NCT01901536

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

87
On Track

Trial Health Score

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

Enrollment
497

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2002

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

4.9 years

First QC Date

July 12, 2013

Last Update Submit

February 3, 2021

Conditions

Parent-Child Relations

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 3.5 years after baseline

Secondary Outcomes (2)

  • Parenting Discipline Practices

    3.5 years after baseline

  • Child Behavior Problems

    3.5 years after baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Family Foundations Coparenting Program

Control Group

NO INTERVENTION

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

Interventions

Family Foundations Coparenting ProgramBEHAVIORAL

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)

  • Feinberg ME, Jones DE, Kan ML, Goslin MC. Effects of family foundations on parents and children: 3.5 years after baseline. J Fam Psychol. 2010 Oct;24(5):532-42. doi: 10.1037/a0020837.

    PMID: 20954763RESULT

  • Feinberg ME, Kan ML, Goslin MC. Enhancing coparenting, parenting, and child self-regulation: effects of family foundations 1 year after birth. Prev Sci. 2009 Sep;10(3):276-85. doi: 10.1007/s11121-009-0130-4.

    PMID: 19381809RESULT

  • Feinberg ME, Kan ML. Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations. J Fam Psychol. 2008 Apr;22(2):253-63. doi: 10.1037/0893-3200.22.2.253.

    PMID: 18410212RESULT

  • Moran LJ, Lee JK, Jones D, Fronberg K, Feinberg ME. Coparenting-focused preventive intervention reduces postnatal maternal BMI and buffers impact of cortisol. Obesity (Silver Spring). 2022 Aug;30(8):1564-1572. doi: 10.1002/oby.23466. Epub 2022 Jul 19.

    PMID: 35854331DERIVED

  • Roettger ME, Schreier HMC, Feinberg ME, Jones DE. Prospective Relations Between Prenatal Maternal Cortisol and Child Health Outcomes. Psychosom Med. 2019 Jul/Aug;81(6):557-565. doi: 10.1097/PSY.0000000000000705.

    PMID: 31058707DERIVED

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 12, 2013

First Posted

July 17, 2013

Study Start

December 1, 2002

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

US(1)