Engaging Fathers in Home Visitation

Parenting Clinical Trial

— FF Project  

Official title:

Engaging Fathers in Home Visitation: Incorporation of a Coparenting Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851577
• Other study ID #: CIN001-EngagingFathers
• Secondary ID: 1R01HD069431-01A
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fathers
• Interparental Conflict
• Parent-child Relations
• Parenting

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	father involvement in raising child	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
Primary	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	child development	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

External Links

•   The FF Project is implemented in Every Child Succeeds, a regional home visiting program.