Skip to main content
OpenTrials
Completed

NCT Number: NCT02227979

Effects of PURPLE Cry Intervention

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shaken Baby Syndrome Behavior Brain Injuries Communication Craniocerebral Trauma Crying Nervous System Diseases Nonverbal Communication Trauma Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control Intervention

Behavioral

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

Primary outcomes

  1. Change in neural responses to infant cry stimuli

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

    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 outcomes

  1. Change in aversiveness and in empathy

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

    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.

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

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

    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)

  3. Change in neural activity in the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC

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

    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)

  4. Change in neural activity in the amygdala in response to their own infant's cry stimuli

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

    The effects of the intervention will be assessed by determining changes in neural activity in the amygdala from functional magnetic resonance imaging (fMRI)

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Biological Bases of Individual Variation in Paternal Nurturance

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2014
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.