Effects of PURPLE Cry Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biological Bases of Individual Variation in Paternal Nurturance

Conditions
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Shaken Baby Syndrome, Crying, Trauma

Intervention / Treatment
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* Behavioral: The Purple Cry Intervention
* Behavioral: Control Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>The PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review. | Behavioral: The Purple Cry Intervention<br>* This intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome.<br>|
| Active Comparator: Group II<br>The control intervention group will get 1 brochure and a DVD on infant safety to review. | Behavioral: Control Intervention<br>* This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | within one visit, pre and post PURPLE intervention, approximately 30 minutes apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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) | 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) | within one visit, pre and post PURPLE intervention, approximately 30 minutes apart |