Take 5 + Audio Clip Randomized Control Trial
Condition: Abuse, Child; Crying; Parent-Child Relations
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Take 5 and Audio Clip; Take 5 Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; Parent will only receive the 5 discrete safety steps for infant crying
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention