ViolenceNCT01811719
Enhanced Nurse Home Visitation to Prevent Intimate Partner Violence
A study testing Enhanced NFP (NFP+) and NFP as usual in people with Violence and Emotional Abuse, run by Portland State University at 1 site in United States.
Trial summary
An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This randomized trial of an intervention to assess and prevent intimate partner violence during pregnancy and the post-partum builds upon the David Olds model of nurse home visitation (Nurse Family Partnership or NFP) for high risk mothers… Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Emotional Abuse, Pregnancy
- What is being tested?
- Enhanced NFP (NFP+) and NFP as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Oct 2010
- 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 15 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- No more than 28th week of gestation
- Low income
- Speak English or Spanish
- Pregnant with first child
- Minimum of 15 years of age at time of entrance into study
Who cannot join
- Women experiencing high risk pregnancies
Trial locations and contacts
1 site in 1 country.
United States1 site
Multnomah County Health Department
Portland, Oregon, 97204
About this study
Official title: An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence
An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This randomized trial of an intervention to assess and prevent intimate partner violence during pregnancy and the post-partum builds upon the David Olds model of nurse home visitation (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be effective in multiple settings in preventing child abuse and enhancing maternal and child health and psychosocial outcomes. However, prior research has shown that the NFP intervention is not as effective in homes where there is intimate partner violence (IPV). Although the NFP by itself has reduced IPV in one setting, it has not in another. The proposed study will test the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice or empowerment model whereby women can choose among interventions related to her goal for her current intimate relationship. If IPV or emotional abuse or controlling behaviors are assessed, the intervention is based on two interventions shown to be effective in assessing for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker brochure driven intervention). For women desiring to enhance marital quality, the Markman and Stanley PREP model that has been shown to enhance relationship quality will be offered. The PREP model also has some preliminary evidence of preventing IPV. For women with other risk factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child abuse, substance abuse), community resource linkage (beyond referral) strategies as with the NFP model will be used to obtain community resources to address these risk factors. 250 women referred to the Multnomah County Health Department will be randomized to the experimental (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule during pregnancy and until the infant is 24 months old. The intervention will concentrate on the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome measurement (CTS2, WEB, TPMI, depression - Edinborough, \& parenting stress), will occur at 3 months before delivery, 9 months \& 21 months post-partum with multivariate MANOVA, SEM and growth curve analyses.
- Conditions
- Violence, Emotional Abuse, Pregnancy, Parenting
- Being tested
- Enhanced NFP (NFP+), NFP as usual
- Keywords
- Intimate Partner Physical Violence, Intimate Partner Emotional Abuse, Intimate Partner Controlling Behaivor, Pregnancy Outcomes, Quality of Parental Care Giving, Maternal Life Course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced NFP (NFP+)Behavioural
Also called Markman and Stanley Within My Reach Training Curriculum, McFarlane and Parker Brochure Driven Intervention
Women in the experimental group received three possible interventions. First they received regular and periodic structured intimate partner violence (IPV) assessments from their nurse. Those who indicted any IPV - whether physical violence or emotional abuse or controlling behavior - were then given the Parker-McFarlane Brochure Intervention. Finally, all women were provided the Markman and Stanley Within My Reach curriculum according to their needs and interests.
NFP as usualBehavioural
Also called Nurse Family Partnership
The Nurse Family Partnership is a well-known and widely used nurse home visit program developed by David Olds. It has been rigorously tested and replicated and is now considered a best practice.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced NFP (NFP+) | Experimental | Enhanced NFP(NFP+)provides for the usual NFP services plus a three-prong experimental preventive intervention:
1. Structured and regularly occuring assessments for intimate partner violence (IPV);
2. McFarlane and Parker Brochure Driven Intervention for women experiencing IPV, including safety planning, referrals, and advocacy; and
3. Markman and Stanley Within My Reach Training which is a skills-based curriculum delivered to all participants focusing on improving relationship deicsions and outcomes. Receives: Behavioral: Enhanced NFP (NFP+) |
| NFP as usual | Active comparator | The Nurse Family Partnership is a well-known and widely used nurse home visit program developed by David Olds. It has been rigorously tested and replicated and is now considered a best practice. Receives: Behavioral: NFP as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased Intimate Partner Physical Violence from Baseline to Two-Year Follow-Up.
