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Clinical Trials/NCT04441307
NCT04441307
Active, Not Recruiting
N/A

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

Penn State University2 sites in 1 country368 target enrollmentJanuary 25, 2021

Overview

Phase
N/A
Intervention
Healthy Foundations
Conditions
Parenting
Sponsor
Penn State University
Enrollment
368
Locations
2
Primary Endpoint
Parent Adjustment
Status
Active, Not Recruiting
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2021
End Date
July 31, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rina D. Eiden

Professor of Psychology

Penn State University

Eligibility Criteria

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 during pregnancy

Arms & Interventions

Healthy Foundations

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

Intervention: Healthy Foundations

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: Family Foundations

Outcomes

Primary 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.

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.

Secondary Outcomes

  • Parent-infant Interactions(6 and 12 months of child age)
  • Infant Self-Regulation(6 and 12 months of child age)

Study Sites (2)

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