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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: Completed Phase 4 study, sponsored by Drexel University.
NCT03333629 is a Phase 4 study that has completed, run by Drexel University. The registered enrollment target is 2,087 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (303% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ASD symptom severity will be measured with the Brief Observation of Social Communication Change (BOSCC)
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 |
What the finished NCT03333629 record still lists
NCT03333629 is an interventional study that assigns participants to a tested intervention. Its 2,087 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (303% higher).
The record links to 0 conditions, and to 1 intervention - of which Enhanced early detection is the first listed.
NCT03333629 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03333629's enrollment target sits among peer trials
2,087 34th of 2000 higher than 1,967 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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