NCT04972838

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not 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

First Submitted

Initial submission to the registry

July 6, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

July 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

4.1 years

First QC Date

July 6, 2021

Last Update Submit

December 2, 2024

Conditions

Keywords

autismplaygroundrecessinclusive school culture

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 18 months

Secondary Outcomes (4)

  • School Implementation Climate Scale

    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

    baseline, 12 months, and 18 months

  • Teacher Perceptions Scale

    baseline, 12 weeks, and 24 weeks

  • Clinical Global Rating (CGI)

    baseline, 12 weeks, and 24 weeks

Study Arms (2)

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.

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.

Behavioral: Remaking Recess (RR)

Interventions

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.

Implementation as Usual (IAU)UNITED

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • elementary school personnel ( e.g. playground staff, classroom aides, teachers)
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Rochester

Rochester, New York, 14642, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum DisorderNeurodevelopmental DisordersAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Human Development and Psychology

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 22, 2021

Study Start

July 11, 2021

Primary Completion

August 31, 2025

Study Completion

December 1, 2025

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations