AIR-B4: Mind the Gap

NCT04972825 | Active Not Recruiting

• 1 other identifier: 20-001403
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 4

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 an 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 during a time span of 6 months. 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 MTG, peer navigators (staff working in an organization that already works with parents) and parents (with children with ASD) will meet via phone or video conference for up to 12 sessions within a 6 month span (an hour each time). They will go over sessions that were created by the research group that help parents understand the system of acquiring services. The total time commitment for peer navigators is about 18 hours and for parents with children with ASD is about 8.5 hours. Identified families connected to the community organization will be matched with one peer navigator who will then guide and support the caregiver through completion of the MTG modules with active coaching of the family. Family needs and preferences will guide topic selection. Active coaching will occur via zoom, or over the phone, based on family preference and some recorded sessions will be shared with the research group for analyses. Mind the Gap will be available in English, Spanish, and Korean.

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders

Keywords

new diagnosis; autism services; Mind the Gap; navigating program

Outcome Measures

Primary Outcomes (1)

• Stages of Implementation Completion (SIC)

  Tool 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. The research staff will enter dates once milestones are completed.

  through study completion, an average of 18 months

Secondary Outcomes (6)

• School Implementation Climate Scale (SICS)

  baseline (entry), 12 months, and 18 months

• Change in Coaching Session Data Form from month to month

  monthly from baseline and up to 6 months after baseline

• Family Empowerment Scale (Koren, DeChillo & Friesen, 1992)

  baseline and 6 months

• WHOQOL scale

  baseline

• Social Network Survey

  baseline, 12 months, and 18 months

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: Mind the Gap

Implementation as Usual (IAU)

ACTIVE COMPARATOR

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

Behavioral: Mind the Gap

Interventions

Mind the Gap BEHAVIORAL

This intervention will help parents with children newly diagnosed with autism or other neurodevelopmental disorders learn how to navigate the system of acquiring services for their child. These parents will be assisted by a coach, an employee at the child's agency, that will help them through this process.

Implementation as Usual (IAU); UNITED

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• families of children age 2 to 8 with ASD or NDD. no receipt of ASD specific services outside of school (family may still qualify if child is connected with a regional center/EI, but not yet receiving services), defined as (a) services obtained through insurance based on having an ASD diagnosis; or (b) receiving services through 0-3 that can only be accessed with an ASD dx (e.g., intensive in home EIBI); (3) family income is under 250% of the federal guidelines for poverty rate; (4) English, Korean or Spanish speaking.
• agency staff (coordinators, directors, managers, supervisors) working on community organizations with peer navigator capacity e.g. parent support centers; FQHC; community clinics; faith-based agencies) serving children with ASD and other NDD (neurodevelopment disorders).
• peer navigators which include people working at participating community organizations with peer navigator capacity (e.g. parent support centers; FQHC; community clinics; faith-based agencies) serving children with ASD and other NDD (neurodevelopment disorders)

You may not qualify if:

• families with children under the age of 2 or over 8 years of age, does not have ASD or NDD; parents are not fluent in English, Spanish, or Korean; child already receiving services accessed with an ASD diagnosis; family income is over 250% federal guidelines for poverty rate
• Agency Staff: people not working in an organization that has a peer navigator capacity; cannot commit to the requirements of the study.
• Peer Navigators: people not working in an organization that has a peer navigator capacity; cannot commit to the times and requirements of the study

Sponsors & Collaborators

• Health Resources and Services Administration (HRSA): lead
• University of Rochester: collaborator
• University of Kansas: collaborator
• University of Pennsylvania: collaborator
• Drexel University: collaborator
• University of California, Davis: collaborator
• University of Washington: collaborator

Study Sites (4)

UC Davis MIND Institute

Davis, California, 95817, United States

Location

University of Kansas

Lawrence, Kansas, 66045, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

UPENN

Philadelphia, Pennsylvania, 19104, 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.

  PMID: 35842614 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders

Interventions

mtg protein, Drosophila

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental 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 1, 2021
• First Posted: July 22, 2021
• Study Start: July 29, 2021
• Primary Completion: December 23, 2025
• Study Completion: January 5, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

US (4)