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NCT04608877 · ClinicalTrials.gov registry record · NA
Take 5 + Audio Clip Randomized Control Trial
A NA study of Parent-Child Relations and Abuse, Child, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT04608877 is a NA study of Parent-Child Relations and Abuse, Child that has completed, run by Yale University. The registered enrollment target is 76 participants, below the 319-participant average among 38 other Parent-Child Relations trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04608877, a NA study of Parent-Child Relations and Abuse, Child, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
Study Summary
At Yale New Haven Hospital, parents on the postpartum ward receive a Take 5 program to help train and prepare parents for strategies to manage their infant's crying. Inconsolable crying is a leading cause for abusive head trauma (AHT) in infants, and the Take 5 program has proven effective in reducing rates of AHT. However, it is also important to examine new ways of improving AHT preventative programs to optimize outcomes for infants. The purpose of this proposal is to determine whether adding a one-minute audio-clip of an infant crying, which specifically addresses AHT, to the Take 5 message given to parents of newborns on the postpartum floor of the hospital strengthens the preventive message. This is a randomized controlled trial (RCT) of parents on the postpartum ward; half will receive just Take 5, and the other half will receive the audio-clip and Take 5. Our hypotheses to be tested are that relative to parents who had Take 5 alone, those parents who hear the audio-clip before learning Take 5 will: 1. Have higher HR/BPs and higher negative affect after the training session 2. Be more likely to remember use Take 5 when they became frustrated with their infant's crying when followed up 6 weeks later. 3. Be more likely to tell other people about Take 5 and be more likely to say Take 5 was useful.
Conditions Studied
Interventions
- BEHAVIORAL Take 5 and Audio Clip
- BEHAVIORAL Take 5 Only
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-05-15 |
| Est. Completion | 2023-07-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04608877
The ClinicalTrials.gov registry entry for NCT04608877 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 319-participant average among 38 other Parent-Child Relations trials with a reported enrollment target (76% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Parent-Child Relations appearing as the primary indexed condition, and to 2 interventions - of which Take 5 and Audio Clip is the first listed.
NCT04608877 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT04608877 about?
NCT04608877 is a clinical study titled "Take 5 + Audio Clip Randomized Control Trial". At Yale New Haven Hospital, parents on the postpartum ward receive a Take 5 program to help train and prepare parents for strategies to manage their infant's crying. Inconsolable crying is a leading cause for abusive head trauma (AHT) in infants, and the Take 5 program has proven effective in reduci...
What is the current status of trial NCT04608877?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2021-05-15. Estimated completion is 2023-07-01.
What conditions does trial NCT04608877 study?
This clinical trial studies the following conditions: Parent-Child Relations, Abuse, Child, Crying.
What interventions are being tested in trial NCT04608877?
The interventions under investigation include: Take 5 and Audio Clip (BEHAVIORAL), Take 5 Only (BEHAVIORAL).
Who is sponsoring clinical trial NCT04608877?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04608877 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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