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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 months, and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months, and 18 months
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 moreMTG 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child, aged 2-8, has ASD or NDD, hasn't received ASD-specific services outside school, and our family income is below 250% of the federal poverty level. We speak English, Korean, or Spanish.I do not work in an organization with a peer navigator role and cannot meet the study's requirements.My child, aged 2-8, has autism or a neurodevelopmental disorder.agency staff (coordinators, directors, managers, supervisors) working on community organizations with peer navigator capacity e.g.My child, aged 2-8, has ASD or NDD and we haven't used specific ASD services outside school. Our family income is below 250% of the poverty line. We speak English, Korean, or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: UNITED
- Group 2: Implementation as Usual (IAU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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
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