Interparental ConflictFF ProjectNCT01851577
Engaging Fathers in Home Visitation
A study testing Family Foundations coparenting program and Home visiting in people with Interparental Conflict and Parenting, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Interparental Conflict, Parenting, Parent-child Relations
- What is being tested?
- Family Foundations coparenting program and Home visiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Current substance dependence
- Current psychosis
- Current intimate partner violence
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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.
- Conditions
- Interparental Conflict, Parenting, Parent-child Relations, Fathers
- Being tested
- Family Foundations coparenting program, Home visiting
- Keywords
- Coparenting, Problem solving, Child development, Father involvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Foundations coparenting programBehavioural
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 visitingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Family Foundations coparenting program | Experimental | Family Foundations is a coparenting prevention program that will be administered concurrently with ongoing home visiting. Receives: Behavioral: Family Foundations coparenting program |
| Home visiting | Active comparator | Home visiting "as usual" will be provided without the added Family Foundations coparenting prevention program. Receives: Behavioral: Home visiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
child development
Children are on track developmentally at each assessment point
Measured: post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startMay 2013
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Interparental ConflictStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University
- Responsible party
- Sponsor
- Investigators
- Robert T. Ammerman, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851577
- Sponsor's protocol ID
- CIN001-EngagingFathers
- Other IDs
- 1R01HD069431-01A1
- Acronym
- FF Project
- Status last verified
- Jul 2018
- First submitted
- 7 May 2013
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23404669Feinberg 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.
PubMed 20954763Ammerman 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.
PubMed 17890195Ammerman 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.
PubMed 34166030
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Fathers in Home Visitation: Incorporation of a Coparenting Intervention
- ClinicalTrials.gov ID
- NCT01851577
- Acronym / sponsor ID
- FF Project / CIN001-EngagingFathers
- Conditions
- Interparental Conflict, Parenting, Parent-child Relations, Fathers
- Keywords
- Coparenting, Problem solving, Child development, Father involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University
- Study start
- May 2013
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Foundations coparenting program | Experimental | Behavioral: Family Foundations coparenting programFamily Foundations is a coparenting prevention program that will be administered concurrently with ongoing home visiting. |
| Home visiting | Active comparator | Behavioral: Home visitingHome visiting "as usual" will be provided without the added Family Foundations coparenting prevention program. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Current substance dependence
- Current psychosis
- Current intimate partner violence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Foundations coparenting programFamily 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. | Behavioural | Family Foundations coparenting program |
| Home visitingHome 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. | Behavioural | Home visiting |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Background: PubMed 23404669Solmeyer 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.
- Background: PubMed 20954763Feinberg 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.
- Background: PubMed 17890195Ammerman 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.
- Derived from this study: PubMed 34166030Ammerman 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.
- The FF Project is implemented in Every Child Succeeds, a regional home visiting program.Link provided by the sponsor.
Related trials for Interparental Conflict
Recruiting
Pilot Study of an Interparental Conflict Intervention for Separating or Divorcing Parents
Interparental Conflict, Child Mental Health
Recruiting
The New Beginnings Podcast: Brief Audio Intervention for Parents From Divorced and Separated Families
Parent Child Relationship, Parenting Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert T. Ammerman, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Foundations coparenting program and Home visiting in people with Interparental Conflict and Parenting, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01851577, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020; AzTrials last refreshed its copy on 1 Nov 2026.