Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

December 16, 2023 updated by: Rina D. Eiden, Penn State University

Strong Foundations: Intervening to Promote Co-Parenting and Reduce Father Hazardous Drinking in Expectant Parents

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Stephanie Godleski
  • Phone Number: 585-475-2643
  • Email: saggsh@rit.edu

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14260
        • Recruiting
        • University at Buffalo
        • Contact:
        • Contact:
      • Henrietta, New York, United States, 14467
        • Recruiting
        • Rochester Institute of Technology
        • Contact:
          • Stephanie Godleski, PhD
          • Phone Number: 585-475-2643
          • Email: saggsh@rit.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months of child age
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.
6 months of child age
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.
6 months of child age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 and 12 months of child age
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.
6 and 12 months of child age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University at Buffalo
Rochester Institute of Technology

Investigators

  • Principal Investigator: Rina D Eiden, PhD, Penn State
  • Principal Investigator: Stephanie Godleski, PhD, Rochester Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 16, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003112
  • 7R01AA027708-02 (U.S. NIH Grant/Contract)
  • SITE00000607, (Other Identifier: Pennsylvania State University - Univ Park Local IRB Study ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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