Nurse-family Partnership (NFP) Curriculum Study

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Behavioral: NFP + IPV intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 16 years and older NFP program participants (woman with first live birth and living in poverty) English speaker Exclusion Criteria: - Woman who cannot communicate in English

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NFP + IPV intervention<br>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<br>* 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.<br>|
| No Intervention: NFP (standard care)<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months |  | Baseline, 3-, 6-,12-, 18-, and 24-month postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite Abuse Scale (CAS) | Validated 30-item research instrument that assesses exposure to physical, sexual and emotional abuse, harassment and combined severe abuse. | 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. | Baseline, 3-, 6-,12-, 18-, and 24-month postpartum | 
| PRIME-MD Patient Health Questionnaire (PHQ-9) | Depression measure. | Baseline, 3-, 6-,12-, 18-, and 24-month postpartum | 
| SPAN (Startle, Physiological arousal, Anger and Numbness) | Post-Traumatic Stress Disorder measure. | Baseline, 3-, 6-,12-, 18-, and 24-month postpartum | 
| The SF-12 (v. 2) | Mental and Physical Health | Baseline, 3-, 6-,12-, 18-, and 24-month postpartum | 
| The TWEAK | Screening tool for alcohol abuse/dependency. | Baseline, 3-, 6-,12-, 18-, and 24-month postpartum | 
| Drug Abuse Screening Tool (DAST) | Prescription and Street Drug Use. | 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. | Baseline, 3-, 6-,12-, 18-, and 24-month postpartum | 
| The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF) | Childhood maltreatment | 6-month postpartum | 
| The Childhood Trauma Questionnaire (CTQ) | Childhood maltreatment. | 6-month postpartum | 
| A modified version of the Health and Social Service Utilization questionnaire | Assessment of service utilization. | 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. | 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. | 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. | Collected from nurses at baseline, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Domestic Violence, Spouse Abuse