What side effects are associated with this type of intervention?

Behavioral and educational interventions, such as the play-based Remaking Recess program, are generally considered safe and have minimal side effects. These interventions focus on improving social skills, communication, and peer interactions through structured play and guided activities. The most common side effects are typically mild and may include temporary increases in anxiety or frustration as children adapt to new routines and social expectations. However, these effects are usually short-lived and can be managed with appropriate support and adjustments to the intervention.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of symptoms associated with Autism Spectrum Disorder (ASD), primarily focusing on irritability and behavioral issues rather than social or peer engagement. Notable FDA-approved medications include risperidone and aripiprazole, which are used to manage irritability in children with ASD. However, there are no FDA-approved drugs specifically targeting social or peer engagement improvements similar to the play-based intervention studied in the Remaking Recess trial. Most interventions for social skills in ASD are behavioral and educational rather than pharmacological.

What other types of research exist?

Promising, novel alternatives to Remaking Recess for improving social/peer engagement in children with ASD include: 1) SENSE Theatre®: A peer-mediated, theater-based program that has shown significant improvements in social and communication skills. 2) Peer-Mediated LEGO® Play Intervention: This involves structured LEGO® activities with typically developing peers to enhance social interactions. 3) Animal-Assisted Therapy: Although more research is needed, initial studies suggest that the presence of animals can reduce social stress and increase social behaviors in children with ASD.

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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

Must not have

Children under the age of 5 or over 12

Parent/Caregiver not willing to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months, and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Remaking Recess, a program that helps children with autism or developmental disorders engage socially during school recess. It targets children aged 5-12 and involves training school staff to support these children in social interactions through structured play activities. Remaking Recess is designed to improve peer engagement for children with autism spectrum disorder (ASD) during recess.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child is either under 5 years old or over 12.

Select...

My parent or caregiver is not willing to participate.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stages of Implementation Completion (SIC)

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Play-based interventions, such as the Remaking Recess program, work by creating structured opportunities for children with Autism Spectrum Disorder (ASD) to engage in social interactions within natural settings like school recess. These interventions typically involve training school personnel to facilitate and encourage peer interactions, thereby improving social skills and peer engagement. The mechanisms of action include modeling appropriate social behaviors, providing prompts and reinforcement, and creating a supportive environment that reduces anxiety and promotes positive social experiences. This approach is crucial for ASD patients as it helps them develop essential social skills, enhances their ability to form meaningful relationships, and improves their overall quality of life. Additionally, early and intensive interventions that are individualized and involve family participation are associated with better outcomes, making these strategies vital for the developmental progress of children with ASD.

A pilot tennis program for training fitness and social behaviors in individuals with autism spectrum disorder.Could You Give Me the Blue Brick? LEGO®-Based Therapy as a Social Development Program for Children with Autism Spectrum Disorder: A Systematic Review.A Multisite Randomized Controlled Two-Phase Trial of the Early Start Denver Model Compared to Treatment as Usual.