Effects of PURPLE Cry Intervention

NCT02227979 | Completed DMC

• 1 other identifier: IRB00044782a
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Shaken Baby Syndrome; Crying; Trauma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in aversiveness and in empathy

  within one visit, pre and post PURPLE intervention, approximately 30 minutes apart

• Change in neural activity in the anterior insula and amygdala during unknown infant cry

  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

  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

  within one visit, pre and post PURPLE intervention, approximately 30 minutes apart

Study Arms (2)

Group I

EXPERIMENTAL

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

Behavioral: The Purple Cry Intervention

Group II

ACTIVE COMPARATOR

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

Behavioral: Control Intervention

Interventions

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.

Group I

Control Intervention BEHAVIORAL

This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety.

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Shaken Baby Syndrome; Crying; Wounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Nonverbal Communication; Communication; Behavior

Study Officials

• James K Rilling, Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: September 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

US (1)