Autism Spectrum DisorderRRNCT04972838
AIR-B4: Remaking Recess (RR)
A study testing Remaking Recess (RR) in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Health Resources and Services Administration (HRSA) at 3 sites in United States.
Trial summary
The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of our implementation strategy, UNITED. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Neurodevelopmental Disorders
- What is being tested?
- Remaking Recess (RR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jul 2021to 1 Dec 2025
- 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 112 elementary school personnel ( e.g. playground staff, classroom aides, teachers)
- 152 children with ASD or NDD ages 5 to 12 and family is under-resourced.
- Expert medical diagnosis or educational classification of ASD
- Spend majority of the day (51%) in a general education classroom
- Under-resourced, defined by:
- Attending a Title I school (a school that receives federal funding to improve the performance of economically disadvantaged students)or rural school
- Family income is under 250% of the federal guidelines for poverty rate (i.e., meets federal requirements to qualify for free or reduced lunch)
- Parent/Caregiver willing to participate
Who cannot join
- Personnel at school not working with children with ASD or NDD Children: Under the age of 5 or over 12, does not spend majority of the day (51%) in general education classroom, does not have ASD or NDD and family is not under-resourced.
- No official ASD/NDD diagnosis. Parent/Caregiver not willing to participate.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14642
University of Washington
Seattle, Washington, 98195
About this study
Official title: Autism Intervention Research Network on Behavioral Health: Remaking Recess
The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of our implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention, and active coaching for up to 12 sessions as dictated by the intervention procedures.
The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self- advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities).
For Remaking Recess, school personnel will be working with children with ASD using the Remaking Recess Intervention (play-based intervention done during recess). School personnel will be trained to implement the intervention. The total time commitment for the school personnel is about 30 hours. The total time commitment for the parents with ASD who will sign consents and fill out a demographic survey is about 15 minutes. The total time commitment for children with ASD or other neurodevelopmental disorders (NDD) is about 5 hours during their regularly scheduled recess period throughout the school year.
Read the detailed description
Remaking Recess (RR) will include 112 elementary school personnel (e.g., playground staff, classroom aides, teachers); and 152 children with ASD/NDD ages 5-12 (2-5 per school).
RR targets school staff on the recess yard who supervise all students, including those with ASD/NDD. Training in RR will be remote, with all schools receiving a 60-90 minute didactic training during district professional development days which has been successful in previous studies. Active coaching (via remote methods, most likely zoom) will occur weekly with staff at school for 10-12 sessions during RR implementation with enrolled students. In prior studies, various school personnel (e.g., teachers, counselors, bus attendants, noontime aides, classroom assistants, and one-to-one paraprofessionals) have served as intervention agents.
There will be 3 assessment time points. At entry, the teachers/school staff will fill out Demographic, Implementation Climate Scale, Teacher perceptions, Clinical Global Impression (CGI-I), Social Network survey, and fidelity forms. The Staff Diary will be completed on an ongoing basis coinciding with coaching sessions. At the midpoint of the study (midpoint of school year) and at exit (end of the school year), they will fill out Implementation Climate Scale, Teacher perceptions, Clinical Global Impression (CGI-S, CGI-I), Social Network survey, and fidelity forms. The Social Network survey will be completed once in the following school year.
All participants in RR will be randomized to receive UNITED, exploratory implementation strategy, or implementation as usual (IAU). 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. To address these requirements, the research team combined two well-tested strategies. The first is social network analysis (SNA) through which we will systematically identify members of the team who will implement each intervention. The second is TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety), an evidence-based set of teamwork tools that optimizes target population outcomes by improving communication and teamwork skills. The research staff will approach the school leaders (2 at maximum) and explain Remaking Recess. After the school leaders agree to participate in the study, they will complete a site agreement to participate and then fill out the Social Network Assessment (SNA) to provide names, roles, and emails of staff at the agency that have significant roles in the school that relate to the Remaking Recess intervention. The research staff will then email these school personnel the SNA as well. After receiving the completed SNA assessments, the research team will randomize each organization to UNITED vs Implementation as Usual (IAU). The research team will use the data from these assessments to assess both arms of the study. Additionally, for those randomized to UNITED, Dr. Elizabeth McGhee Hassrick at Drexel University and her team, will provide the research sites the top 2-5 school personnel identified by the SNA as key for intervention implementation support. This team will be invited to participate in the UNITED implementation team. If they agree, they will complete a School Personnel Consent (UNITED/IAU) before beginning any UNITED training. For both UNITED and IAU schools, the school personnel that will be implementing Remaking Recess will fill out the Remaking Recess School Personnel Consent (Implementor) before beginning any study procedures.
