Shaken Baby SyndromeNCT02227979
Effects of PURPLE Cry Intervention
A study testing The Purple Cry Intervention in people with Shaken Baby Syndrome and Crying, run by Emory University at 1 site in United States.
Trial summary
The proposed study is designed to investigate whether the PURPLE Crying program attains efficacy by optimizing the neural response in the anterior insula, and augmenting activity in regions of the brain known to be important for emotion regulation. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Shaken Baby Syndrome, Crying, Trauma
- What is being tested?
- The Purple Cry Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2016
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- biological fathers of children age 2 months or younger who are currently cohabitating with the child's mother
- fathers with normal or corrected-to-normal (with contact lenses) vision
Who cannot join
- history of head trauma, seizures or other neurological disorder
- psychiatric illness
- alcoholism or any other substance abuse
- serious medical illness
- claustrophobia
- ferrous metal in any part of body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biological Bases of Individual Variation in Paternal Nurturance
The proposed study is designed to investigate whether the PURPLE Crying program attains efficacy by optimizing the neural response in the anterior insula, and augmenting activity in regions of the brain known to be important for emotion regulation.
The aim is to determine the effects of the PURPLE Cry Intervention by investigating the following:
Read more
- independent variables that may affect a father's neural response to infant cries
- effects of the PURPLE cry intervention, compared to a control intervention, on fathers' reported aversiveness and empathy in response to cry stimuli
- effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural response to unknown infant cries compared to a tone control
- effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural responses to own infant cries compared to unknown infant cries
The investigators hypothesize:
- prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be modulated by the following variables: subjective self-reported emotional reaction to cry stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant temperament, life stressors, parental expectations, personality (neuroticism), and father's own childhood experience
- fathers who receive the PURPLE material compared to those that receive the control intervention will report a larger decrease in aversiveness and a larger increase in empathy in response to cry stimuli
- fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger decrease in activity in the anterior insula and amygdala in response to cry stimuli
- fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger increase in activity in regions of the brain important for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC
- fathers' neural activity in the amygdala in response to their own infant's cry stimuli will be positively correlated with both their own and infant testosterone levels
Read the detailed description
40 biological fathers of children age 2 months or younger who are currently cohabitating with the child's mother will be scanned on two separate occasions. The optional second visit will occur after 2 months have passed since the first scan. In the first visit, fathers will receive two MRI scans, one before and one after completing one of the two interventions. Prior to the MRI scan, a blood sample will be collected for measurement of hormone levels. Fathers will be positioned in the MRI scanner where they will receive structural and functional MRI scans of their brain while they listen to auditory stimuli: unknown cries, own cries, and tone controls. Blood sample collection and intervention will not be conducted during the second visit.
- Conditions
- Shaken Baby Syndrome, Crying, Trauma
- Being tested
- The Purple Cry Intervention, Control Intervention
- Medical subject headings
- Shaken Baby Syndrome, Crying, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Purple Cry InterventionBehavioural
This intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome.
Control InterventionBehavioural
This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | The PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review. Receives: Behavioral: The Purple Cry Intervention |
| Group II | Active comparator | The control intervention group will get 1 brochure and a DVD on infant safety to review. Receives: Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neural responses to infant cry stimuli
The effects of the intervention will be assessed by determining changes in neural responses between PURPLE Cry and Brochures treatments from functional magnetic resonance imaging (fMRI)
Measured: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Secondary outcomes (4)
Change in aversiveness and in empathy
The effects of the intervention will be assessed by determining changes in aversiveness and in empathy between PURPLE Cry and Brochures treatments by using Davis's Interpersonal Reactivity Index (IRI) and Beck Depression Inventory.
Measured: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Change in neural activity in the anterior insula and amygdala during unknown infant cry
The effects of the intervention will be assessed by determining changes in activity in the anterior insula and amygdala between PURPLE Cry and Brochures treatments from functional magnetic resonance imaging (fMRI)
Measured: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Change in neural activity in the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC
The effects of the intervention will be assessed by determining changes in activity in regions of the brain important for emotion regulation between PURPLE Cry and Brochures treatments from functional magnetic resonance imaging (fMRI)
Measured: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Change in neural activity in the amygdala in response to their own infant's cry stimuli
The effects of the intervention will be assessed by determining changes in neural activity in the amygdala from functional magnetic resonance imaging (fMRI)
Measured: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shaken Baby SyndromeStudies of the same condition, open and under way.
