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OpenTrials
Active, Not Recruiting

NCT Number: NCT01907412

Trial of Transition to Parenthood Program for Couples

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parent-Child Relations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University, Prevention Research Center

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • not first child

Treatment and study plan

Family Foundations Coparenting Program

Behavioral

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.

Primary outcomes

  1. Coparenting Quality

    Time frame: Up to 2.5 years from baseline

    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.

Secondary outcomes

  1. Aggressive Parenting

    Time frame: Up to 2.5 years after baseline

    Aggressive parenting was measured using Parent-Child Conflict Tactics Scales (Straus et al., 1998).

Other outcomes

  1. Cardiovascular disease risk

    Time frame: 8 years from baseline

    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).

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Acronym: FF2

Important dates

Study start
2008
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2013
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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