Trauma Clinical Trial
Official title:
Biological Bases of Individual Variation in Paternal Nurturance
Verified date | April 2016 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 42 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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