Status:
COMPLETED
Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
University of Southern California
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Autism Spectrum Disorder
Neurodevelopmental Disorders
Eligibility:
All Genders
11-16 years
Phase:
NA
Brief Summary
This study entails a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs). The objectives of t...
Detailed Description
Rationale: Providing intervention during infancy, before the full emergence of the symptoms that would lead to a diagnosis of ND based on a behavioral phenotype (e.g., autism spectrum disorder (ASD),...
Eligibility Criteria
Inclusion
- For the intervention trial: infant must meet risk criteria on the First Years Inventory (Calculated based on data collected in another study where risk status on the FYI was confirmed with follow up at 3 years. We empirically determined combinations of the two FYI domain scores that would sort respondents into "at-risk" and "not-at-risk." The resulting cut-points enabled us to sort children such that we capture about 1/3 of those who would go on to be confirmed as having a autism spectrum diagnosis while misclassifying less than 5% of the typically developing (TD) sample as at-risk). Infants also must score at least one s.d. below the mean on either the Receptive or Expressive subscale t scores AND meet the following SPA inclusion criteria on hyporeactivity (HYPO) or hyperreactivity (HYPER):
- "HYPO": Cut-point (equal or greater than) of 1.69 for Mean of the raw orienting score across 7 items, each with the range of 1 to 4 possible points)
- "HYPER": Cut-point (equal or greater than) of .333 for Mean of the raw approach/avoid novel toys score across 9 items, each with the range of 0 to 2 possible points) OR Any clear "defensive" response on orienting items or "Yes" to covering ears to sound (in stereotypies checklist)
Exclusion
- families who speak English \< 50% of the time at home
- infants with previously identified genetic disorders (e.g., Down syndrome)
- infants with identified vision/hearing/physical impairments.
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03388294
Start Date
March 8 2018
End Date
May 30 2021
Last Update
October 29 2021
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27607