Last reviewed · How we verify
NCT04972838: RR
AIR-B4: Remaking Recess (RR)
NA trial testing Remaking Recess (RR) in Autism Spectrum Disorder in 264 participants. Participants enrolled and being followed up; not accepting new ones.
31 August 2025
Quick facts
| Lead sponsor | Health Resources and Services Administration (HRSA) |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 264 |
| Start date | 11 July 2021 |
| Primary completion | 31 August 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Remaking Recess (RR)
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Neurodevelopmental Disorders — all drugs for Neurodevelopmental Disorders →
Sponsor
Health Resources and Services Administration (HRSA)
Who can join
Adults 5 to 12, any sex, with Autism Spectrum Disorder or Neurodevelopmental Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Using Novel Implementation Tools for Evidence-based Intervention Delivery (UNITED) across public service systems for three evidence-based autism interventions in under-resourced communities: study protocol.
Locke J, Hassrick EM, Stahmer AC, Iadarola S, et al · · 2022 · cited 8× · PMID 35842614 · DOI 10.1186/s12888-022-04105-9 -
Characterizing social communication among minimally verbal children with autism: An application of item response theory.
Schlink A, Kasari C. · · 2024 · cited 3× · PMID 39152613 · DOI 10.1002/aur.3218
Verify or expand the search:
- PubMed search for NCT04972838
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Health Resources and Services Administration (HRSA) trials
Trials by the same sponsor.
- NCT04972851 — AIRB-4: Self-Determined Learning Model of Instruction · NA · active not recruiting
- NCT04972825 — AIR-B4: Mind the Gap · NA · active not recruiting
- NCT03711799 — Mind the Gap (AIR-B3) · NA · completed
- NCT03445520 — Building Better Bridges Randomized Control Trial · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04972838 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Health Resources and Services Administration (HRSA)
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04972838.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing