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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
Must not have
Parent/Caregiver not willing to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months, and 18 months
Awards & highlights
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My parent or caregiver is not willing to participate.
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
Goal Attainment Scaling (GAS)
School Implementation Climate Scale
Self-Determination Inventory (SDI-SR)
+1 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of RochesterOTHER
859 Previous Clinical Trials
538,345 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
9,231 Patients Enrolled for Autism Spectrum Disorder
University of WashingtonOTHER
1,791 Previous Clinical Trials
1,905,148 Total Patients Enrolled
16 Trials studying Autism Spectrum Disorder
3,840 Patients Enrolled for Autism Spectrum Disorder
University of KansasOTHER
150 Previous Clinical Trials
326,361 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
914 Patients Enrolled for Autism Spectrum Disorder
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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.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
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