NCT06559267

Brief Summary

The purpose of the proposed three-site study is to test whether an educator-level implementation strategy, coaching, with or without a school-level implementation strategy, school-based teams, will maximize paraeducators' use (fidelity and sustainment) of an evidence-based social engagement intervention, Remaking Recess (RR). RR aims to improve peer related social skills for autistic students and their non-autistic peers who are socially isolated or peripheral and need support during recess.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jul 2024Aug 2029

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

5.1 years

First QC Date

August 15, 2024

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Remaking Recess Fidelity

    This 20-item observation measure rates how well educators are observed to be using core Remaking Recess strategies with students on the playground. Minimum score 1, maximum score 5. Higher scores indicate better outcome.

    Baseline, 4 months, 8 months, 12 months, 16 months

Secondary Outcomes (10)

  • Playground Observation of Peer Engagement (POPE)

    Baseline, 4 months, 8 months, 12 months, 16 months

  • Friendship Survey

    Baseline, 4 months, 8 months

  • Teacher Perceptions Measure

    Baseline, 4 months, 8 months

  • Acceptability of Intervention Measure (AIM)

    Baseline, 4 months, 8 months, 12 months, 16 months

  • Cost Measure

    Baseline, 4 months, 8 months, 12 months, 16 months

  • +5 more secondary outcomes

Study Arms (2)

Remaking Recess

ACTIVE COMPARATOR

Remaking Recess is a school-based social engagement intervention designed to enhance elementary school contextual factors to better support peer engagement during recess. Remaking Recess is delivered to educators through direct training and in vivo coaching by a certified Remaking Recess Coach.

Behavioral: Remaking Recess

TEAM

EXPERIMENTAL

Schools that are randomized to the TEAM condition will receive an additional implementation support intervention. TEAM will leverage existing human resources in the school to specifically focus on developing an implementation blueprint to foster a supportive implementation context for paraeducators to use Remaking Recess.

Behavioral: Remaking RecessOther: TEAM

Interventions

Remaking RecessBEHAVIORAL

Remaking Recess (RR) is a school-based social engagement intervention designed to enhance elementary school contextual factors to better support peer engagement during recess. Remaking Recess is delivered to educators through direct training and in vivo coaching by a certified Remaking Recess Coach.

Also known as: RR
Remaking RecessTEAM
TEAMOTHER

Schools that are randomized to the TEAM condition will receive an additional implementation support intervention. TEAM will leverage existing human resources in the school to specifically focus on developing an implementation blueprint to foster a supportive implementation context for paraeducators to use Remaking Recess.

Also known as: TEAMS, school-based teams
TEAM

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students: Elementary aged students in K-5th grade who are autistic or have a neurodevelopmental disorder (Age 5-12)
  • Educators: Paraeducators, teachers, or other school personnel that work with K-5th grade students in a public school in the United States (Age 18+)

You may not qualify if:

  • Students or educators that have previously participated in Remaking Recess studies will not be eligible to enroll in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California Los Angeles

Los Angeles, California, 90095, United States

NOT YET RECRUITING

University of Oregon

Eugene, Oregon, 97403, United States

NOT YET RECRUITING

University of Washington

Seattle, Washington, 98115, United States

RECRUITING

Related Publications (1)

  • Locke J, Sridhar A, Shih W, Shire S, Eisman AB, Kim E, Du A, Espeland C, Kasari C. Study protocol for a hybrid type 3 effectiveness-implementation trial of a team-based implementation strategy to support educators' use of a social engagement intervention. Implement Sci. 2025 Jan 9;20(1):3. doi: 10.1186/s13012-024-01414-3.

MeSH Terms

Conditions

Autism Spectrum DisorderNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental Disorders

Study Officials

  • Freda Liu, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kemmerly Chipongian

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
(participants will be masked during randomization process, after randomization they will be informed which condition they receive. Outcomes assessors will be masked to randomization and randomization outcome to the best of our ability)
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: All schools that participate in the study will receive Remaking Recess. Additionally, half of the schools will be randomized to receive TEAM, an additional implementation support intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 19, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations