Engaging Fathers in Home Visitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Putting Children First - Parent Training for Parents in High Conflict

NCT06809153

Parenting Behavior Parent Management Training Parent-Child Relations +1 more

NOT_YET_RECRUITING PHASE2

A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project

NCT01304719

Child Maltreatment

COMPLETED NA

Early Parenting Intervention Comparison

NCT01517867

Behavior Problems, Child

COMPLETED NA

Family Foundations Coparenting Pilot Trial

NCT01901536

Parent-Child Relations

COMPLETED NA

Coparenting, Infant Sleep, and Infant Development

NCT03187561

Sleep Parenting Marital Relationship +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interparental Conflict Parenting Parent-child Relations Fathers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Family Foundations coparenting program

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

Group Type EXPERIMENTAL

Family Foundations coparenting program

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Home visiting

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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