An interventional study of NFP + IPV intervention in Domestic Violence, sponsored by McMaster University. Completed at 1 site in United States. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-06-09.
Sponsored by McMaster University · Not applicable, Interventional, and Prevention
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.
McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Woman who cannot communicate in English
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.
Behavioral: NFP + IPV 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.
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.
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
The Composite Abuse Scale (CAS)
Validated 30-item research instrument that assesses exposure to physical, sexual and emotional abuse, harassment and combined severe abuse.
Time frame: 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.
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
PRIME-MD Patient Health Questionnaire (PHQ-9)
Depression measure.
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
SPAN (Startle, Physiological arousal, Anger and Numbness)
Post-Traumatic Stress Disorder measure.
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The SF-12 (v. 2)
Mental and Physical Health
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The TWEAK
Screening tool for alcohol abuse/dependency.
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
Drug Abuse Screening Tool (DAST)
Prescription and Street Drug Use.
Time frame: 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.
Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)
Childhood maltreatment
Time frame: 6-month postpartum
The Childhood Trauma Questionnaire (CTQ)
Childhood maltreatment.
Time frame: 6-month postpartum
A modified version of the Health and Social Service Utilization questionnaire
Assessment of service utilization.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Collected from nurses at baseline, 12 and 24 months
The record gives a start of May 2011, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.