- Being tested
- Remaking Recess (RR)
- Keywords
- autism, playground, recess, inclusive school culture
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remaking Recess (RR)Behavioural
Remaking Recess is a flexible, school-based social engagement intervention for students with autism and their peers. The research team will work with school personnel to deliver RR during recess. RR is tailored based on the needs of schools, students, and staff.
| Study group | Role | What they receive |
|---|---|---|
| UNITED | Experimental | 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. Receives: Behavioral: Remaking Recess (RR) |
| Implementation as Usual (IAU) | Active comparator | The organizations will implement RR as usual. The research team will be available to provide support on the RR intervention as needed. Receives: Behavioral: Remaking Recess (RR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of Implementation Completion (SIC)
ool developed by the Oregon Social Learning Center, is an 8 stage tool of implementation process and milestones, with stages spanning three implementation phases (pre-implementation, implementation, and sustainability.
Measured: through study completion, an average of 18 months
Secondary outcomes (4)
School Implementation Climate Scale
This scale was adapted to be used by the research team to gather information from the schools/agencies in the study about the use of evidence-based practices in their organizations. It is scaled from 0(not at all) to 4 (very great extent). Higher scores mean better outcomes.
Measured: baseline,12 weeks, and 24 weeks
Social Network Survey- participants of survey will name key personnel that can be participants of the UNITED team for this intervention
Survey created by the research team to gather information about the key people in each organization that can better support the Remaking Recess intervention.
Measured: baseline, 12 months, and 18 months
Teacher Perceptions Scale
Survey adapted by the research team to better understand the target student's behavior in the classroom and with his/her peers. It is rated using 1 as never, 2 as sometimes, and 3 as very often, with "3" as showing better outcome.
Measured: baseline, 12 weeks, and 24 weeks
Clinical Global Rating (CGI)
Survey created by the research team to show how the child is doing in terms of his/her social functioning. It is rated from "1" to "7", with "1" being "typical" and showing better outcomes and "7" as "extreme" and showing lowest outcome.
Measured: baseline, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start11 Jul 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion1 Dec 2025 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Resources and Services Administration (HRSA)
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis, University of Kansas, University of Washington, University of Pennsylvania, University of Rochester, Drexel University
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., Health Resources and Services Administration (HRSA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972838
- Sponsor's protocol ID
- 20-001993
- Acronym
- RR
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Locke J, Hassrick EM, Stahmer AC, Iadarola S, Boyd B, Mandell DS, Shih W, Hund L, Kasari C; AIR-B Network. Using Novel Implementation Tools for Evidence-based Intervention Delivery (UNITED) across public service systems for three evidence-based autism interventions in under-resourced communities: study protocol. BMC Psychiatry. 2022 Jul 16;22(1):478. doi: 10.1186/s12888-022-04105-9.
PubMed 35842614
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Intervention Research Network on Behavioral Health: Remaking Recess
- ClinicalTrials.gov ID
- NCT04972838
- Acronym / sponsor ID
- RR / 20-001993
- Keywords
- autism, playground, recess, inclusive school culture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Health Resources and Services Administration (HRSA)US federal agency
- Collaborators
- University of California, Davis, University of Kansas, University of Washington, University of Pennsylvania, University of Rochester, Drexel University
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Jul 2021 (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 AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of our implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention, and active coaching for up to 12 sessions as dictated by the intervention procedures.
The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self- advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities).
For Remaking Recess, school personnel will be working with children with ASD using the Remaking Recess Intervention (play-based intervention done during recess). School personnel will be trained to implement the intervention. The total time commitment for the school personnel is about 30 hours. The total time commitment for the parents with ASD who will sign consents and fill out a demographic survey is about 15 minutes. The total time commitment for children with ASD or other neurodevelopmental disorders (NDD) is about 5 hours during their regularly scheduled recess period throughout the school year.
Detailed description
Remaking Recess (RR) will include 112 elementary school personnel (e.g., playground staff, classroom aides, teachers); and 152 children with ASD/NDD ages 5-12 (2-5 per school).
RR targets school staff on the recess yard who supervise all students, including those with ASD/NDD. Training in RR will be remote, with all schools receiving a 60-90 minute didactic training during district professional development days which has been successful in previous studies. Active coaching (via remote methods, most likely zoom) will occur weekly with staff at school for 10-12 sessions during RR implementation with enrolled students. In prior studies, various school personnel (e.g., teachers, counselors, bus attendants, noontime aides, classroom assistants, and one-to-one paraprofessionals) have served as intervention agents.
