Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

NCT04441307 | Active Not Recruiting DMC

• 3 other identifiers: STUDY000031127R01AA027708-02SITE00000607,
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 2

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.

Conditions

Parenting; Parent-Child Relations; Drinking, Alcohol; Adjustment

Keywords

Parenting; Couple Relationship; Alcohol and Health

Outcome Measures

Primary Outcomes (3)

• Couple Relationship/Co-parenting

  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

  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

  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 Outcomes (2)

• Parent-infant Interactions

  6 and 12 months of child age

• Infant Self-Regulation

  6 and 12 months of child age

Study Arms (2)

Healthy Foundations

ACTIVE COMPARATOR

A community-based parenting education program with individual family check ins will be implemented to all participants assigned to this arm.

Behavioral: Healthy Foundations

Family Foundations

EXPERIMENTAL

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

Interventions

Healthy Foundations BEHAVIORAL

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.

Healthy Foundations

Family Foundations BEHAVIORAL

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.

Family Foundations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Plural pregnancy
• Illicit drug use other than cannabis during pregnancy

Sponsors & Collaborators

• Penn State University: lead
• Rochester Institute of Technology: collaborator
• University at Buffalo: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

University at Buffalo

Buffalo, New York, 14260, United States

Location

Rochester Institute of Technology

Henrietta, New York, 14467, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Rina D Eiden, PhD

  Penn State

  PRINCIPAL INVESTIGATOR

• Stephanie Godleski, PhD

  Rochester Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 22, 2020
• Study Start: January 25, 2021
• Primary Completion: January 19, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)