Abuse, ChildNCT04608877
Take 5 + Audio Clip Randomized Control Trial
A study testing Take 5 and Audio Clip and Take 5 Only in people with Abuse, Child and Crying, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Abuse, Child, Crying, Parent-Child Relations
- What is being tested?
- Take 5 and Audio Clip and Take 5 Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- parent of singleton newborn on the postpartum floor of the YNHH
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
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:
- Have higher HR/BPs and higher negative affect after the training session
- Be more likely to remember use Take 5 when they became frustrated with their infant's crying when followed up 6 weeks later.
- Be more likely to tell other people about Take 5 and be more likely to say Take 5 was useful.
Read the 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.
- Conditions
- Abuse, Child, Crying, Parent-Child Relations
- Being tested
- Take 5 and Audio Clip, Take 5 Only
- Medical subject headings
- Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take 5 and Audio ClipBehavioural
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 OnlyBehavioural
Parent will only receive the 5 discrete safety steps for infant crying
| Study group | Role | What they receive |
|---|---|---|
| Take 5 Only | Placebo comparator | Parent will only receive the 5 discrete safety steps for infant crying Receives: 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 Receives: Behavioral: Take 5 and Audio Clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of Take 5
Participants will be asked if they used Take 5
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start15 May 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse, ChildStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Bechtel, MD, Principal investigator, Professor of Pediatrics (Emergency Medicine) and of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608877
- Sponsor's protocol ID
- 2000027445
- Status last verified
- Aug 2023
- First submitted
- 17 Mar 2020
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take 5 + Audio Clip Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04608877
- Acronym / sponsor ID
- 2000027445
- Conditions
- Abuse, Child, Crying, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Have higher HR/BPs and higher negative affect after the training session
- Be more likely to remember use Take 5 when they became frustrated with their infant's crying when followed up 6 weeks later.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Take 5 Only | Placebo comparator | Behavioral: Take 5 OnlyParent will only receive the 5 discrete safety steps for infant crying |
| Take 5 and Audio Clip | Experimental | Behavioral: Take 5 and Audio ClipParent will receive the 5 discrete safety steps for infant crying and listen to the audio clip of infant crying and public service announcement message |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- parent of singleton newborn on the postpartum floor of the YNHH
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take 5 and Audio ClipParent will receive the 5 discrete safety steps for infant crying and listen to the audio clip of infant crying and public service announcement message | Behavioural | Take 5 and Audio Clip |
| Take 5 OnlyParent will only receive the 5 discrete safety steps for infant crying | Behavioural | Take 5 Only |
Primary outcome
Usage of Take 5
Time frame: 1 year
Participants will be asked if they used Take 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Bechtel, MD principal investigator
Professor of Pediatrics (Emergency Medicine) and of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take 5 and Audio Clip and Take 5 Only in people with Abuse, Child and Crying, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of Take 5 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.