CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Language ENhancement Assessment/intervention systembehavioral
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/NCT03480841
NCT03480841N/ACompleted

Enhancing Communication Between Children in EI and Their Depressed Mothers

University of North Carolina, Chapel Hill·interventional·Posted Mar 29, 2018·Updated Dec 19, 2019

In Brief

A clinical study evaluating Language ENhancement Assessment/intervention system for Depression. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 29, 2018
Enrollment StartApr 2, 2018
Primary CompletionNov 4, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.3 years ago

Interventions

Language ENhancement Assessment/intervention systembehavioral

The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.