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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: Completed NA study of Autism Spectrum Disorder and Neurodevelopmental Disorders, sponsored by University of North Carolina, Chapel Hill.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in dyadic engagement (higher level supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent stud
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 |
What the finished NCT03388294 record still lists
NCT03388294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (47% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03388294's enrollment target sits among peer trials
72 106th of 224 higher than 118 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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