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Trial of Transition to Parenthood Program for Couples

Trial of Transition to Parenthood Program for Couples

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01907412
Acronym
FF2
Enrollment
1200
Registered
2013-07-25
Start date
2008-06-30
Completion date
2026-12-31
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parent-Child Relations

Keywords

First time parents, Coparenting, Family Foundations

Brief summary

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?

Interventions

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.

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* not first child

Design outcomes

Primary

MeasureTime frameDescription
Coparenting QualityUp to 2.5 years from baselineWe 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

MeasureTime frameDescription
Aggressive ParentingUp to 2.5 years after baselineAggressive parenting was measured using Parent-Child Conflict Tactics Scales (Straus et al., 1998).

Other

MeasureTime frameDescription
Cardiovascular disease risk8 years from baselineWe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026