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AIR-B4: Remaking Recess (RR) (RR)

Primary Purpose

Autism Spectrum Disorder, Neurodevelopmental Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remaking Recess (RR)
Sponsored by
Health Resources and Services Administration (HRSA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, playground, recess, inclusive school culture

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Rochester
  • University of PennsylvaniaRecruiting
  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UNITED

Implementation as Usual (IAU)

Arm Description

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.

The organizations will implement RR as usual. The research team will be available to provide support on the RR intervention as needed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 6, 2021
Last Updated
February 27, 2023
Sponsor
Health Resources and Services Administration (HRSA)
Collaborators
University of California, Davis, University of Kansas, University of Washington, University of Pennsylvania, University of Rochester, Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT04972838
Brief Title
AIR-B4: Remaking Recess (RR)
Acronym
RR
Official Title
Autism Intervention Research Network on Behavioral Health: Remaking Recess
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Resources and Services Administration (HRSA)
Collaborators
University of California, Davis, University of Kansas, University of Washington, University of Pennsylvania, University of Rochester, Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Neurodevelopmental Disorders
Keywords
autism, playground, recess, inclusive school culture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UNITED
Arm Type
Experimental
Arm Description
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.
Arm Title
Implementation as Usual (IAU)
Arm Type
Active Comparator
Arm Description
The organizations will implement RR as usual. The research team will be available to provide support on the RR intervention as needed.
Intervention Type
Behavioral
Intervention Name(s)
Remaking Recess (RR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stages of Implementation Completion (SIC)
Description
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.
Time Frame
through study completion, an average of 18 months
Secondary Outcome Measure Information:
Title
School Implementation Climate Scale
Description
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.
Time Frame
baseline,12 weeks, and 24 weeks
Title
Social Network Survey- participants of survey will name key personnel that can be participants of the UNITED team for this intervention
Description
Survey created by the research team to gather information about the key people in each organization that can better support the Remaking Recess intervention.
Time Frame
baseline, 12 months, and 18 months
Title
Teacher Perceptions Scale
Description
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.
Time Frame
baseline, 12 weeks, and 24 weeks
Title
Clinical Global Rating (CGI)
Description
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.
Time Frame
baseline, 12 weeks, and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie Kasari, PhD
Phone
310-825-8342
Email
kasari@gseis.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Consuelo Garcia, BS
Phone
310-825-4775
Email
cogarcia@mednet.ucla.edu
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Farash, PhD
Phone
585-275-0953
Email
sarah_farash@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Suzannah Iadarola, PhD
First Name & Middle Initial & Last Name & Degree
Lynne Levato, PhD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Blanch, MSEd
Phone
215-573-8472
Email
erica.blanch@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
David Mandell, PhD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Locke, PhD
Phone
216-616-6703
Email
jjlocke@uw.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
35842614
Citation
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.
Results Reference
derived

Learn more about this trial

AIR-B4: Remaking Recess (RR)

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