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NCT03480841 · ClinicalTrials.gov registry record · NA

Using the LENA System in Early Intervention - b

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT03480841: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT03480841 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03480841, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

This project will determine whether an intervention to enhance communication between infants and toddlers with developmental disabilities and their depressed mothers can be integrated into federally-funded Early Intervention (EI) services. Participants will be mothers with depressive symptoms whose children are receiving EI services, along with their EI service providers. The investigators will conduct a small feasibility trial using the Language ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring system, with 10 mothers and one of their child's EI service providers. The LENA uses an infant or toddler garment with an integrated audiotape system that records adult speech centered on the child, child vocalizations, and reciprocal parent-child turn-taking conversations. The LENA software produces visual feedback that a mother can use to focus her language interactions with her child. They study will follow participants in the LENA with feedback intervention over 6 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for 16 consecutive hours). The investigators will analyze data from measures on LENA communication data (adult word count, child vocalizations and conversational turn-taking), and measures of child language, maternal depressive symptoms, and child disability profiles.

Primary Outcome

The Language Enhancement/Intervention System (LENA), which records adult-child vocalizations, measures the number of the target adult's (e.g., parent) child-directed words (child-directed speech). The total possible range is 0-n, where higher scores indicate an increased number of child-directed words spoken by the target adult and higher degrees of a language-rich environment. Lower scores indicate fewer words spoken by the target adult and represent an environment that is not language-rich.

Interventions

  • BEHAVIORAL Language ENhancement Assessment/intervention system

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2018-04-02
Est. Completion 2018-11-04
Phase NA

What the finished NCT03480841 record still lists

NCT03480841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Language ENhancement Assessment/intervention system is the first listed.

NCT03480841 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03480841 about?

NCT03480841 is a clinical study titled "Using the LENA System in Early Intervention - b". This project will determine whether an intervention to enhance communication between infants and toddlers with developmental disabilities and their depressed mothers can be integrated into federally-funded Early Intervention (EI) services. Participants will be mothers with depressive symptoms whose ...

What is the current status of trial NCT03480841?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2018-04-02. Estimated completion is 2018-11-04.

What interventions are being tested in trial NCT03480841?

The interventions under investigation include: Language ENhancement Assessment/intervention system (BEHAVIORAL).

Who is sponsoring clinical trial NCT03480841?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03480841's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03480841, the US trial registry maintained by the National Library of Medicine. NCT03480841 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.