<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/NCT04441307</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003112</org_study_id>
    <secondary_id>7R01AA027708-02</secondary_id>
    <secondary_id>SITE00000607,</secondary_id>
    <nct_id>NCT04441307</nct_id>
  </id_info>
  <brief_title>Promoting Co-Parenting and Reducing Hazardous Drinking in New Families</brief_title>
  <official_title>Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rochester Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Penn State University</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 aims to understand if a parenting program that helps couples learn to parent as a&#xD;
      team and maintain a healthy lifestyle, such as maintaining safer levels of alcohol use,&#xD;
      promotes parent and child health and well-being. Programs will be delivered prenatally and&#xD;
      postnatally and will include both group classes and individualized sessions. A comprehensive&#xD;
      assessment is administered during pregnancy and then at 6 and 12 months of child age. It is&#xD;
      hypothesized that targeting intervention during the naturally motivating transition to&#xD;
      parenthood may not only provide opportunities for long lasting behavioral change for parents,&#xD;
      but also initiate a cascade of protective processes that ultimately reduce risk for negative&#xD;
      emotional and behavioral outcomes for children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 25, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</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>
    <intervention_model_description>In both arms, couples will experience a parenting program for expecting first time parents. In one arm, parents will receive an adapted Family Foundations program. In the other arm, parents will receive an empirically supported community parenting program.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants will be asked to participate in a parenting program but will not be informed about which arm of the study they have been assigned. To avoid bias in the evaluation of the interventions, outcome assessors will not be informed about which arm of the study participants have been assigned.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Couple Relationship/Co-parenting</measure>
    <time_frame>6 months of child age</time_frame>
    <description>Couple relationship will be evaluated through the Co-parenting Relationship Scale. For overall coparenting quality, average responses range from 0 (not true of us/never) to 6 (very true of us/very often). Lower scores indicate worse outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Adjustment</measure>
    <time_frame>6 months of child age</time_frame>
    <description>Parent adjustment will be assessed with self-report on mental health screenings. The Brief Symptom Inventory is a widely used mental health screening measure. Average responses to the listed symptoms range from 0 (not at all) to 4 (extremely) based on how distressing symptoms have been. Higher scores indicate greater intensity of symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Alcohol Use</measure>
    <time_frame>6 months of child age</time_frame>
    <description>Quantity-frequency of alcohol use (Quantity Frequency Index) and frequency of binge drinking (4 or 5 or more on a single occasion) based on the NIAAA standard drink will be assessed. Higher scores indicate greater quantity and frequency of alcohol use and binge drinking, with moderate drinking being defined as up to 1 standard drink per day for women and up to 2 standard drinks per day for men.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent-infant Interactions</measure>
    <time_frame>6 and 12 months of child age</time_frame>
    <description>Parent-child relations will be measured through the coding of play interaction sessions. Parental warmth, sensitivity, and harshness will be coded during parent-infant interactions. Parents will be asked to spend some time with their infants as they normally would at 6 months. At 12 months, parents will be asked to spend some time with infants as they normally would for the first 5 minutes, and given a series of problem-solving tasks to do with their infants for the next 5 minutes. Warmth (positive affective involvement), sensitivity (e.g., flexibility and contingent responsiveness), and harshness (e.g., intrusive and negative behaviors such as angry/hostile mood and voice, disapproval, and criticism) will be coded based on the global 5-point rating scales of the Early Relational Assessment (Clark, 1999). Higher scores on the rating scales indicate higher frequency of warmth, sensitivity, and harshness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Self-Regulation</measure>
    <time_frame>6 and 12 months of child age</time_frame>
