Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03333629 |
| Other study ID # |
R01MH115715 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 29, 2017 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Drexel University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Autism spectrum disorder (ASD) is a serious neurodevelopmental disorder defined by impaired
social engagement and social communication, in addition to the presence of repetitive,
restricted, or stereotyped behaviors and interests. Although many cases of ASD can be
detected when children are less than two years old, the average age of diagnosis in the US is
still after the fourth birthday. However, evidence demonstrates that children who start
ASD-specific early intervention have better outcomes than children who do not start treatment
until later ages. In 2006 and 2007, American Academy of Pediatrics recommended three early
detection approaches to improve identification of children at risk for ASD: ongoing
developmental surveillance at every well-child check-up, routine broad developmental
screening at three infant/toddler ages, and ASD-specific screening at two toddler ages. When
these early detection strategies are used with all children attending well-child check-ups,
the age of ASD detection is lower, and children who are diagnosed have the opportunity to
start ASD-specific early intervention at younger ages than if they had not been detected. Yet
in 2016, the US Preventive Services Task Force (USPSTF) indicated that current evidence is
insufficient to recommend universal ASD screening, given the lack of experimental studies
demonstrating positive outcomes for treated children that are detected through screening. The
current study will address this gap. 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. The study will be conducted by
investigators from three sites: Drexel University; the University of California, Davis; and
the University of Connecticut. Local pediatric providers will be enrolled in the study, and
their practices 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. Children attending well-child visits at participating practices will
then be enrolled. Across all sites, 8,000 children will be recruited through their
participating pediatric practice. As part of the study, qualifying children will receive up
to one year of early intensive behavioral intervention, using an evidence-based manualized
treatment. Primary outcome measures will include children's cognitive functioning and ASD
symptom severity, which will be measured at multiple time points. Exploratory outcomes will
include children's adaptive functioning, kindergarten readiness, and social reciprocity, as
measured by experimental eye tracking and parent-child interaction ratings. This study also
will examine the impact of the screening intervention on physician attitudes and on parent
empowerment and stress. Finally, investigators will examine potential moderators of outcomes,
to determine whether initial symptom severity, cognitive ability, or socioeconomic status
affects children's long-term outcomes. 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.
