Domestic ViolenceNCT01372098
Nurse-family Partnership (NFP) Curriculum Study
A study testing NFP + IPV intervention in people with Domestic Violence, run by McMaster University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the Intimate Partner Violence (IPV) intervention in the context of Nurse-Family Partnership (NFP) program improves women's quality of life and reduces violence relative to the NFP alone using a cluster randomized controlled trial. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Domestic Violence
- What is being tested?
- NFP + IPV intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2015
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 years and older
- NFP program participants (woman with first live birth and living in poverty)
- English speaker
Who cannot join
- Woman who cannot communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
600 S. Commonwealth Ave., #800
Los Angeles, California, 90005
About this study
Official title: Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits
The purpose of this study is to determine whether the Intimate Partner Violence (IPV) intervention in the context of Nurse-Family Partnership (NFP) program improves women's quality of life and reduces violence relative to the NFP alone using a cluster randomized controlled trial. Our hypothesis is that an IPV intervention can be designed that is acceptable to participants in the NFP, feasible to implement, and that this intervention will improve quality of life for women and reduce exposure to violence.
- Conditions
- Domestic Violence
- Being tested
- NFP + IPV intervention
- Keywords
- Domestic Violence, Spouse Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NFP + IPV interventionBehavioural
The intervention focuses on helping women stay safe in a relationship. Strategies for overcoming barriers to using and accessing community resources and services, and community agency interventions for women exposed to IPV is built into the intervention.
| Study group | Role | What they receive |
|---|---|---|
| NFP + IPV intervention | Experimental | The protocol for number and timing of visits will be the same for both NFP+IPVI and Standard Care, as follows: weekly for the first four visits, every other week for the remainder of the pregnancy, every week for six weeks in the postpartum and every other week until the infant is 21 months old after which it is once a month for the last three months. We recognize that the intervention might prompt the nurse and mother to alter the regular visit schedule if IPV is present. Receives: Behavioral: NFP + IPV intervention |
| NFP (standard care) | No intervention | The NFP nurses currently receive some training regarding IPV, but it is minimal. Between intake and when the child is 3 months and 12 months old, there is a brief instruction that the nurse assess for IPV. If the client acknowledges current abuse when completing the Abuse Assessment Screen, the nurse should "assist her to evaluate threats to personal safety and make referrals as needed". There is a prompt to be mindful of client safety, and to make referrals as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
Secondary outcomes (14)
The Composite Abuse Scale (CAS)
Validated 30-item research instrument that assesses exposure to physical, sexual and emotional abuse, harassment and combined severe abuse.
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The Domestic Violence Survivor Assessment (DVSA)
Based on Prochaska's Transtheoretical Model of Behaviour Change (also known as "stages of change") and was developed by Dienemann and colleagues to gain a better understanding of battered women's cognitive states during counseling.
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
PRIME-MD Patient Health Questionnaire (PHQ-9)
Depression measure.
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
SPAN (Startle, Physiological arousal, Anger and Numbness)
Post-Traumatic Stress Disorder measure.
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The SF-12 (v. 2)
Mental and Physical Health
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The TWEAK
Screening tool for alcohol abuse/dependency.
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
Drug Abuse Screening Tool (DAST)
Prescription and Street Drug Use.
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The Intimate Partner Violence Strategies Index (IPV Strategies)
Specific actions women take to cope with violence.
Measured: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)
Childhood maltreatment
Measured: 6-month postpartum
The Childhood Trauma Questionnaire (CTQ)
Childhood maltreatment.
Measured: 6-month postpartum
A modified version of the Health and Social Service Utilization questionnaire
Assessment of service utilization.
Measured: 6-,12-, 18-, and 24-month postpartum
Child health outcomes
Data regarding the following child health outcomes are gathered by maternal interview: 1) birth weight; 2) length of gestation; 3) injuries; 4) emergency department visits (including those that are injury-related); 5) hospitalizations; 6) immunizations; and 7) developmental delay.
Measured: Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum
Child Protection Service records
Number of reports made, cases of confirmed child maltreatment, the type of maltreatment, the duration that cases were open, and whether children were placed in foster care or in custody of another family member.
Measured: 24-month postpartum
The Public Health Nurses' Responses to Women Who Are Abused
Nurses' readiness to treat IPV. In the 20-item PHNR, nurses respond to one of two scenarios that resemble real-life experiences they would encounter in a postpartum home visit. The instrument measures nurses' thoughts, feeling and actions in response to identifying and responding to IPV. The PHNR has good internal consistency with an overall Cronbach alpha of 0.79.