    <description>The Revised Infant Behavior Questionnaire (IBQ-R, Gartstein &amp; Rothbart, 2003) will be used to obtain parent reports of infant reactivity/regulation at 6 and 12 months of infant ages. The scale measures three broad dimensions of behavior Surgency/Extraversion, Negative Affectivity, and Orienting/Regulation. The Surgency/Extraversion dimension includes approach, vocal reactivity, high intensity pleasure, smiling and laughter, activity level, and perceptual sensitivity. The Negative Affectivity dimension includes sadness, distress to limitations, fear, and low falling reactivity. The Orienting/Regulation dimension includes low intensity pleasure, cuddliness, duration of orienting, and soothability. Scores range from 1-7 and higher scores on each dimension reflect higher surgency, negative affect, and regulation. Average of maternal and paternal scores on these three broad dimensions will be included as the final outcome measures.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Parenting</condition>
  <condition>Parent-Child Relations</condition>
  <condition>Drinking, Alcohol</condition>
  <condition>Adjustment</condition>
  <arm_group>
    <arm_group_label>Healthy Foundations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A community-based parenting education program with individual family check ins will be implemented to all participants assigned to this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family Foundations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An adapted Family Foundations parenting program for expecting first time parents with individual family check ins will be implemented to all participants assigned to this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Foundations</intervention_name>
    <description>Healthy Foundations combines elements of a community-based parent education program with additional information about infant and child development, good parenting practices, parent health behavior, and couple support.</description>
    <arm_group_label>Healthy Foundations</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Foundations</intervention_name>
    <description>A modified version of Family Foundations, an evidence-based preventive intervention for couples during the transition to parenthood, will be implemented to address several aspects of parent and family adjustment, including parent health behavior, particularly alcohol use, and couple relationship dynamics, to promote a healthy parenting environment.</description>
    <arm_group_label>Family Foundations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant couples who are cohabitating&#xD;
&#xD;
          -  Parents are 18 years of age or older&#xD;
&#xD;
          -  Health behavior such as moderate to heavy drinking&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Plural pregnancy&#xD;
&#xD;
          -  Illicit drug use other than cannabis for either parent&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Rina D Eiden, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephanie Godleski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rochester Institute of Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rina D Eiden</last_name>
    <phone>814-863-7767</phone>
    <email>rde5106@psu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stephanie Godleski</last_name>
    <phone>585-475-2643</phone>
    <email>saggsh@rit.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meghan Leising, M.A</last_name>
      <phone>716-887-3317</phone>
      <email>mlcasey@buffalo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Craig Colder, PhD</last_name>
      <phone>716-645-0190</phone>
      <email>ccolder@buffalo.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Rochester Institute of Technology</name>
      <address>
        <city>Henrietta</city>
        <state>New York</state>
        <zip>14467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Godleski, PhD</last_name>
      <phone>585-475-2643</phone>
      <email>saggsh@rit.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Penn State University</investigator_affiliation>
    <investigator_full_name>Rina D. Eiden</investigator_full_name>
    <investigator_title>Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>Parenting</keyword>
  <keyword>Couple Relationship</keyword>
  <keyword>Alcohol and Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04441307
org study id: STUDY00003112
secondary id: 7R01AA027708-02
secondary id: SITE00000607,
nct id: NCT04441307
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to understand if a parenting program that helps couples learn to parent as a
      team and maintain a healthy lifestyle, such as maintaining safer levels of alcohol use,
      promotes parent and child health and well-being. Programs will be delivered prenatally and
      postnatally and will include both group classes and individualized sessions. A comprehensive
      assessment is administered during pregnancy and then at 6 and 12 months of child age. It is
      hypothesized that targeting intervention during the naturally motivating transition to
      parenthood may not only provide opportunities for long lasting behavioral change for parents,
      but also initiate a cascade of protective processes that ultimately reduce risk for negative
      emotional and behavioral outcomes for children.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In both arms, couples will experience a parenting program for expecting first time parents. In one arm, parents will receive an adapted Family Foundations program. In the other arm, parents will receive an empirically supported community parenting program.
