Effects of PURPLE Cry Intervention

Trauma Clinical Trial

Official title:

Biological Bases of Individual Variation in Paternal Nurturance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227979
• Other study ID #: IRB00044782a
• Status: Completed
• Phase: N/A
• First received: August 26, 2014
• Last updated: April 7, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Crying
• Shaken Baby Syndrome
• Trauma

Intervention

Behavioral:
• The Purple Cry Intervention
This intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome.
• Control Intervention
This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

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