Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04608877 |
| Other study ID # |
2000027445 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2021 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
