<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/NCT04454645</url>
  </required_header>
  <id_info>
    <org_study_id>mABC</org_study_id>
    <secondary_id>1R01HD098525-01A1</secondary_id>
    <nct_id>NCT04454645</nct_id>
  </id_info>
  <brief_title>Intervening With Opioid-Dependent MothersMothers and Infants</brief_title>
  <acronym>mABC</acronym>
  <official_title>Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Delaware</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up&#xD;
      (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted&#xD;
      treatment for opioid use disorder. The investigators expect that mothers who receive the&#xD;
      modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and&#xD;
      sensitive parenting and more adaptive physiological regulation than parents who receive a&#xD;
      control intervention. The investigators expect that infants whose mothers receive the&#xD;
      modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment,&#xD;
      behavior, and physiological regulation than infants of parents who receive the control&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnant mothers will be randomly assigned to receive the modified ABC intervention or the&#xD;
      control intervention (modified DEF). Hypotheses relate to parent and child outcomes&#xD;
      associated with the intervention. Hypothesis 1: Compared to mothers who receive the control&#xD;
      intervention, mothers who receive the mABC intervention will show more nurturing and&#xD;
      sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more&#xD;
      normative patterns of DNA methylation, autonomic nervous system activity, and cortisol&#xD;
      production. Hypothesis 2: Compared to infants of mothers who receive the control&#xD;
      intervention, infants of mothers who receive the mABC intervention will show more organized&#xD;
      and secure attachment patterns, better behavioral regulation during stressors, more advanced&#xD;
      social-emotional development, and more normative patterns of DNA methylation, autonomic&#xD;
      nervous system activity, and cortisol production. Hypothesis 3: Enhanced maternal sensitivity&#xD;
      will mediate effects of the mABC intervention on improved infant outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal sensitivity</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>The mother will be assessed interacting with the infant simulator. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal sensitivity</measure>
    <time_frame>Infant age of 3 months</time_frame>
    <description>The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal sensitivity</measure>
    <time_frame>Infant age of 6 months</time_frame>
    <description>The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal sensitivity</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal methylation of μ-opioid receptor (OPRM1) gene</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal methylation of μ-opioid receptor (OPRM1) gene</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal methylation of oxytocin receptor (OXTR) gene</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal methylation of oxytocin receptor (OXTR) gene</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant methylation of μ-opioid receptor (OPRM1) gene</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant methylation of μ-opioid receptor (OPRM1) gene</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal neural activity (Event related potentials - ERP) - Own child-other child task</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Maternal event-related potentials (ERP) will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal neural activity (Event related potentials - ERP) - Own child-other child task</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Maternal event-related potentials will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal neural activity (Event related potentials - ERP) - Child emotion task</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal neural activity (Event related potentials - ERP) - Child emotion task</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal parasympathetic nervous system activity during Still Face</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal parasympathetic nervous system activity</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant parasympathetic nervous system activity</measure>
    <time_frame>Infant age of 6 months</time_frame>
    <description>The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant parasympathetic nervous system activity</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant diurnal cortisol production</measure>
    <time_frame>Infant age of 6 months</time_frame>
    <description>Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant diurnal cortisol production</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant behavioral regulation</measure>
    <time_frame>Infant age of 6 months</time_frame>
    <description>Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant behavioral regulation</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant attachment</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Infant attachment will be assessed using the Strange Situation. Coding will be completed using the standard Strange Situation coding scheme (with 4 major categories, with secure preferable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant cognitive development</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. Scores could range from 0-300 with higher scores reflecting higher functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal substance use</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal substance use</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal depression</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal depression</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal executive functioning</measure>
    <time_frame>Pre-intervention (3rd trimester)</time_frame>
    <description>Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal executive functioning</measure>
    <time_frame>Infant age of 12 months</time_frame>
    <description>Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Opioid Dependence</condition>
  <condition>Parenting</condition>
  <condition>Infant Development</condition>
  <arm_group>
    <arm_group_label>Modified ABC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified DEF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mABC</intervention_name>
    <description>Intervention targets parenting sensitivity and nurturance.</description>
    <arm_group_label>Modified ABC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mDEF</intervention_name>
    <description>Intervention targets parenting enhancing infant cognitive development</description>
    <arm_group_label>Modified DEF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted&#xD;
             treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Dozier, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Delaware</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mary Dozier, Ph.D.</last_name>
    <phone>3028312286</phone>
    <email>mdozier@udel.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19716</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mary Dozier, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>April 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Delaware</investigator_affiliation>
    <investigator_full_name>Mary Dozier</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</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/NCT04454645
org study id: mABC
secondary id: 1R01HD098525-01A1
nct id: NCT04454645
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up
      (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted
      treatment for opioid use disorder. The investigators expect that mothers who receive the
      modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and
      sensitive parenting and more adaptive physiological regulation than parents who receive a
      control intervention. The investigators expect that infants whose mothers receive the
      modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment,
      behavior, and physiological regulation than infants of parents who receive the control
      intervention.
