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NCT04031326 · ClinicalTrials.gov registry record · NA
Randomized Trial of LENA Home in A Home Visiting Program
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT04031326: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04031326 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04031326, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study evaluates feasibility and efficacy of adding the LENA Home program to the standard Every Child Succeeds (ECS) home visiting curriculum. Half of the participants will receive the standard ECS curriculum during normally scheduled home visits, while the other half will receive this plus LENA Home.
Primary Outcome
The LENA Home recording device measures Absolute Word Count (AWC) over an approximately 13-hour recording period at each recording. This outcome will involve change in AWC between baseline and a Midpoint assessment (approximately 6-7 weeks) and Endpoint (13-weeks).
Interventions
- BEHAVIORAL LENA Home
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2020-02-01 |
| Phase | NA |
What the finished NCT04031326 record still lists
NCT04031326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which LENA Home is the first listed.
NCT04031326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04031326 about?
NCT04031326 is a clinical study titled "Randomized Trial of LENA Home in A Home Visiting Program". This study evaluates feasibility and efficacy of adding the LENA Home program to the standard Every Child Succeeds (ECS) home visiting curriculum. Half of the participants will receive the standard ECS curriculum during normally scheduled home visits, while the other half will receive this plus LENA...
What is the current status of trial NCT04031326?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2019-04-01. Estimated completion is 2020-02-01.
What interventions are being tested in trial NCT04031326?
The interventions under investigation include: LENA Home (BEHAVIORAL).
Who is sponsoring clinical trial NCT04031326?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04031326's enrollment target sits among peer trials
31 1592nd of 2000 higher than 408 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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