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Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

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ClinicalTrials.gov Identifier: NCT04441307
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : April 1, 2022
Sponsor:
Collaborators:
Rochester Institute of Technology
University at Buffalo
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Rina D. Eiden, Penn State University

Tracking Information
First Submitted Date  ICMJE June 14, 2020
First Posted Date  ICMJE June 22, 2020
Last Update Posted Date April 1, 2022
Actual Study Start Date  ICMJE January 25, 2021
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Couple Relationship/Co-parenting [ Time Frame: 6 months of child age ]
    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.
  • Parent Adjustment [ Time Frame: 6 months of child age ]
    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.
  • Parent Alcohol Use [ Time Frame: 6 months of child age ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Parent-infant Interactions [ Time Frame: 6 and 12 months of child age ]
    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.
  • Infant Self-Regulation [ Time Frame: 6 and 12 months of child age ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting Co-Parenting and Reducing Hazardous Drinking in New Families
Official Title  ICMJE Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
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.
Primary Purpose: Prevention
Condition  ICMJE
  • Parenting
  • Parent-Child Relations
  • Drinking, Alcohol
  • Adjustment
Intervention  ICMJE
  • Behavioral: Healthy Foundations
    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.
  • Behavioral: Family Foundations
    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.
Study Arms  ICMJE
  • Active Comparator: Healthy Foundations
    A community-based parenting education program with individual family check ins will be implemented to all participants assigned to this arm.
    Intervention: Behavioral: Healthy Foundations
  • Experimental: Family Foundations
    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: Behavioral: Family Foundations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2020)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant couples who are cohabitating
  • Parents are 18 years of age or older
  • Health behavior such as moderate to heavy drinking
  • English speaking

Exclusion Criteria:

  • Plural pregnancy
  • Illicit drug use other than cannabis for either parent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rina D Eiden 814-863-7767 rde5106@psu.edu
Contact: Stephanie Godleski 585-475-2643 saggsh@rit.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04441307
Other Study ID Numbers  ICMJE STUDY00003112
7R01AA027708-02 ( U.S. NIH Grant/Contract )
SITE00000607, ( Other Identifier: Pennsylvania State University - Univ Park Local IRB Study ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Rina D. Eiden, Penn State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Penn State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Rochester Institute of Technology
  • University at Buffalo
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Rina D Eiden, PhD Penn State
Principal Investigator: Stephanie Godleski, PhD Rochester Institute of Technology
PRS Account Penn State University
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP