Family Foundations Coparenting Pilot Trial (FF1)

February 3, 2021 updated by: Mark Feinberg, Penn State University

Promotion of Coparenting During Family Formation Period

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

497

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University, Prevention Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not first child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Couples in the Control group did not receive the Family Foundations Coparenting Program.
Experimental: Intervention Group
Couples randomly assigned to the Intervention Group received the Family Foundations Coparenting Program.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coparenting Quality
Time Frame: up to 3.5 years after 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.
up to 3.5 years after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Discipline Practices
Time Frame: 3.5 years after baseline
The Parenting Scale assesses discipline practices in parents of children from 18-48 months (Arnold,O'Leary, Wolff, & Acker, 1993).
3.5 years after baseline
Child Behavior Problems
Time Frame: 3.5 years after baseline

Child behavior problems were measured using the Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2000), reported by mothers only. From this 100-item questionnaire, separate sub-scales were calculated using scoring conventions. From these, we examined three overall scores which were normed for child age:

Total problems, Externalizing problems, and Internalizing problems. In addition, we examined two specific sub-scales given their relevance to this study: Aggression and Attention/Hyperactivity.
3.5 years after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MH64125-01A2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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