Pregnant mothers will be randomly assigned to receive the modified ABC intervention or the
      control intervention (modified DEF). Hypotheses relate to parent and child outcomes
      associated with the intervention. Hypothesis 1: Compared to mothers who receive the control
      intervention, mothers who receive the mABC intervention will show more nurturing and
      sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more
      normative patterns of DNA methylation, autonomic nervous system activity, and cortisol
      production. Hypothesis 2: Compared to infants of mothers who receive the control
      intervention, infants of mothers who receive the mABC intervention will show more organized
      and secure attachment patterns, better behavioral regulation during stressors, more advanced
      social-emotional development, and more normative patterns of DNA methylation, autonomic
      nervous system activity, and cortisol production. Hypothesis 3: Enhanced maternal sensitivity
      will mediate effects of the mABC intervention on improved infant outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Maternal sensitivity
time frame: Pre-intervention (3rd trimester)
description: The mother will be assessed interacting with the infant simulator. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
measure: Maternal sensitivity
time frame: Infant age of 3 months
description: The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
measure: Maternal sensitivity
time frame: Infant age of 6 months
description: The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
measure: Maternal sensitivity
time frame: Infant age of 12 months
description: The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
measure: Maternal methylation of μ-opioid receptor (OPRM1) gene
time frame: Pre-intervention (3rd trimester)
description: Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
measure: Maternal methylation of μ-opioid receptor (OPRM1) gene
time frame: Infant age of 12 months
description: Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
measure: Maternal methylation of oxytocin receptor (OXTR) gene
time frame: Pre-intervention (3rd trimester)
description: Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
measure: Maternal methylation of oxytocin receptor (OXTR) gene
time frame: Infant age of 12 months
description: Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
measure: Infant methylation of μ-opioid receptor (OPRM1) gene
time frame: Pre-intervention (3rd trimester)
description: Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
measure: Infant methylation of μ-opioid receptor (OPRM1) gene
time frame: Infant age of 12 months
description: Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
measure: Maternal neural activity (Event related potentials - ERP) - Own child-other child task
time frame: Pre-intervention (3rd trimester)
description: Maternal event-related potentials (ERP) will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.
measure: Maternal neural activity (Event related potentials - ERP) - Own child-other child task
time frame: Infant age of 12 months
description: Maternal event-related potentials will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.
measure: Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
time frame: Pre-intervention (3rd trimester)
description: Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.
measure: Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
time frame: Infant age of 12 months
description: Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.
measure: Maternal neural activity (Event related potentials - ERP) - Child emotion task
time frame: Pre-intervention (3rd trimester)
description: Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.
measure: Maternal neural activity (Event related potentials - ERP) - Child emotion task
time frame: Infant age of 12 months
description: Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.
measure: Maternal parasympathetic nervous system activity during Still Face
time frame: Pre-intervention (3rd trimester)
description: The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
measure: Maternal parasympathetic nervous system activity
time frame: Infant age of 12 months
description: The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
measure: Infant parasympathetic nervous system activity
time frame: Infant age of 6 months
description: The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
measure: Infant parasympathetic nervous system activity
time frame: Infant age of 12 months
description: The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
measure: Infant diurnal cortisol production
time frame: Infant age of 6 months
description: Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
measure: Infant diurnal cortisol production
time frame: Infant age of 12 months
description: Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
measure: Infant behavioral regulation
time frame: Infant age of 6 months
description: Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).
measure: Infant behavioral regulation
time frame: Infant age of 12 months
description: Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).
measure: Infant attachment
time frame: Infant age of 12 months
description: Infant attachment will be assessed using the Strange Situation. Coding will be completed using the standard Strange Situation coding scheme (with 4 major categories, with secure preferable).
measure: Infant cognitive development
time frame: Infant age of 12 months
description: Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. Scores could range from 0-300 with higher scores reflecting higher functioning.
measure: Maternal substance use
time frame: Pre-intervention (3rd trimester)
description: Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited).
measure: Maternal substance use
time frame: Infant age of 12 months
description: Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited).
measure: Maternal depression
time frame: Pre-intervention (3rd trimester)
description: Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.)
measure: Maternal depression
time frame: Infant age of 12 months
description: Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.)
measure: Maternal executive functioning
time frame: Pre-intervention (3rd trimester)
description: Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.
measure: Maternal executive functioning
time frame: Infant age of 12 months
description: Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.
arm group label: Modified ABC
arm group type: Experimental
description: 12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
arm group label: Modified DEF
arm group type: Active Comparator
description: 12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development
intervention type: Behavioral
intervention name: mABC
description: Intervention targets parenting sensitivity and nurturance.
arm group label: Modified ABC
intervention type: Behavioral
intervention name: mDEF
description: Intervention targets parenting enhancing infant cognitive development
arm group label: Modified DEF
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mary Dozier, Ph.D.
role: Principal Investigator
affiliation: University of Delaware
last name: Mary Dozier, Ph.D.
phone: 3028312286
email: mdozier@udel.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Delaware
investigator full name: Mary Dozier
investigator title: Professor
mesh term: Opioid-Related Disorders