Trial of Transition to Parenthood Program for Couples

Parent-Child Relations Clinical Trial

— FF2  

Official title:

Trial of Transition to Parenthood Program for Couples

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01907412
• Other study ID #: R01HD058529-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2008
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• not first child

Related Conditions & MeSH terms

• Parent-Child Relations

Intervention

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.

Locations

Country	Name	City	State
United States	Penn State University, Prevention Research Center	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Aggressive Parenting	Aggressive parenting was measured using Parent-Child Conflict Tactics Scales (Straus et al., 1998).	Up to 2.5 years after baseline