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SDLMI + UNITED Strategy for Autism (SDLMI 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
SDLMI Trial Summary
This trial will compare the effectiveness of each intervention with and without the addition of our implementation strategy, UNITED. UNITED is a remote delivery of professional development modules specific to the intervention and active coaching as dictated by the intervention procedures.
Who is the study for?
This trial is for school staff and adolescents aged 13-19 with Autism Spectrum Disorder (ASD) or Neurodevelopmental Disorders (NDD), from under-resourced families. Eligible participants include those attending Title I schools, have a family income below 250% of the federal poverty guidelines, and have an official ASD/NDD diagnosis.Check my eligibility
What is being tested?
The AIRB-4 study tests the Self-Determined Learning Model of Instruction (SDLMI) for adolescents with ASD. It involves training school personnel to help students set and achieve their own goals over one school year, requiring about 47 hours from staff and around 25 hours from students.See study design
What are the potential side effects?
Since this intervention is educational rather than medical, it does not involve typical drug side effects. However, there may be indirect effects related to changes in behavior or stress levels due to new learning strategies.
SDLMI 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
Goal Attainment Scaling (GAS)
School Implementation Climate Scale
Self-Determination Inventory (SDI-SR)
+1 moreSDLMI 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 SDLMI as usual. The research team will be available to provide support on the SDLMI intervention as needed.
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Who is running the clinical trial?
University of RochesterOTHER
834 Previous Clinical Trials
517,791 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
9,231 Patients Enrolled for Autism Spectrum Disorder
University of WashingtonOTHER
1,732 Previous Clinical Trials
1,841,756 Total Patients Enrolled
13 Trials studying Autism Spectrum Disorder
3,280 Patients Enrolled for Autism Spectrum Disorder
University of KansasOTHER
147 Previous Clinical Trials
325,503 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
914 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 13 and 19 years old, do not have ASD or NDD, and my family has adequate resources.I am between 13-19 years old with ASD or NDD and come from a low-resource family.I am between 13-19 years old with ASD or NDD and come from a family with limited resources.The family income is below 250% of the poverty guideline.You are attending a Title I school or a rural school.A doctor or specialist has diagnosed you with Autism Spectrum Disorder (ASD).My parent or caregiver is not willing to participate.My caregiver is willing to be involved in the study.
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: NCT04972851 — 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 for the study open at this moment?
"Clinicaltrials.gov confirms that recruitment for this medical study is ongoing, with the trial having been posted on August 4th 2021 and updated as of October 8th 2021."
Answered by AI
How many individuals are taking part in this experiment?
"This medical study necessitates the enlistment of 358 qualified participants. Those interested in taking part can do so at either University of Kansas (Lawrence, KS) or UC Davis MIND Institute (Davis, CA)."
Answered by AI
Who else is applying?
What state do they live in?
New York
Pennsylvania
Oregon
Other
How old are they?
18 - 65
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Kansas
University of Washington
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
What is it? How long will I have to stay? How long does it take rolled? What do I need to do to be successful in this trial and is there anything that you can do to help me as well?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have ASD, among 6 other disorders, and I am out of work, waiting for my disability application, and need money for bills and rent.
PatientReceived 1 prior treatment
So I believe I had autism Medicaid and I’m 40 years old and I have not been diagnosed but I believe I should be and my son is eight years old and I’ve he’s had trauma from his dad, but more so he is on a high functioning, autistic scale, and I just need to get him diagnosed to get some help her figure out what I’m doing wrong you know.
PatientReceived 2+ prior treatments
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