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Behavioral Intervention

Mind the Gap Intervention for Autism (MTG Trial)

N/A
Recruiting
Research Sponsored by Health Resources and Services Administration (HRSA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months, and 18 months
Awards & highlights

MTG Trial Summary

This trial will study the effects of three interventions, Mind the Gap, Remaking Recess, and Self Determination Learning Model of Instruction, with and without the addition of an implementation strategy, UNITED.

Who is the study for?
This trial is for families with children aged 2 to 8 diagnosed with Autism Spectrum Disorder (ASD) or Neurodevelopmental Disorders (NDD), who haven't started ASD-specific services outside of school. Participants must speak English, Korean, or Spanish and have a family income below 250% of the federal poverty level. Peer navigators from community organizations serving children with ASD/NDD are also eligible.Check my eligibility
What is being tested?
The 'Mind the Gap' intervention is being tested, which involves peer navigators helping parents understand how to access services for their child with ASD/NDD through up to 12 sessions over six months via phone or video conference. The effectiveness of additional implementation strategies will also be evaluated.See study design
What are the potential side effects?
Since this trial focuses on educational and support interventions rather than medical treatments, traditional side effects are not applicable. However, participants may experience varying levels of stress or emotional impact related to navigating care systems.

MTG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stages of Implementation Completion (SIC)
Secondary outcome measures
Caregiver Satisfaction Survey
Change in Coaching Session Data Form from month to month
Family Empowerment Scale (Koren, DeChillo & Friesen, 1992)
+3 more

MTG Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: UNITEDExperimental Treatment1 Intervention
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.
Group II: Implementation as Usual (IAU)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
1,994 Previous Clinical Trials
42,878,935 Total Patients Enrolled
4 Trials studying Neurodevelopmental Disorders
2,513 Patients Enrolled for Neurodevelopmental Disorders
Drexel UniversityOTHER
148 Previous Clinical Trials
47,084 Total Patients Enrolled
2 Trials studying Neurodevelopmental Disorders
622 Patients Enrolled for Neurodevelopmental Disorders
University of California, DavisOTHER
909 Previous Clinical Trials
4,703,822 Total Patients Enrolled
2 Trials studying Neurodevelopmental Disorders
622 Patients Enrolled for Neurodevelopmental Disorders

Media Library

Mind the Gap (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04972825 — N/A
Neurodevelopmental Disorders Research Study Groups: UNITED, Implementation as Usual (IAU)
Neurodevelopmental Disorders Clinical Trial 2023: Mind the Gap Highlights & Side Effects. Trial Name: NCT04972825 — N/A
Mind the Gap (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04972825 — N/A
Neurodevelopmental Disorders Patient Testimony for trial: Trial Name: NCT04972825 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this medical trial?

"Correct. According to the information found on clinicaltrials.gov, enlistment for this medical trial continues; it was first posted July 29th 2021 and last edited July 25th 2022."

Answered by AI

To what extent is this medical trial accommodating participants?

"This trial requires 308 qualified and eligible patients, who can enrol from the University of Kansas in Lawrence or the University of Rochester located in New york."

Answered by AI

Are there multiple facilities across America that are currently offering this investigation?

"Currently, 4 sites are administering this clinical trial; these locations can be found in Lawrence, Rochester, Philadelphia, and additional cities. To reduce any burden of traveling that may arise during participation, it is beneficial to choose the closest site to you."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Pennsylvania
New York
How old are they?
18 - 65
< 18
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Rochester
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

There are far too few studies available for adults on the spectrum.
PatientReceived 2+ prior treatments
~103 spots leftby Aug 2025