School-based Paraeducator Education for Engagement at Recess (SPEER)

August 11, 2025 updated by: Freda Liu, University of Washington
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kemmerly Chipongian
  • Phone Number: 206-543-3750
  • Email: chipokem@uw.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • University of California Los Angeles
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Not yet recruiting
        • University of Oregon
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98115
        • Recruiting
        • University of Washington
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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+)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Remaking Recess
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
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.
Other Names:
  • RR
Experimental: TEAM
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 Recess
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.
Other Names:
  • RR
Other: TEAM
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.
Other Names:
  • TEAMS
  • school-based teams

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Remaking Recess Fidelity
Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Playground Observation of Peer Engagement (POPE)
Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months
This observation-based instrument measures children's engagement with activities and peers. It rates children's engagement states and the frequency within a set amount of time.
Baseline, 4 months, 8 months, 12 months, 16 months
Friendship Survey
Time Frame: Baseline, 4 months, 8 months
This 5-item free response survey asking students to identify their preferred peers at school. The results of the survey will be analyzed to identify student social network centrality in their classroom (Nuclear, Secondary, Peripheral, or Isolated).
Baseline, 4 months, 8 months
Teacher Perceptions Measure
Time Frame: Baseline, 4 months, 8 months
This 12-item measure asks teachers to report on their perceptions of their target student's social skills. Minimum score 1, maximum score 3. Higher scores indicate better outcome.
Baseline, 4 months, 8 months
Acceptability of Intervention Measure (AIM)
Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months
This 12-item self-report measure asks educators to rate how acceptable the interventions (Remaking Recess and TEAM) were. Minimum score 1, maximum score 5. Higher scores indicate better outcome.
Baseline, 4 months, 8 months, 12 months, 16 months
Cost Measure
Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months
This survey measure asks educators how much time they spent on study-related procedures (Remaking Recess and TEAM) each week. The measure then calculates the average dollar cost each week of study-related procedures based off of the educator's salary in order to better understand the cost of implementation and intervention.
Baseline, 4 months, 8 months, 12 months, 16 months
Provider Report of Sustainment Scale (PRESS)
Time Frame: 12 months, 16 months
This 3-item self-report measure asks educators to reflect on the sustainment of the use of the target intervention (Remaking Recess) at their school. Minimum score 0, maximum score 4. Higher scores indicate better outcome.
12 months, 16 months
School Implementation Leadership Scale (S-ILS)
Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months
This 25-item measure captures educator perceptions of their school leadership and how well the leadership supports the use of the intervention (Remaking Recess). Minimum score 0, maximum score 4. Higher scores indicate better outcome.
Baseline, 4 months, 8 months, 12 months, 16 months
School Implementation Climate Scale (SICS)
Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months
This 21-item measure captures educator perceptions of their school culture and how well the intervention (Remaking Recess) fits in. Minimum score 0, maximum score 4. Higher scores indicate better outcome.
Baseline, 4 months, 8 months, 12 months, 16 months
Team Process Survey Measure (TPS)
Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months
A 10-item self-report measure to capture team process. Minimum score 1, maximum score 5. Higher scores indicate better outcome.
Baseline, 4 months, 8 months, 12 months, 16 months
Quality of Play Questionnaire
Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months
A 19-item measure for parents/caregivers to complete about their child's playdates. Items 1-17 are a numerical rating of how much time a child spends on an activity in their play, with score ranging from a minimum of 0 to maximum of 3. Items 18-19 are a free response numerical frequency rating for parents to report on the number of playdates their child had in the last month.
Baseline, 4 months, 8 months, 12 months, 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Freda Liu, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00020326
  • R324A240031 (Other Grant/Funding Number: Institute of Education Sciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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