- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01851577
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
Completed
Intervention / Treatment
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
Enrollment (Actual)
320
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Family Foundations coparenting program
Family Foundations is a coparenting prevention program that will be administered concurrently with ongoing home visiting.
|
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.
|
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
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
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
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.
Collaborators
Investigators
- 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
- 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.
- 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.
- 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.
- 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.
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
May 1, 2013
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
May 7, 2013
First Submitted That Met QC Criteria
May 8, 2013
First Posted (Estimate)
May 10, 2013
Study Record Updates
Last Update Posted (Actual)
February 18, 2020
Last Update Submitted That Met QC Criteria
February 16, 2020
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Parenting
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruiting
-
Johns Hopkins UniversityThe Rita and Alex Hillman Foundation; Abell Foundation; Richman Foundation; Sherman... and other collaboratorsRecruitingParenting | Parenting InterventionUnited States
-
Tampere University HospitalTampere UniversityCompletedParenting Satisfaction | Parenting Self-efficacyFinland
-
University of MinnesotaArizona State UniversityCompleted
-
WestatMakerere UniversityCompleted
-
Central Hospital, Nancy, FranceCompleted
-
Yale UniversityCompleted
-
Georgetown UniversityRecruiting
-
University of South FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedParentingUnited States
Clinical Trials on Family Foundations coparenting program
-
Penn State UniversityActive, not recruiting
-
Penn State UniversityCompleted
-
University of Illinois at ChicagoCentro Romero; Expanded Mental Health Services of Chicago; Corazon Community... and other collaboratorsNot yet recruitingSexually Transmitted Infections | Sexual Risk Behavior | Unplanned PregnancyUnited States
-
Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); State... and other collaboratorsRecruiting
-
Penn State UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University at Buffalo and other collaboratorsRecruitingParent-Child Relations | Parenting | Drinking, Alcohol | AdjustmentUnited States
-
Dartmouth-Hitchcock Medical CenterCompletedPediatric Obesity | Health Behavior | Body Mass Index | Self EsteemUnited States
-
University of Wisconsin, MadisonChan Zuckerberg InitiativeActive, not recruiting
-
University of Wisconsin, MadisonChan Zuckerberg Initiative; Healthy Minds Innovations; Center for Healthy MindsCompletedDepression | Anxiety | Psychological Distress | Well-being | Psychological StressUnited States
-
Social Insurance Institution, FinlandTurku University Hospital; University of TurkuCompletedADHD | Asperger Syndrome | Child Behavior DisordersFinland
-
Sorlandet Hospital HFCompleted