CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Parents and Infants Engagedbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03388294
NCT03388294N/ACompleted

Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders

University of North Carolina, Chapel Hill·interventional·Posted Jan 2, 2018·Updated Oct 29, 2021

In Brief

A clinical study evaluating Parents and Infants Engaged for Autism Spectrum Disorder and Neurodevelopmental Disorders. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 2, 2018
Enrollment StartMar 8, 2018
Primary CompletionApr 1, 2020
Study CompletionMay 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.5 years ago

Interventions

Parents and Infants Engagedbehavioral

A novel in-home parent coaching intervention addressing transactions between pre-linguistic communication and sensory reactivity in infants at-risk for autism and other NDs on the one hand, and parent responses to infant cues on the other hand, using live coaching and video feedback methods.