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Take 5 + Audio Clip Randomized Control Trial

NCT04608877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-08-07

No results posted yet for this 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

  • Abuse, Child
  • Crying
  • Parent-Child Relations

Interventions

BEHAVIORAL

Take 5 and Audio Clip

Parent will receive the 5 discrete safety steps for infant crying and listen to the audio clip of infant crying and public service announcement message

BEHAVIORAL

Take 5 Only

Parent will only receive the 5 discrete safety steps for infant crying

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Kirsten Bechtel, MD · Professor of Pediatrics (Emergency Medicine) and of Emergency Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2023-07-01
Completion
2023-07-01

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 NCT04608877 on ClinicalTrials.gov