Women were given several different standardized measures regarding the amount of physical violence they might be experiencing including the Strauss Conflict Tactic Scale (CTS2r), Relationship Danger Assessment (RDA), and Proximal Antecedents of Violent Episodes Scale (PAVE).
Measured: baseline, one year follow-up, and two year follow-up
Secondary outcomes (1)
Decreased Intimate Partner Emotional Abuse & Controlling Behaviors from Baseline to Two-Year Follow-Up.
The women in the sample were given several standardized measures regarding emotional abuse and controlling behaviors including the Straus Conflict Tactic Scale (CTS2r), Psychological Maltreatment of Women Inventory (PWMI), Relationship Locus of Control (RLC), Communication Patterns Questionnaire (CPQ), and Relationship Danger Assessment (RDA).
Measured: baseline, one year follow-up, and two year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startJan 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ViolenceStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynette Feder, University of Central Florida
- Investigators
- Lynette F Feder, PhD, Principal investigator, University of Central FloridaPhyllis Niolin, PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811719
- Sponsor's protocol ID
- CDC 555
- Status last verified
- Mar 2013
- First submitted
- 8 Mar 2013
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Li Q, Heyman RE, Palusci VJ, Cilenti D, Susser ES, Provencio-Vasquez E, Shi L, Feder L. A Randomized Controlled Trial of Relationship Education Within a Nurse Home Visiting Program to Improve Mental Health and Prevent Substance Use Among First-Time, Low-Income Mothers. Matern Child Health J. 2026 Nov 3. doi: 10.1007/s10995-026-04334-4. Online ahead of print.
PubMed 42977874Li Q, Riosmena F, Valverde PA, Zhou S, Amura C, Peterson KA, Palusci VJ, Feder L. Preventing intimate partner violence among foreign-born Latinx mothers through relationship education during nurse home visiting. J Nurs Manag. 2022 Sep;30(6):1639-1647. doi: 10.1111/jonm.13565. Epub 2022 Mar 7.
PubMed 35174575Feder L, Niolon PH, Campbell J, Whitaker DJ, Brown J, Rostad W, Bacon S. An Intimate Partner Violence Prevention Intervention in a Nurse Home Visitation Program: A Randomized Clinical Trial. J Womens Health (Larchmt). 2018 Dec;27(12):1482-1490. doi: 10.1089/jwh.2017.6599. Epub 2018 Oct 11.
PubMed 30311848
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT01811719
- Acronym / sponsor ID
- CDC 555
- Conditions
- Violence, Emotional Abuse, Pregnancy, Parenting
- Keywords
- Intimate Partner Physical Violence, Intimate Partner Emotional Abuse, Intimate Partner Controlling Behaivor, Pregnancy Outcomes, Quality of Parental Care Giving, Maternal Life Course
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Portland State UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Mar 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.
An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This randomized trial of an intervention to assess and prevent intimate partner violence during pregnancy and the post-partum builds upon the David Olds model of nurse home visitation (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be effective in multiple settings in preventing child abuse and enhancing maternal and child health and psychosocial outcomes. However, prior research has shown that the NFP intervention is not as effective in homes where there is intimate partner violence (IPV). Although the NFP by itself has reduced IPV in one setting, it has not in another. The proposed study will test the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice or empowerment model whereby women can choose among interventions related to her goal for her current intimate relationship. If IPV or emotional abuse or controlling behaviors are assessed, the intervention is based on two interventions shown to be effective in assessing for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker brochure driven intervention). For women desiring to enhance marital quality, the Markman and Stanley PREP model that has been shown to enhance relationship quality will be offered. The PREP model also has some preliminary evidence of preventing IPV. For women with other risk factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child abuse, substance abuse), community resource linkage (beyond referral) strategies as with the NFP model will be used to obtain community resources to address these risk factors. 