<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02227979</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00044782a</org_study_id>
    <nct_id>NCT02227979</nct_id>
  </id_info>
  <brief_title>Effects of PURPLE Cry Intervention</brief_title>
  <official_title>Biological Bases of Individual Variation in Paternal Nurturance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is designed to investigate whether the PURPLE Crying program attains&#xD;
      efficacy by optimizing the neural response in the anterior insula, and augmenting activity in&#xD;
      regions of the brain known to be important for emotion regulation.&#xD;
&#xD;
      The aim is to determine the effects of the PURPLE Cry Intervention by investigating the&#xD;
      following:&#xD;
&#xD;
        -  independent variables that may affect a father's neural response to infant cries&#xD;
&#xD;
        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'&#xD;
           reported aversiveness and empathy in response to cry stimuli&#xD;
&#xD;
        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'&#xD;
           neural response to unknown infant cries compared to a tone control&#xD;
&#xD;
        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'&#xD;
           neural responses to own infant cries compared to unknown infant cries&#xD;
&#xD;
      The investigators hypothesize:&#xD;
&#xD;
        -  prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be&#xD;
           modulated by the following variables: subjective self-reported emotional reaction to cry&#xD;
           stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant&#xD;
           temperament, life stressors, parental expectations, personality (neuroticism), and&#xD;
           father's own childhood experience&#xD;
&#xD;
        -  fathers who receive the PURPLE material compared to those that receive the control&#xD;
           intervention will report a larger decrease in aversiveness and a larger increase in&#xD;
           empathy in response to cry stimuli&#xD;
&#xD;
        -  fathers who receive the PURPLE material compared to those that receive the control&#xD;
           intervention will show a larger decrease in activity in the anterior insula and amygdala&#xD;
           in response to cry stimuli&#xD;
&#xD;
        -  fathers who receive the PURPLE material compared to those that receive the control&#xD;
           intervention will show a larger increase in activity in regions of the brain important&#xD;
           for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and&#xD;
           orbitofrontal PFC&#xD;
&#xD;
        -  fathers' neural activity in the amygdala in response to their own infant's cry stimuli&#xD;
           will be positively correlated with both their own and infant testosterone levels&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      40 biological fathers of children age 2 months or younger who are currently cohabitating with&#xD;
      the child's mother will be scanned on two separate occasions. The optional second visit will&#xD;
      occur after 2 months have passed since the first scan. In the first visit, fathers will&#xD;
      receive two MRI scans, one before and one after completing one of the two interventions.&#xD;
      Prior to the MRI scan, a blood sample will be collected for measurement of hormone levels.&#xD;
      Fathers will be positioned in the MRI scanner where they will receive structural and&#xD;
      functional MRI scans of their brain while they listen to auditory stimuli: unknown cries, own&#xD;
      cries, and tone controls. Blood sample collection and intervention will not be conducted&#xD;
      during the second visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in neural responses to infant cry stimuli</measure>
    <time_frame>within one visit, pre and post PURPLE intervention, approximately 30 minutes apart</time_frame>
    <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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in aversiveness and in empathy</measure>
    <time_frame>within one visit, pre and post PURPLE intervention, approximately 30 minutes apart</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in neural activity in the anterior insula and amygdala during unknown infant cry</measure>
    <time_frame>within one visit, pre and post PURPLE intervention, approximately 30 minutes apart</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in neural activity in the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC</measure>
    <time_frame>within one visit, pre and post PURPLE intervention, approximately 30 minutes apart</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in neural activity in the amygdala in response to their own infant's cry stimuli</measure>
    <time_frame>within one visit, pre and post PURPLE intervention, approximately 30 minutes apart</time_frame>
    <description>The effects of the intervention will be assessed by determining changes in neural activity in the amygdala from functional magnetic resonance imaging (fMRI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Shaken Baby Syndrome</condition>
  <condition>Crying</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control intervention group will get 1 brochure and a DVD on infant safety to review.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Purple Cry Intervention</intervention_name>
    <description>This intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome.</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Intervention</intervention_name>
    <description>This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety.</description>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  biological fathers of children age 2 months or younger who are currently cohabitating&#xD;
             with the child's mother&#xD;
&#xD;
          -  fathers with normal or corrected-to-normal (with contact lenses) vision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of head trauma, seizures or other neurological disorder&#xD;
&#xD;
          -  psychiatric illness&#xD;
&#xD;
          -  alcoholism or any other substance abuse&#xD;
&#xD;
          -  serious medical illness&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  ferrous metal in any part of body&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James K Rilling, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>April 7, 2016</last_update_submitted>
  <last_update_submitted_qc>April 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>James K. Rilling, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shaken Baby Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02227979
org study id: IRB00044782a
nct id: NCT02227979
lead sponsor: 
has dmc: Yes
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
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in neural responses to infant cry stimuli
time frame: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
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)
measure: Change in aversiveness and in empathy
time frame: within one visit, pre and post PURPLE intervention, approximately 30 minutes apart
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.
measure: 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
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)
measure: 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
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)
measure: 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
description: The effects of the intervention will be assessed by determining changes in neural activity in the amygdala from functional magnetic resonance imaging (fMRI)
arm group label: Group I
arm group type: Experimental
description: The PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review.
arm group label: Group II
arm group type: Active Comparator
description: The control intervention group will get 1 brochure and a DVD on infant safety to review.
intervention type: Behavioral
intervention name: The Purple Cry Intervention
description: This intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome.
arm group label: Group I
intervention type: Behavioral
intervention name: Control Intervention
description: This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety.
arm group label: Group II
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James K Rilling, Ph.D.
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: James K. Rilling, PhD
investigator title: Associate Professor
mesh term: Shaken Baby Syndrome