972838 about?
NCT04972838 is a clinical study titled "AIR-B4: Remaking Recess (RR)". 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 our implementation strategy, UNITED. In all groups, the research team will train community practiti...
What is the current status of trial NCT04972838?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 264 participants. The study started on 2021-07-11. Estimated completion is 2025-12-01.
What conditions does trial NCT04972838 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Neurodevelopmental Disorders.
What interventions are being tested in trial NCT04972838?
The interventions under investigation include: Remaking Recess (RR) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04972838?
This trial is sponsored by Health Resources and Services Administration (HRSA), which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04972838 being conducted?
This trial has 3 study locations across New York, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04972838's enrollment target sits among peer trials
264 32nd of 224 higher than 193 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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