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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: Completed NA study of Parent-Child Relations and Abuse, Child, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants will be asked if they used Take 5
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 |
What the finished NCT04608877 record still lists
NCT04608877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 319-participant average among 38 other Parent-Child Relations trials with a reported enrollment target (76% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04608877's enrollment target sits among peer trials
76 30th of 38 higher than 9 of 38 other Parent-Child Relations trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parent-Child Relations 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.
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