Measured: Collected from nurses at baseline, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Participant
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Public Health Agency of Canada (PHAC), Annie E. Casey Foundation
- Responsible party
- Principal investigator, Harriet L. MacMillan, McMaster University
- Investigators
- Harriet MacMillan, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372098
- Sponsor's protocol ID
- MacMillan_NFP_IPVI_RCT
- Status last verified
- Jun 2015
- First submitted
- 9 Jun 2011
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.
PubMed 34057734Jack SM, Boyle M, McKee C, Ford-Gilboe M, Wathen CN, Scribano P, Davidov D, McNaughton D, O'Brien R, Johnston C, Gasbarro M, Tanaka M, Kimber M, Coben J, Olds DL, MacMillan HL. Effect of Addition of an Intimate Partner Violence Intervention to a Nurse Home Visitation Program on Maternal Quality of Life: A Randomized Clinical Trial. JAMA. 2019 Apr 23;321(16):1576-1585. doi: 10.1001/jama.2019.3211.
PubMed 31012933
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits
- ClinicalTrials.gov ID
- NCT01372098
- Acronym / sponsor ID
- MacMillan_NFP_IPVI_RCT
- Conditions
- Domestic Violence
- Keywords
- Domestic Violence, Spouse Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Public Health Agency of Canada (PHAC), Annie E. Casey Foundation
- Study start
- May 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Jun 2011 (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 whether the Intimate Partner Violence (IPV) intervention in the context of Nurse-Family Partnership (NFP) program improves women's quality of life and reduces violence relative to the NFP alone using a cluster randomized controlled trial. Our hypothesis is that an IPV intervention can be designed that is acceptable to participants in the NFP, feasible to implement, and that this intervention will improve quality of life for women and reduce exposure to violence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NFP + IPV intervention | Experimental | Behavioral: NFP + IPV interventionThe protocol for number and timing of visits will be the same for both NFP+IPVI and Standard Care, as follows: weekly for the first four visits, every other week for the remainder of the pregnancy, every week for six weeks in the postpartum and every other week until the infant is 21 months old after which it is once a month for the last three months. We recognize that the intervention might prompt the nurse and mother to alter the regular visit schedule if IPV is present. |
| NFP (standard care) | No intervention | –The NFP nurses currently receive some training regarding IPV, but it is minimal. Between intake and when the child is 3 months and 12 months old, there is a brief instruction that the nurse assess for IPV. If the client acknowledges current abuse when completing the Abuse Assessment Screen, the nurse should "assist her to evaluate threats to personal safety and make referrals as needed". There is a prompt to be mindful of client safety, and to make referrals as needed. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 16 years and older
- NFP program participants (woman with first live birth and living in poverty)
- English speaker
Key exclusion criteria (1 listed)
- Woman who cannot communicate in English
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 |
|---|---|---|
| NFP + IPV interventionThe intervention focuses on helping women stay safe in a relationship. Strategies for overcoming barriers to using and accessing community resources and services, and community agency interventions for women exposed to IPV is built into the intervention. | Behavioural | NFP + IPV intervention |
Primary outcome
Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
14 secondary outcomes
The Composite Abuse Scale (CAS)
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The Domestic Violence Survivor Assessment (DVSA)
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
PRIME-MD Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
SPAN (Startle, Physiological arousal, Anger and Numbness)
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The SF-12 (v. 2)
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The TWEAK
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
Drug Abuse Screening Tool (DAST)
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The Intimate Partner Violence Strategies Index (IPV Strategies)
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)
Time frame: 6-month postpartum
The Childhood Trauma Questionnaire (CTQ)
Time frame: 6-month postpartum
A modified version of the Health and Social Service Utilization questionnaire
Time frame: 6-,12-, 18-, and 24-month postpartum
Child health outcomes
Time frame: Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum
Child Protection Service records
Time frame: 24-month postpartum
The Public Health Nurses' Responses to Women Who Are Abused
Time frame: Collected from nurses at baseline, 12 and 24 months
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 9 Jun 2015.
- Derived from this study: PubMed 34057734Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.
- Derived from this study: PubMed 31012933Jack SM, Boyle M, McKee C, Ford-Gilboe M, Wathen CN, Scribano P, Davidov D, McNaughton D, O'Brien R, Johnston C, Gasbarro M, Tanaka M, Kimber M, Coben J, Olds DL, MacMillan HL. Effect of Addition of an Intimate Partner Violence Intervention to a Nurse Home Visitation Program on Maternal Quality of Life: A Randomized Clinical Trial. JAMA. 2019 Apr 23;321(16):1576-1585. doi: 10.1001/jama.2019.3211.
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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.
Harriet MacMillan, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NFP + IPV intervention in people with Domestic Violence, run by McMaster 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 3 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 9 Jun 2015. 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?
Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months (time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum). 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 NCT01372098, which also lists 2 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 9 Jun 2015.