- More trials run by Emory 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James K. Rilling, PhD, Emory University
- Investigators
- James K Rilling, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227979
- Sponsor's protocol ID
- IRB00044782a
- Status last verified
- Apr 2016
- First submitted
- 26 Aug 2014
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Bases of Individual Variation in Paternal Nurturance
- ClinicalTrials.gov ID
- NCT02227979
- Acronym / sponsor ID
- IRB00044782a
- Conditions
- Shaken Baby Syndrome, Crying, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Aug 2014 (estimated)
- 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.
The proposed study is designed to investigate whether the PURPLE Crying program attains efficacy by optimizing the neural response in the anterior insula, and augmenting activity in regions of the brain known to be important for emotion regulation.
The aim is to determine the effects of the PURPLE Cry Intervention by investigating the following:
- independent variables that may affect a father's neural response to infant cries
- effects of the PURPLE cry intervention, compared to a control intervention, on fathers' reported aversiveness and empathy in response to cry stimuli
- effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural response to unknown infant cries compared to a tone control
- effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural responses to own infant cries compared to unknown infant cries
The investigators hypothesize:
- prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be modulated by the following variables: subjective self-reported emotional reaction to cry stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant temperament, life stressors, parental expectations, personality (neuroticism), and father's own childhood experience
- fathers who receive the PURPLE material compared to those that receive the control intervention will report a larger decrease in aversiveness and a larger increase in empathy in response to cry stimuli
- fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger decrease in activity in the anterior insula and amygdala in response to cry stimuli
- fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger increase in activity in regions of the brain important for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC
- fathers' neural activity in the amygdala in response to their own infant's cry stimuli will be positively correlated with both their own and infant testosterone levels
Detailed description
40 biological fathers of children age 2 months or younger who are currently cohabitating with the child's mother will be scanned on two separate occasions. The optional second visit will occur after 2 months have passed since the first scan. In the first visit, fathers will receive two MRI scans, one before and one after completing one of the two interventions. Prior to the MRI scan, a blood sample will be collected for measurement of hormone levels. Fathers will be positioned in the MRI scanner where they will receive structural and functional MRI scans of their brain while they listen to auditory stimuli: unknown cries, own cries, and tone controls. Blood sample collection and intervention will not be conducted during the second visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Behavioral: The Purple Cry InterventionThe PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review. |
| Group II | Active comparator | Behavioral: Control InterventionThe control intervention group will get 1 brochure and a DVD on infant safety to review. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- biological fathers of children age 2 months or younger who are currently cohabitating with the child's mother
- fathers with normal or corrected-to-normal (with contact lenses) vision
Key exclusion criteria (6 listed)
- history of head trauma, seizures or other neurological disorder
- psychiatric illness
- alcoholism or any other substance abuse
- serious medical illness
- claustrophobia
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 |
|---|---|---|
| The Purple Cry InterventionThis intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome. | Behavioural | Group I |
| Control InterventionThis intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety. | Behavioural | Group II |
Primary outcome
Change in neural responses to infant cry stimuli
Time frame: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
The effects of the intervention will be assessed by determining changes in neural responses between PURPLE Cry and Brochures treatments from functional magnetic resonance imaging (fMRI)
4 secondary outcomes
Change in aversiveness and in empathy
Time frame: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Change in neural activity in the anterior insula and amygdala during unknown infant cry
Time frame: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Change in neural activity in the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC
Time frame: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Change in neural activity in the amygdala in response to their own infant's cry stimuli
Time frame: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
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 8 Apr 2016.
Related trials for Shaken Baby Syndrome
Not yet recruiting
The Impact of the Nurse-Led "My Baby is Safe" Educational Program
Sudden Infant Death Syndrome, Shaken Baby Syndrome
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.
James K Rilling, Ph.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Purple Cry Intervention in people with Shaken Baby Syndrome and Crying, run by Emory 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 2 inclusion and 6 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 8 Apr 2016. 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. 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?
Change in neural responses to infant cry stimuli (time frame: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart). 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 8 Apr 2016.