Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02227979
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2014-08-26
Brief Title:
Effects of PURPLE Cry Intervention
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Biological Bases of Individual Variation in Paternal Nurturance
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
The aim is to determine the effects of the PURPLE Cry Intervention by investigating the following
independent variables that may affect a fathers 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 fathers 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 infants cry stimuli will be positively correlated with both their own and infant testosterone levels
The aim is to determine the effects of the PURPLE Cry Intervention by investigating the following
independent variables that may affect a fathers 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 fathers 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 infants 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None