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Effects of PURPLE Cry Intervention

Primary Purpose

Shaken Baby Syndrome, Crying, Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Purple Cry Intervention
Control Intervention
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Shaken Baby Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I

Group II

Arm Description

The PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review.

The control intervention group will get 1 brochure and a DVD on infant safety to review.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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)
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)
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)

Full Information

First Posted
August 26, 2014
Last Updated
April 7, 2016
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02227979
Brief Title
Effects of PURPLE Cry Intervention
Official Title
Biological Bases of Individual Variation in Paternal Nurturance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shaken Baby Syndrome, Crying, Trauma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
The PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
The control intervention group will get 1 brochure and a DVD on infant safety to review.
Intervention Type
Behavioral
Intervention Name(s)
The Purple Cry Intervention
Intervention Description
This intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome.
Intervention Type
Behavioral
Intervention Name(s)
Control Intervention
Intervention Description
This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety.
Primary Outcome Measure Information:
Title
Change in neural responses to infant cry stimuli
Description
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)
Time Frame
within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Secondary Outcome Measure Information:
Title
Change in aversiveness and in empathy
Description
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.
Time Frame
within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Title
Change in neural activity in the anterior insula and amygdala during unknown infant cry
Description
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)
Time Frame
within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Title
Change in neural activity in the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC
Description
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)
Time Frame
within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
Title
Change in neural activity in the amygdala in response to their own infant's cry stimuli
Description
The effects of the intervention will be assessed by determining changes in neural activity in the amygdala from functional magnetic resonance imaging (fMRI)
Time Frame
within one visit, pre and post PURPLE intervention, approximately 30 minutes apart

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Rilling, Ph.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Effects of PURPLE Cry Intervention

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