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SDLMI + UNITED Strategy for Autism (SDLMI 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
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
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months, and 18 months for reporting.

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 more

Awards & 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 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
871 Previous Clinical Trials
549,460 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
9,231 Patients Enrolled for Autism Spectrum Disorder
University of WashingtonOTHER
1,824 Previous Clinical Trials
1,912,997 Total Patients Enrolled
17 Trials studying Autism Spectrum Disorder
3,891 Patients Enrolled for Autism Spectrum Disorder
University of KansasOTHER
153 Previous Clinical Trials
331,383 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
914 Patients Enrolled for Autism Spectrum Disorder
University of PennsylvaniaOTHER
2,082 Previous Clinical Trials
42,726,972 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
4,209 Patients Enrolled for Autism Spectrum Disorder
Drexel UniversityOTHER
155 Previous Clinical Trials
47,864 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
20,781 Patients Enrolled for Autism Spectrum Disorder
Health Resources and Services Administration (HRSA)Lead Sponsor
85 Previous Clinical Trials
151,295 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
1,890 Patients Enrolled for Autism Spectrum Disorder
University of California, DavisOTHER
945 Previous Clinical Trials
4,755,782 Total Patients Enrolled
14 Trials studying Autism Spectrum Disorder
5,543 Patients Enrolled for Autism Spectrum Disorder

Media Library

Self-Determined Learning Model of Instruction (SDLMI) Clinical Trial Eligibility Overview. Trial Name: NCT04972851 — N/A
Self-Determined Learning Model of Instruction (SDLMI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04972851 — N/A
Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT04972851 — N/A
~60 spots leftby Aug 2025