Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441307
• Other study ID #: STUDY00003112
• Secondary ID: 7R01AA027708-02S
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: December 2023
• Source: Penn State University
• Contact: Rina D Eiden
• Phone: 814-863-7767
• Email: rde5106[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York
United States	Rochester Institute of Technology	Henrietta	New York

Sponsors (4)

Lead Sponsor	Collaborator
Penn State University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), Rochester Institute of Technology, University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Parent-infant Interactions	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
Secondary	Infant Self-Regulation	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