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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 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants.
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.
Interventions
- BEHAVIORAL Language ENhancement Assessment/intervention system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-04-02 |
| Est. Completion | 2018-11-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03480841
The ClinicalTrials.gov registry entry for NCT03480841 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Language ENhancement Assessment/intervention system is the first listed.
NCT03480841 reports 0 study locations.
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.
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