NCT01851577

Brief Summary

The purpose of this study is to determine the efficacy of Family Foundations that is to be delivered concurrently with home visiting. Delivered prenatally and postnatally, Family Foundations is a coparenting prevention program for new mothers and fathers that is designed to optimize child outcomes by teaching parents how to work together in raising their child. Using a randomized clinical trial design, families will be assigned to receive Family Foundations + home visiting or home visiting alone. A comprehensive assessment is administered at baseline and then at post-intervention, and 9 and 18 months later. It is hypothesized that families receiving Family Foundations will improve in their resolving of conflict from pre-intervention through follow-up. Additional anticipated outcomes are that those receiving the intervention will have more involved fathers, mothers and fathers will report less conflict, and children will have better emotional and behavioral outcomes relative to those who receive home visiting alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 18, 2020

Status Verified

July 1, 2018

Enrollment Period

6.2 years

First QC Date

May 7, 2013

Last Update Submit

February 16, 2020

Conditions

Keywords

CoparentingProblem solvingChild developmentFather involvement

Outcome Measures

Primary Outcomes (1)

  • mother and father resolving of conflict

    Mothers and fathers complete measures of conflict resolution, co-parenting, and problem-solving that reflect their ability to successfully resolve conflict.

    pre-intervention, post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention

Secondary Outcomes (1)

  • child development

    post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention

Other Outcomes (1)

  • father involvement in raising child

    pre-intervention, post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention

Study Arms (2)

Family Foundations coparenting program

EXPERIMENTAL

Family Foundations is a coparenting prevention program that will be administered concurrently with ongoing home visiting.

Behavioral: Family Foundations coparenting program

Home visiting

ACTIVE COMPARATOR

Home visiting "as usual" will be provided without the added Family Foundations coparenting prevention program.

Behavioral: Home visiting

Interventions

Family Foundations is a coparenting program for new mothers and fathers designed to teach them skills needed to parent together effectively and facilitate healthy child development. Family Foundations will be administered concurrently with home visiting.

Family Foundations coparenting program
Home visitingBEHAVIORAL

Home visiting is a child abuse prevention approach for new mothers designed to strengthen protective factors and mitigate risk factors in order to promote optimal child development.

Home visiting

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First time, prenatal mother participating in a home visiting program
  • Biological father interested in being involved with child
  • years of age or older
  • English speaking

You may not qualify if:

  • Current substance dependence
  • Current psychosis
  • Current intimate partner violence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (4)

  • Solmeyer AR, Feinberg ME, Coffman DL, Jones DE. The effects of the family foundations prevention program on coparenting and child adjustment: a mediation analysis. Prev Sci. 2014 Apr;15(2):213-223. doi: 10.1007/s11121-013-0366-x.

    PMID: 23404669BACKGROUND
  • 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: 20954763BACKGROUND
  • Ammerman RT, Putnam FW, Kopke JE, Gannon TA, Short JA, Van Ginkel JB, Clark MJ, Carrozza MA, Spector AR. Development and implementation of a quality assurance infrastructure in a multisite home visitation program in Ohio and Kentucky. J Prev Interv Community. 2007;34(1-2):89-107. doi: 10.1300/J005v34n01_05.

    PMID: 17890195BACKGROUND
  • Ammerman RT, Peugh JL, Teeters AR, Sakuma KK, Jones DE, Hostetler ML, Van Ginkel JB, Feinberg ME. Promoting parenting in home visiting: A CACE analysis of Family Foundations. J Fam Psychol. 2022 Mar;36(2):225-235. doi: 10.1037/fam0000888. Epub 2021 Jun 24.

Related Links

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Robert T. Ammerman, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 10, 2013

Study Start

May 1, 2013

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 18, 2020

Record last verified: 2018-07

Locations