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NCT03333629 · ClinicalTrials.gov registry record · Phase 4
Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes
A Phase 4 study, sponsored by Drexel University.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,087
- Enrollment target
NCT03333629 is a Phase 4 study that has completed, run by Drexel University. The registered enrollment target is 2,087 participants.
The verdict
NCT03333629, a Phase 4 study, has completed, sponsored by Drexel University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,087 participants
- Enrollment target
Study Summary
Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests. The average age of diagnosis in the US is after the fourth birthday. However, children who start ASD-specific early intervention have better outcomes than children start later. The current study will address a gap identified by the US Prevention Services Task Force, namely that children detected through screening respond positively to early intervention. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. Local pediatric providers will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Across all sites, 8,000 children will be recruited through their participating pediatric practice. Qualifying children will receive up to one year of early intensive behavioral intervention, after getting an ASD diagnosis. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
Interventions
- BEHAVIORAL Enhanced early detection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,087 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03333629
The ClinicalTrials.gov registry entry for NCT03333629 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,087 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Drexel University, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enhanced early detection is the first listed.
NCT03333629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03333629 about?
NCT03333629 is a clinical study titled "Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes". Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests. The average age of diagnosis in the US is after the fourth birthday. However, children who start ASD-specific early intervention have ...
What is the current status of trial NCT03333629?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,087 participants. The study started on 2017-11-29. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT03333629?
The interventions under investigation include: Enhanced early detection (BEHAVIORAL).
Who is sponsoring clinical trial NCT03333629?
This trial is sponsored by Drexel University, which has 92 total clinical trials registered on ClinicalTrials.gov.
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