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: Participants will be asked to participate in a parenting program but will not be informed about which arm of the study they have been assigned. To avoid bias in the evaluation of the interventions, outcome assessors will not be informed about which arm of the study participants have been assigned.
measure: Couple Relationship/Co-parenting
time frame: 6 months of child age
description: Couple relationship will be evaluated through the Co-parenting Relationship Scale. For overall coparenting quality, average responses range from 0 (not true of us/never) to 6 (very true of us/very often). Lower scores indicate worse outcomes.
measure: Parent Adjustment
time frame: 6 months of child age
description: Parent adjustment will be assessed with self-report on mental health screenings. The Brief Symptom Inventory is a widely used mental health screening measure. Average responses to the listed symptoms range from 0 (not at all) to 4 (extremely) based on how distressing symptoms have been. Higher scores indicate greater intensity of symptoms.
measure: Parent Alcohol Use
time frame: 6 months of child age
description: Quantity-frequency of alcohol use (Quantity Frequency Index) and frequency of binge drinking (4 or 5 or more on a single occasion) based on the NIAAA standard drink will be assessed. Higher scores indicate greater quantity and frequency of alcohol use and binge drinking, with moderate drinking being defined as up to 1 standard drink per day for women and up to 2 standard drinks per day for men.
measure: Parent-infant Interactions
time frame: 6 and 12 months of child age
description: Parent-child relations will be measured through the coding of play interaction sessions. Parental warmth, sensitivity, and harshness will be coded during parent-infant interactions. Parents will be asked to spend some time with their infants as they normally would at 6 months. At 12 months, parents will be asked to spend some time with infants as they normally would for the first 5 minutes, and given a series of problem-solving tasks to do with their infants for the next 5 minutes. Warmth (positive affective involvement), sensitivity (e.g., flexibility and contingent responsiveness), and harshness (e.g., intrusive and negative behaviors such as angry/hostile mood and voice, disapproval, and criticism) will be coded based on the global 5-point rating scales of the Early Relational Assessment (Clark, 1999). Higher scores on the rating scales indicate higher frequency of warmth, sensitivity, and harshness.
measure: Infant Self-Regulation
time frame: 6 and 12 months of child age
description: The Revised Infant Behavior Questionnaire (IBQ-R, Gartstein & Rothbart, 2003) will be used to obtain parent reports of infant reactivity/regulation at 6 and 12 months of infant ages. The scale measures three broad dimensions of behavior Surgency/Extraversion, Negative Affectivity, and Orienting/Regulation. The Surgency/Extraversion dimension includes approach, vocal reactivity, high intensity pleasure, smiling and laughter, activity level, and perceptual sensitivity. The Negative Affectivity dimension includes sadness, distress to limitations, fear, and low falling reactivity. The Orienting/Regulation dimension includes low intensity pleasure, cuddliness, duration of orienting, and soothability. Scores range from 1-7 and higher scores on each dimension reflect higher surgency, negative affect, and regulation. Average of maternal and paternal scores on these three broad dimensions will be included as the final outcome measures.
arm group label: Healthy Foundations
arm group type: Active Comparator
description: A community-based parenting education program with individual family check ins will be implemented to all participants assigned to this arm.
arm group label: Family Foundations
arm group type: Experimental
description: An adapted Family Foundations parenting program for expecting first time parents with individual family check ins will be implemented to all participants assigned to this arm.
intervention type: Behavioral
intervention name: Healthy Foundations
description: Healthy Foundations combines elements of a community-based parent education program with additional information about infant and child development, good parenting practices, parent health behavior, and couple support.
arm group label: Healthy Foundations
intervention type: Behavioral
intervention name: Family Foundations
description: A modified version of Family Foundations, an evidence-based preventive intervention for couples during the transition to parenthood, will be implemented to address several aspects of parent and family adjustment, including parent health behavior, particularly alcohol use, and couple relationship dynamics, to promote a healthy parenting environment.
arm group label: Family Foundations
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rina D Eiden, PhD
role: Principal Investigator
affiliation: Penn State
last name: Stephanie Godleski, PhD
role: Principal Investigator
affiliation: Rochester Institute of Technology
last name: Rina D Eiden
phone: 814-863-7767
email: rde5106@psu.edu
last name: Stephanie Godleski
phone: 585-475-2643
email: saggsh@rit.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Penn State University
investigator full name: Rina D. Eiden
investigator title: Professor of Psychology
mesh term: Alcohol Drinking
sharing ipd: No