250 women referred to the Multnomah County Health Department will be randomized to the experimental (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule during pregnancy and until the infant is 24 months old. The intervention will concentrate on the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome measurement (CTS2, WEB, TPMI, depression - Edinborough, \& parenting stress), will occur at 3 months before delivery, 9 months \& 21 months post-partum with multivariate MANOVA, SEM and growth curve analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced NFP (NFP+) | Experimental | Behavioral: Enhanced NFP (NFP+)Enhanced NFP(NFP+)provides for the usual NFP services plus a three-prong experimental preventive intervention: 1. Structured and regularly occuring assessments for intimate partner violence (IPV); 2. McFarlane and Parker Brochure Driven Intervention for women experiencing IPV, including safety planning, referrals, and advocacy; and 3. Markman and Stanley Within My Reach Training which is a skills-based curriculum delivered to all participants focusing on improving relationship deicsions and outcomes. |
| NFP as usual | Active comparator | Behavioral: NFP as usualThe Nurse Family Partnership is a well-known and widely used nurse home visit program developed by David Olds. It has been rigorously tested and replicated and is now considered a best practice. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- No more than 28th week of gestation
- Low income
- Speak English or Spanish
- Pregnant with first child
- Minimum of 15 years of age at time of entrance into study
Key exclusion criteria (1 listed)
- Women experiencing high risk pregnancies
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 |
|---|---|---|
| Enhanced NFP (NFP+)Also: Markman and Stanley Within My Reach Training Curriculum, McFarlane and Parker Brochure Driven InterventionWomen in the experimental group received three possible interventions. First they received regular and periodic structured intimate partner violence (IPV) assessments from their nurse. Those who indicted any IPV - whether physical violence or emotional abuse or controlling behavior - were then given the Parker-McFarlane Brochure Intervention. Finally, all women were provided the Markman and Stanley Within My Reach curriculum according to their needs and interests. | Behavioural | Enhanced NFP (NFP+) |
| NFP as usualAlso: Nurse Family PartnershipThe Nurse Family Partnership is a well-known and widely used nurse home visit program developed by David Olds. It has been rigorously tested and replicated and is now considered a best practice. | Behavioural | NFP as usual |
Primary outcome
Decreased Intimate Partner Physical Violence from Baseline to Two-Year Follow-Up.
Time frame: baseline, one year follow-up, and two year follow-up
Women were given several different standardized measures regarding the amount of physical violence they might be experiencing including the Strauss Conflict Tactic Scale (CTS2r), Relationship Danger Assessment (RDA), and Proximal Antecedents of Violent Episodes Scale (PAVE).
1 secondary outcome
Decreased Intimate Partner Emotional Abuse & Controlling Behaviors from Baseline to Two-Year Follow-Up.
Time frame: baseline, one year follow-up, and two year follow-up
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 19 Mar 2013.
- Derived from this study: PubMed 42977874Li Q, Heyman RE, Palusci VJ, Cilenti D, Susser ES, Provencio-Vasquez E, Shi L, Feder L. A Randomized Controlled Trial of Relationship Education Within a Nurse Home Visiting Program to Improve Mental Health and Prevent Substance Use Among First-Time, Low-Income Mothers. Matern Child Health J. 2026 Nov 3. doi: 10.1007/s10995-026-04334-4. Online ahead of print.
- Derived from this study: PubMed 35174575Li Q, Riosmena F, Valverde PA, Zhou S, Amura C, Peterson KA, Palusci VJ, Feder L. Preventing intimate partner violence among foreign-born Latinx mothers through relationship education during nurse home visiting. J Nurs Manag. 2022 Sep;30(6):1639-1647. doi: 10.1111/jonm.13565. Epub 2022 Mar 7.
- Derived from this study: PubMed 30311848Feder L, Niolon PH, Campbell J, Whitaker DJ, Brown J, Rostad W, Bacon S. An Intimate Partner Violence Prevention Intervention in a Nurse Home Visitation Program: A Randomized Clinical Trial. J Womens Health (Larchmt). 2018 Dec;27(12):1482-1490. doi: 10.1089/jwh.2017.6599. Epub 2018 Oct 11.
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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.
Lynette F Feder, PhD principal investigator
University of Central Florida
Phyllis Niolin, PhD principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced NFP (NFP+) and NFP as usual in people with Violence and Emotional Abuse, run by Portland State University 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 5 inclusion and 1 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 19 Mar 2013. 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?
Decreased Intimate Partner Physical Violence from Baseline to Two-Year Follow-Up. (time frame: baseline, one year follow-up, and two year follow-up). 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 NCT01811719, which also lists 3 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 19 Mar 2013.