Take 5 + Audio Clip Randomized Control Trial

NCT04608877 | Completed

• 1 other identifier: 2000027445
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. 1.Have higher HR/BPs and higher negative affect after the training session
2. 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. 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

Outcome Measures

Primary Outcomes (1)

• Usage of Take 5

  Participants will be asked if they used Take 5

  1 year

Study Arms (2)

Take 5 Only

PLACEBO COMPARATOR

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

Behavioral: Take 5 Only

Take 5 and Audio Clip

EXPERIMENTAL

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 and Audio Clip

Interventions

Take 5 and Audio Clip BEHAVIORAL

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

Take 5 and Audio Clip

Take 5 Only BEHAVIORAL

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

Take 5 Only

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- parent of singleton newborn on the postpartum floor of the YNHH

You may not qualify if:

• presence of severe psychiatric or substance-related symptoms requiring in-patient psychiatric hospitalization or ambulatory detoxification
• persons incapable of giving informed consent
• insufficient English fluency
• maternal medical complication from delivery (e.g eclampsia, postpartum hemorrhage or infection)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Crying

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Study Officials

• Kirsten Bechtel, MD

  Professor of Pediatrics (Emergency Medicine) and of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: October 29, 2020
• Study Start: May 15, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: August 2023

Locations

US (1)