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Behavioral Intervention
Mind the Gap Intervention for Autism (MTG Trial)
N/A
Waitlist Available
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
No Placebo-Only Group
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stages of Implementation Completion (SIC)
Secondary study objectives
Caregiver Satisfaction Survey
Change in Coaching Session Data Form from month to month
Family Empowerment Scale (Koren, DeChillo & Friesen, 1992)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,084 Previous Clinical Trials
42,726,225 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
4,259 Patients Enrolled for Autism Spectrum Disorder
Drexel UniversityOTHER
156 Previous Clinical Trials
47,964 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
20,831 Patients Enrolled for Autism Spectrum Disorder
University of California, DavisOTHER
946 Previous Clinical Trials
4,755,822 Total Patients Enrolled
14 Trials studying Autism Spectrum Disorder
5,593 Patients Enrolled for Autism Spectrum Disorder
University of WashingtonOTHER
1,831 Previous Clinical Trials
1,907,261 Total Patients Enrolled
17 Trials studying Autism Spectrum Disorder
3,941 Patients Enrolled for Autism Spectrum Disorder
Health Resources and Services Administration (HRSA)Lead Sponsor
85 Previous Clinical Trials
151,345 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
1,940 Patients Enrolled for Autism Spectrum Disorder
University of RochesterOTHER
872 Previous Clinical Trials
549,789 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
9,281 Patients Enrolled for Autism Spectrum Disorder
University of KansasOTHER
154 Previous Clinical Trials
331,394 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
964 Patients Enrolled for Autism Spectrum Disorder
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.
Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT04972825 — N/A