Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

NCT ID: NCT04441307

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Parenting Parent-Child Relations Drinking, Alcohol Adjustment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Healthy Foundations

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

Group Type ACTIVE_COMPARATOR

Healthy Foundations

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Family Foundations

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rochester Institute of Technology

OTHER

Sponsor Role collaborator

University at Buffalo

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Rina D. Eiden

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rina D Eiden, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State

Stephanie Godleski, PhD

Role: PRINCIPAL_INVESTIGATOR

Rochester Institute of Technology

Locations

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University at Buffalo

Buffalo, New York, United States

Site Status

Rochester Institute of Technology

Henrietta, New York, United States

Site Status

Countries

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United States

Other Identifiers

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7R01AA027708-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SITE00000607,

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00003112

Identifier Type: -

Identifier Source: org_study_id

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