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NCT03388294 · ClinicalTrials.gov registry record · NA
Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders
A NA study of Autism Spectrum Disorder and Neurodevelopmental Disorders, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT03388294 is a NA study of Autism Spectrum Disorder and Neurodevelopmental Disorders that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 72 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03388294, a NA study of Autism Spectrum Disorder and Neurodevelopmental Disorders, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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 the current study are to examine whether the PIE intervention (a) transforms parent-infant transactions over time as intended, thereby facilitating increases in the time infants spend in joint engagement with their parents, and (b) is associated with improved social-communication functioning and positive changes in indices of autonomic self-regulation in infants at-risk for NDs.
Conditions Studied
Interventions
- BEHAVIORAL Parents and Infants Engaged
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-03-08 |
| Est. Completion | 2021-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03388294
The ClinicalTrials.gov registry entry for NCT03388294 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (47% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Parents and Infants Engaged is the first listed.
NCT03388294 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03388294 about?
NCT03388294 is a clinical study titled "Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders". 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 the current study are to examine whether the PIE intervention (a) transforms parent-infant transactio...
What is the current status of trial NCT03388294?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2018-03-08. Estimated completion is 2021-05-30.
What conditions does trial NCT03388294 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Neurodevelopmental Disorders.
What interventions are being tested in trial NCT03388294?
The interventions under investigation include: Parents and Infants Engaged (BEHAVIORAL).
Who is sponsoring clinical trial NCT03388294?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03388294 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.