Your session is about to expire
← Back to Search
Remaking Recess for Autism (RR Trial)
N/A
Recruiting
Research Sponsored by Health Resources and Services Administration (HRSA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months, and 18 months
Awards & highlights
RR Trial Summary
This trial will compare the effects of three interventions when given with or without the UNITED implementation strategy.
Who is the study for?
This trial is for children aged 5-12 with Autism Spectrum Disorder (ASD) or other neurodevelopmental disorders who spend most of their day in general education and come from under-resourced families. Eligible schools are those receiving Title I funding or located in rural areas, and the family income must be below 250% of federal poverty guidelines. School personnel involved with these children can also participate.Check my eligibility
What is being tested?
The AIR-B4 study tests the 'Remaking Recess' intervention aimed at improving social engagement during recess for kids with ASD. It involves training school staff to implement play-based activities over approximately five hours throughout the school year, assessing effectiveness when combined with an implementation strategy called UNITED.See study design
What are the potential side effects?
Since this is a behavioral intervention involving professional development and coaching without medical treatments, there are no direct physical side effects expected from participating in Remaking Recess.
RR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 months, and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months, and 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stages of Implementation Completion (SIC)
Secondary outcome measures
Clinical Global Rating (CGI)
School Implementation Climate Scale
Social Network Survey- participants of survey will name key personnel that can be participants of the UNITED team for this intervention
+1 moreRR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: UNITEDExperimental Treatment1 Intervention
UNITED is premised on the idea that successful implementation in organizations like schools and early intervention systems requires a team-based approach, in which the team is thoughtfully assembled, develops a plan for implementation, assigns roles and responsibilities, and carefully tracks and supports implementation and sustainment in all its stages within a few meetings and ongoing coaching from the research staff.
Group II: Implementation as Usual (IAU)Active Control1 Intervention
The organizations will implement RR as usual. The research team will be available to provide support on the RR intervention as needed.
Find a Location
Who is running the clinical trial?
University of RochesterOTHER
837 Previous Clinical Trials
517,853 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
9,325 Patients Enrolled for Autism Spectrum Disorder
Drexel UniversityOTHER
150 Previous Clinical Trials
47,501 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
20,795 Patients Enrolled for Autism Spectrum Disorder
Health Resources and Services Administration (HRSA)Lead Sponsor
84 Previous Clinical Trials
151,223 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
1,984 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is either under 5 years old or over 12.I work at an elementary school, possibly as a teacher, aide, or playground staff.My child, aged 5-12, has ASD or NDD and we are under-resourced.I work at an elementary school, possibly as a teacher, aide, or playground staff.You are attending a Title I school or a rural school.My child, aged 5-12, has ASD or NDD and we are under-resourced.My parent or caregiver is not willing to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Implementation as Usual (IAU)
- Group 2: UNITED
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT04972838 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could members of the public participate in this experiment?
"As found on clinicaltrials.gov, the recruitment period for this trial is ongoing and began on July 11th 2021; its most recent update was recorded on October 8th 2021."
Answered by AI
Does my profile meet the criteria for participating in this medical experiment?
"This clinical trial has capacity for 264 participants aged 5 to 12 who possess a diagnosis of autism spectrum disorder. Additionally, they must spend the majority of their day in a general education classroom and be part of an under-resourced family with income below 250% of poverty rate as stated by federal guidelines. Furthermore, 112 elementary school personnel (e.g playground staff, teachers aides), 152 children diagnosed with ASD or NDD and parent/caregiver participation is necessary from those attending Title I or rural schools."
Answered by AI
How many participants have been recruited for this clinical investigation?
"To conduct this trial, 264 participants that meet the listed eligibility requirements must be recruited. Eligible candidates can enroll from University of Rochester in Rochester, New york and University of Pennsylvania in Philadelphia, Pennsylvania."
Answered by AI
Does this research involve participants over the age of 45?
"Participants aged 5-12 years may be eligible to join this clinical trial."
Answered by AI
Who else is applying?
What state do they live in?
Washington
Pennsylvania
What site did they apply to?
University of Washington
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
This is his mother’s.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- University of Washington: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger