Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The purpose of this proposal is to determine whether adding the one-minute audio-clip of an infant crying to the Take 5 message given to parents of newborns on the postpartum floor of the hospital strengthens the preventive message. To do this, a randomized controlled trial (RCT) will be conducted. The investigators would like to determine if the anticipatory guidance of Take 5 is strengthened by hearing a 1-minute audio-clip of an infant crying followed by a preventive message about abusive head trauma, which was used as a radio public service announcement in Milwaukee, Wisconsin as part of a non-programmatic effort to reduce the rates of AHT and is used with permission. All families in the post-partum unit are eligible to have the Take 5 message as part of their anticipatory guidance before newborn hospital discharge. Randomization will be done based on the postpartum day of life. If the infant's postpartum date of life is an even number, parents will get Take 5 only; for odd numbers, they would get Take 5 and the audio PSA. For both groups, three baseline self-report measures will be obtained: the Reflective Functioning Questionnaire, the Parenting Stress Index, and the Emotion Regulation Questionnaire; and 5 measures will be obtained at baseline and after the recording: blood pressure, heart rate, and affect descriptors. Affective descriptors include the Positive and Negative Affective Scale and Likert-scales of self-reported levels of stress and frustration. After the baseline measures have been obtained, all parents will receive the current standard of care -- Take 5, the safety plan for crying. For infants born on odd days, the audio recording will be played before the parent is taught Take 5. For infants born on even days, the parent will receive Take 5. After obtaining the post-recording self-report and physiological measures, we will also ask parents using a 5-point Likert the extent to which Take 5 (both conditions), and the audio recording (odd condition only) might impact them and the caregiving practices related to their infant. About six weeks after, each parent will be contacted by phone and asked about his/her memory of the recording, how many and whom they told about the recording, and what effect if any the recording had on their self-awareness about crying and about their behaviors toward their infant. We will use a 5-point Likert scale to have parents who heard the audiotape before being taught. Take 5 describe the extent to which the recording had impacted them and their infant caregiving practices. We will also ask all parents what impact Take 5 had on their caregiving using 5-point Likert scales as well. The research protocol in the hospital should take no longer than 25 minutes. This second (telephone) interview will also be audio recorded, and then a transcript will be made for analysis. A scripted questionnaire will be used to conduct a telephone interview (see attached Interview.docx). This second interview should last approximately 10 minutes. Demographic data to be collected on the sample includes parental age, parental sex, parental ethnicity, marital status, the highest level of education (in years), number of children, age of the youngest child, age of other children (if any), number of people living in the household. We will also collect two contact phone numbers and an email address for the participant. We will also collect information on child outcomes, namely: mode of delivery, gestational age, gestational birth weight, and any complications following delivery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04608877
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date May 15, 2021
Completion date July 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT03905278 - Parental Support Intervention in the Oncological Context N/A
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04101799 - Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden N/A
Completed NCT01955551 - Motivational Interviewing to Increase Parent Engagement in Preventive Parenting Programming Phase 2
Completed NCT01432756 - A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents N/A
Recruiting NCT05706376 - An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention N/A
Recruiting NCT05930535 - Family-Focused Adolescent & Lifelong Health Promotion N/A
Completed NCT03658122 - Integrating Behavioral Treatment in Primary Care N/A
Recruiting NCT06099262 - GenPMTO Evaluation
Recruiting NCT04633434 - Evaluation Study of Talk Parenting Skills N/A
Recruiting NCT04853888 - ATTACHâ„¢ Program: Promoting Vulnerable Children's Health at Scale N/A
Recruiting NCT04627415 - Project PEAK: Early Intervention for ADHD N/A
Completed NCT04257331 - Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China N/A
Withdrawn NCT05135507 - The Effective Parenting Program (EPP) N/A
Completed NCT03853564 - Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities N/A
Active, not recruiting NCT05264415 - Intergenerational Transmission of Traumatic Stress N/A
Completed NCT04342871 - An Evaluation of the Fathers and Mothers With Cancer Communication Tool N/A
Completed NCT05117099 - Middle School Success Over Stress N/A