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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 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.

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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.

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

FieldValue
Enrollment Target 264 participants
Start Date 2021-07-11
Est. Completion 2025-12-01
Phase NA

What the Registry Record Tells You About NCT04972838

The ClinicalTrials.gov registry entry for NCT04972838 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (97% higher). The listed sponsor is Health Resources and Services Administration (HRSA), which has 8 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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