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Completed Phase 4 Interventional

Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes

ClinicalTrials.gov ID: NCT03333629

Public ClinicalTrials.gov record NCT03333629. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Connecting the Dots: An RCT Integrating Standardized ASD Screening, High-Quality Treatment, and Long-Term Outcomes

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03333629
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Drexel University
Other
Enrollment
2,087 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
16 Months to 58 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 28, 2017
Primary completion
Sep 5, 2023
Completion
Jun 29, 2024
Last update posted
Aug 15, 2024

2017 – 2024

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
University of California, Davis Sacramento California 95817
University of Connecticut Storrs Connecticut 06269
Drexel University Philadelphia Pennsylvania 19104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03333629, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 15, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03333629 live on ClinicalTrials.gov.

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