Using the LENA System in Early Intervention

NCT03164642 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-02-28

No results posted yet for this 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 randomized control trial using the Language ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring system, with 20 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. A "LENA with feedback" group will follow participants in the intervention over 5 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for 16 consecutive hours), with feedback during 3 weeks (baseline=LENA, no feedback; 3 week intervention=LENA with feedback; post-intervention=LENA, no feedback). A "LENA no feedback" group will complete LENA data collection at baseline on the same schedule but will not receive feedback. The main difference between groups will be provision of LENA feedback and strategies to promote increased mother-child interactions. This design allows the investigators to isolate the effect of LENA with feedback, and minimizes attributing changes in language environments due to exposure to LENA alone. 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.

Conditions

  • Depression

Interventions

BEHAVIORAL

LENA with Feedback

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. During their regular EI providers will use a standardized feedback protocol that includes emphasizing the mother's strengths, reviewing the LENA visual output from the previous recording, and asking questions to elicit how the mother can increase her child-centered and reciprocal communications during daily routines. The conversation will include concrete examples of how the mother can increase the language exchanges, encouragement, and practical ways to individually tailor the strategies to the family.

BEHAVIORAL

LENA no feedback

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Linda Beeber, PhD · University of North Carolina, Chapel Hill

  • Anne Wheeler, PhD · RTI International

  • Doré LaForett, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03164642 on ClinicalTrials.gov