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NCT03333629CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 16 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
2087 (actual)
First submitted
8 Sept 2017
Start date
29 Nov 2017
Primary completion date
6 Sept 2023
Lead sponsor
Drexel University
Diseases
Autism
NCT number
NCT03333629

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 2087
  • From 29 Nov 2017 to the primary completion date, 6 Sept 2023
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • child has severe sensory or motor deficit that precludes completing standardized evaluation

Who the study is looking for

  • child attended 18 m visiting at participating pediatric practice
  • legal guardian is fluent in English or Spanish

Age in the registry: 16 months to 58 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Drexel University
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of California - Davis
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
University of Connecticut
Coordinator of this site? Confirm its status
StorrsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.