Trial of Transition to Parenthood Program for Couples (FF2)

This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby?

Study Overview

• Status: Active, not recruiting
• Conditions: Parent-Child Relations
• Intervention / Treatment: Behavioral: Family Foundations Coparenting Program

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State University, Prevention Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Expecting first child
• Couple living together and planning to raise child together
• 18 years or older

Exclusion Criteria:

• not first child

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Couples in the Control group did not receive the Family Foundations Coparenting Program.
Experimental: Intervention Group; Couples randomly assigned to the Intervention Group received the Family Foundations Coparenting Program.	Behavioral: Family Foundations Coparenting Program; Family Foundations, a program for adult couples expecting their first child, is designed to help them establish positive parenting skills and adjust to the physical, social, and emotional challenges of parenthood. Program topics include coping with postpartum depression and stress, creating a caring environment, and developing the child's social and emotional competence. Family Foundations is delivered to groups of couples through four prenatal and four postnatal classes of 2 hours each. Prenatal classes are started during the fifth or sixth month of pregnancy, and the postnatal classes end when the children are 6 months old. Family Foundations is delivered in a community setting by childbirth educators who have received 3 days of training from Family Foundations staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coparenting Quality	We assessed coparenting relationship quality with the 31-item Coparenting Scale, which was created based on prior work (e.g., Abidin & Brunner, 1995; Cordova, 2001; Frank, Olmstead, Wagner,& Laub, 1991; Margolin et al., 2001; McHale, 1997). The overall score represents an average of items covering theoretically important domains: coparental agreement, support,undermining, and exposure of the child to conflict.	Up to 2.5 years from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggressive Parenting	Aggressive parenting was measured using Parent-Child Conflict Tactics Scales (Straus et al., 1998).	Up to 2.5 years after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular disease risk	We assessed parent and child cardiovascular disease risk via inflammatory (C-reactive protein, Interleukin-6) and metabolic (total cholesterol, glycated hemoglobin, body mass index, blood pressure) outcomes previously linked to cardiovascular disease risk (e.g., Danesh et al., 2004; Goran et al., 2003; Ortega et al., 2016; Fuchs et al., 2020).	8 years from baseline

Collaborators and Investigators

• Sponsor: Penn State University

Publications and helpful links

General Publications

• Feinberg ME, Jones DE, Roettger ME, Hostetler ML, Sakuma KL, Paul IM, Ehrenthal DB. Preventive Effects on Birth Outcomes: Buffering Impact of Maternal Stress, Depression, and Anxiety. Matern Child Health J. 2016 Jan;20(1):56-65. doi: 10.1007/s10995-015-1801-3.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Coparenting; First time parents; Family Foundations
• Other Study ID Numbers: R01HD058529-02 (U.S. NIH Grant/Contract)