There will be 3 assessment time points. At entry, the teachers/school staff will fill out Demographic, Implementation Climate Scale, Teacher perceptions, Clinical Global Impression (CGI-I), Social Network survey, and fidelity forms. The Staff Diary will be completed on an ongoing basis coinciding with coaching sessions. At the midpoint of the study (midpoint of school year) and at exit (end of the school year), they will fill out Implementation Climate Scale, Teacher perceptions, Clinical Global Impression (CGI-S, CGI-I), Social Network survey, and fidelity forms. The Social Network survey will be completed once in the following school year.
All participants in RR will be randomized to receive UNITED, exploratory implementation strategy, or implementation as usual (IAU). 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. To address these requirements, the research team combined two well-tested strategies. The first is social network analysis (SNA) through which we will systematically identify members of the team who will implement each intervention. The second is TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety), an evidence-based set of teamwork tools that optimizes target population outcomes by improving communication and teamwork skills. The research staff will approach the school leaders (2 at maximum) and explain Remaking Recess. After the school leaders agree to participate in the study, they will complete a site agreement to participate and then fill out the Social Network Assessment (SNA) to provide names, roles, and emails of staff at the agency that have significant roles in the school that relate to the Remaking Recess intervention. The research staff will then email these school personnel the SNA as well. After receiving the completed SNA assessments, the research team will randomize each organization to UNITED vs Implementation as Usual (IAU). The research team will use the data from these assessments to assess both arms of the study. Additionally, for those randomized to UNITED, Dr. Elizabeth McGhee Hassrick at Drexel University and her team, will provide the research sites the top 2-5 school personnel identified by the SNA as key for intervention implementation support. This team will be invited to participate in the UNITED implementation team. If they agree, they will complete a School Personnel Consent (UNITED/IAU) before beginning any UNITED training. For both UNITED and IAU schools, the school personnel that will be implementing Remaking Recess will fill out the Remaking Recess School Personnel Consent (Implementor) before beginning any study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UNITED | Experimental | Behavioral: Remaking Recess (RR)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. |
| Implementation as Usual (IAU) | Active comparator | Behavioral: Remaking Recess (RR)The organizations will implement RR as usual. The research team will be available to provide support on the RR intervention as needed. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 112 elementary school personnel ( e.g. playground staff, classroom aides, teachers)
- 152 children with ASD or NDD ages 5 to 12 and family is under-resourced.
- Expert medical diagnosis or educational classification of ASD
- Spend majority of the day (51%) in a general education classroom
- Attending a Title I school (a school that receives federal funding to improve the performance of economically disadvantaged students)or rural school
Key exclusion criteria (2 listed)
- Personnel at school not working with children with ASD or NDD Children: Under the age of 5 or over 12, does not spend majority of the day (51%) in general education classroom, does not have ASD or NDD and family is not under-resourced.
- No official ASD/NDD diagnosis. Parent/Caregiver not willing to participate.
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 Recess (RR)Remaking Recess is a flexible, school-based social engagement intervention for students with autism and their peers. The research team will work with school personnel to deliver RR during recess. RR is tailored based on the needs of schools, students, and staff. | Behavioural | Implementation as Usual (IAU), UNITED |
Primary outcome
Stages of Implementation Completion (SIC)
Time frame: through study completion, an average of 18 months
ool developed by the Oregon Social Learning Center, is an 8 stage tool of implementation process and milestones, with stages spanning three implementation phases (pre-implementation, implementation, and sustainability.
4 secondary outcomes
School Implementation Climate Scale
Time frame: baseline,12 weeks, and 24 weeks
Social Network Survey- participants of survey will name key personnel that can be participants of the UNITED team for this intervention
Time frame: baseline, 12 months, and 18 months
Teacher Perceptions Scale
Time frame: baseline, 12 weeks, and 24 weeks
Clinical Global Rating (CGI)
Time frame: baseline, 12 weeks, and 24 weeks
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 4 Dec 2024.
- Derived from this study: PubMed 35842614Locke J, Hassrick EM, Stahmer AC, Iadarola S, Boyd B, Mandell DS, Shih W, Hund L, Kasari C; AIR-B Network. Using Novel Implementation Tools for Evidence-based Intervention Delivery (UNITED) across public service systems for three evidence-based autism interventions in under-resourced communities: study protocol. BMC Psychiatry. 2022 Jul 16;22(1):478. doi: 10.1186/s12888-022-04105-9.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (RR) in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Health Resources and Services Administration (HRSA) 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 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stages of Implementation Completion (SIC) (time frame: through study completion, an average of 18 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 NCT04972838, 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 4 Dec 2024.