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Engaging Fathers in Home Visitation (FF Project)

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ClinicalTrials.gov Identifier: NCT01851577
Recruitment Status : Active, not recruiting
First Posted : May 10, 2013
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Interparental Conflict Parenting Parent-child Relations Fathers Behavioral: Family Foundations coparenting program Behavioral: Home visiting Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Engaging Fathers in Home Visitation: Incorporation of a Coparenting Intervention
Study Start Date : May 2013
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851577


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University
Investigators
Principal Investigator: Robert T. Ammerman, Ph.D. Children's Hospital Medical Center, Cincinnati