Autism Spectrum DisorderSPEERNCT06559267
School-based Paraeducator Education for Engagement at Recess
A study testing Remaking Recess and TEAM in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by University of Washington at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Neurodevelopmental Disorders
- What is being tested?
- Remaking Recess and TEAM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2024to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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+)
Who cannot join
- Students or educators that have previously participated in Remaking Recess studies will not be eligible to enroll in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Oregon
Eugene, Oregon, 97403
Stephanie Shire, PhD, 541-346-2141, sshire@uoregon.edu
- Not yet recruiting
University of California Los Angeles
Los Angeles, California, 90095
Consuelo Garcia, 310-825-4775, cogarcia@mednet.ucla.edu
- Recruiting
University of Washington
Seattle, Washington, 98115
Freda Liu, PhD, (206) 987-3295, fredaliu@uw.edu
Kemmerly Chipongian, (206) 543-3750, chipokem@uw.edu
About this study
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.
- Being tested
- Remaking Recess, TEAM
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remaking RecessBehavioural
Also called RR
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.
TEAMOther
Also called TEAMS, school-based teams
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Remaking Recess; Other: TEAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months
Secondary outcomes (10)
Playground Observation of Peer Engagement (POPE)
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months
Friendship Survey
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).
Measured: Baseline, 4 months, 8 months
Teacher Perceptions Measure
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.
Measured: Baseline, 4 months, 8 months
Acceptability of Intervention Measure (AIM)
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months
Cost Measure
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months
Provider Report of Sustainment Scale (PRESS)
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.
Measured: 12 months, 16 months
School Implementation Leadership Scale (S-ILS)
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months
School Implementation Climate Scale (SICS)
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months
Team Process Survey Measure (TPS)
A 10-item self-report measure to capture team process. Minimum score 1, maximum score 5. Higher scores indicate better outcome.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months
Quality of Play Questionnaire
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Jul 2024
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Freda Liu, University of Washington
- Investigators
- Freda Liu, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559267
- Sponsor's protocol ID
- STUDY00020326
- Other IDs
- R324A240031
- Acronym
- SPEER
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39789610
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Paraeducator Education for Engagement at Recess
- ClinicalTrials.gov ID
- NCT06559267
- Acronym / sponsor ID
- SPEER / STUDY00020326
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remaking Recess | Active comparator | Behavioral: Remaking RecessRemaking 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. |
| TEAM | Experimental | Behavioral: Remaking Recess, Other: TEAMSchools 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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+)
Key exclusion criteria (1 listed)
- Students or educators that have previously participated in Remaking Recess studies will not be eligible to enroll in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remaking RecessAlso: RRRemaking 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. | Behavioural | Remaking Recess, TEAM |
| TEAMAlso: TEAMS, school-based teamsSchools 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 | TEAM |
Primary outcome
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.
10 secondary outcomes
Playground Observation of Peer Engagement (POPE)
Time frame: Baseline, 4 months, 8 months, 12 months, 16 months
Friendship Survey
Time frame: Baseline, 4 months, 8 months
Teacher Perceptions Measure
Time frame: Baseline, 4 months, 8 months
Acceptability of Intervention Measure (AIM)
Time frame: Baseline, 4 months, 8 months, 12 months, 16 months
Cost Measure
Time frame: Baseline, 4 months, 8 months, 12 months, 16 months
Provider Report of Sustainment Scale (PRESS)
Time frame: 12 months, 16 months
School Implementation Leadership Scale (S-ILS)
Time frame: 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
Team Process Survey Measure (TPS)
Time frame: Baseline, 4 months, 8 months, 12 months, 16 months
Quality of Play Questionnaire
Time frame: Baseline, 4 months, 8 months, 12 months, 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 39789610Locke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Freda Liu, PhD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remaking Recess and TEAM in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kemmerly Chipongian (206-543-3750, chipokem@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remaking Recess Fidelity (time frame: Baseline, 4 months, 8 months, 12 months, 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06559267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.