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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:
The investigators hypothesize:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | The PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review. |
|
| Group II | Active Comparator | The control intervention group will get 1 brochure and a DVD on infant safety to review. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Purple Cry Intervention | Behavioral | This intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James K Rilling, Ph.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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| ID | Term |
|---|---|
| D038642 | Shaken Baby Syndrome |
| D003448 | Crying |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
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| Control Intervention | Behavioral | This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety. |
|
| 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 |
| D009633 |
| Nonverbal Communication |
| D003142 | Communication |
| D001519 | Behavior |