Behavioral Intervention
Mind the Gap for Autism Spectrum Disorder
University of Rochester, Rochester, NY
Targeting 3 different conditionsMind the GapN/ARecruitingResearch 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
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline, 12 months, and 18 months
Awards & highlights
No Placebo-Only Group
Study 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.
Eligible Conditions
- Autism Spectrum Disorder
- Neurodevelopmental Disorders
- Autism
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 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 site
Who is running the clinical trial?
University of PennsylvaniaOTHER
1,926 Previous Clinical Trials
41,921,523 Total Patients Enrolled
13 Trials studying Autism Spectrum Disorder
3,599 Patients Enrolled for Autism Spectrum Disorder
Drexel UniversityOTHER
141 Previous Clinical Trials
46,216 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
20,751 Patients Enrolled for Autism Spectrum Disorder
University of California, DavisOTHER
874 Previous Clinical Trials
5,026,929 Total Patients Enrolled
14 Trials studying Autism Spectrum Disorder
5,590 Patients Enrolled for Autism Spectrum Disorder
University of WashingtonOTHER
1,658 Previous Clinical Trials
1,582,625 Total Patients Enrolled
13 Trials studying Autism Spectrum Disorder
3,330 Patients Enrolled for Autism Spectrum Disorder
Health Resources and Services Administration (HRSA)Lead Sponsor
82 Previous Clinical Trials
111,396 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
1,940 Patients Enrolled for Autism Spectrum Disorder
University of RochesterOTHER
815 Previous Clinical Trials
514,803 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
9,285 Patients Enrolled for Autism Spectrum Disorder
University of KansasOTHER
139 Previous Clinical Trials
323,249 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
914 Patients Enrolled for Autism Spectrum Disorder
Media Library
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
18 - 65
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?
Patient
Why did patients apply to this trial?
There are far too few studies available for adults on the spectrum.
Patient