Engaging Fathers in Home Visitation (FF Project)

February 16, 2020 updated by: Children's Hospital Medical Center, Cincinnati

Engaging Fathers in Home Visitation: Incorporation of a Coparenting Intervention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Home visitation is a prevention program for sociodemographically high risk, first-time mothers and their families that is designed to optimize child health and development. Most home visitation programs seek to engage fathers in the service and promote greater positive involvement with their children, although systematic and efficacious strategies to achieve this have not been developed and tested. Yet, it is well-documented that positive father involvement and mutually supportive relationships between fathers and mothers impart direct benefits to both children and their parents. Building upon previous efforts to incorporate evidence-based interventions into the home visitation setting, this study seeks to adapt Family Foundations, a coparenting intervention with a strong empirical foundation, as an augmented strategy in ongoing home visitation. In a first phase of qualitative investigation, we will adapt the format and content of Family Foundations for implementation in the home, addressing the needs of high risk mothers and fathers, and integrate it into standard home visitation services. In a second phase, a clinical trial will be conducted to determine the efficacy of the adapted intervention (HVFF) in contrast to a control condition of home visitation alone (HVA). Specifically, 300 mother/father dyads in home visitation will be recruited prenatally and randomly assigned to HVFF and HVA conditions. HVFF will consist of 8 in-home and 2 group sessions administered weekly and in two equal parts at approximately 2 months before birth and 4 months postpartum. Both the HVFF and HVA participants will be assessed at pre-intervention, post-intervention (5 months postpartum), and 9 and 18 month follow-ups. A comprehensive assessment battery will be administered at each assessment measuring parental cooperation, quality of parental relationship, father involvement, beliefs about parenting, parental psychological adjustment, and intimate partner violence. After the child's birth, child development and social/emotional adjustment will be measured and parenting practices will be videotaped and subsequently rated for parenting quality. It is hypothesized that, relative to controls, fathers in the HVFF condition will participate more frequently and more positively in standard home visits and will be more involved with their children; mothers and fathers in the HVFF condition will have higher levels of coparenting, and lower levels of depression, parental stress, and child abuse potential; and children in the HVFF condition will be more behaviorally and emotionally well-adjusted. Mediators of intervention outcomes will also be explored.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Family Foundations coparenting program
Family Foundations is a coparenting prevention program that will be administered concurrently with ongoing home visiting.
Behavioral: Family Foundations coparenting program
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.
Active Comparator: Home visiting
Home visiting "as usual" will be provided without the added Family Foundations coparenting prevention program.
Behavioral: Home visiting
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mother and father resolving of conflict
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
child development
Time Frame: post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention
Children are on track developmentally at each assessment point
post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
father involvement in raising child
Time Frame: 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
Fathers are actively involved in their child's life and have a decision-making role as measured by self-report and report by mothers at each assessment point.
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital Medical Center, Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert T. Ammerman, Ph.D., Children's Hospital Medical Center, Cincinnati

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

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIN001-EngagingFathers
  • 1R01HD069431-01A1 (U.S. NIH Grant/Contract)

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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