NCT01907412

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?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2008Dec 2026

Study Start

First participant enrolled

June 1, 2008

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

18.5 years

First QC Date

July 22, 2013

Last Update Submit

June 17, 2024

Conditions

Keywords

First time parentsCoparentingFamily Foundations

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Aggressive Parenting

    Up to 2.5 years after baseline

Other Outcomes (1)

  • Cardiovascular disease risk

    8 years from baseline

Study Arms (2)

Control Group

NO INTERVENTION

Couples in the Control group did not receive the Family Foundations Coparenting Program.

Intervention Group

EXPERIMENTAL

Couples randomly assigned to the Intervention Group received the Family Foundations Coparenting Program.

Behavioral: Family Foundations Coparenting Program

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • not first child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University, Prevention Research Center

University Park, Pennsylvania, 16802, United States

Location

Related Publications (5)

  • Aytuglu A, Graham-Engeland JE, Feinberg ME, Murray-Perdue SA, Conway CA, Schreier HMC. Longitudinal associations between father- and mother-child interactions, coparenting, and child cardiometabolic health. Health Psychol. 2025 Dec 1:10.1037/hea0001567. doi: 10.1037/hea0001567. Online ahead of print.

  • Aytuglu A, Graham-Engeland JE, Feinberg ME, Jones DE, Schreier HMC. Child sleep problems mediate prospective associations between fathers' parenting stress and child blood glucose levels. J Fam Psychol. 2025 Mar;39(2):277-283. doi: 10.1037/fam0001306. Epub 2025 Jan 16.

  • Schreier HMC, Feinberg ME, Jones DE, Ganguli A, Givens C, Graham-Engeland J. Children's empathy moderates the association between perceived interparental conflict and child health. Brain Behav Immun. 2024 May;118:128-135. doi: 10.1016/j.bbi.2024.02.022. Epub 2024 Feb 24.

  • Jones EJ, Feinberg ME, Graham-Engeland JE, Jones DE, Schreier HMC. A perinatal coparenting intervention: Effects of a randomized trial on parent cardiometabolic risk and self-reported health. Biol Psychol. 2023 Oct;183:108664. doi: 10.1016/j.biopsycho.2023.108664. Epub 2023 Aug 23.

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research professor

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 25, 2013

Study Start

June 1, 2008

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations