Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 492
- Locations
- 1
- Primary Endpoint
- Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
NFP + IPV intervention
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.
Intervention: NFP + IPV intervention (Behavioral)
NFP (standard care)
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- PRIME-MD Patient Health Questionnaire (PHQ-9)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
- The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)(6-month postpartum)
- The Public Health Nurses' Responses to Women Who Are Abused(Collected from nurses at baseline, 12 and 24 months)
- The TWEAK(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
- The Intimate Partner Violence Strategies Index (IPV Strategies)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
- The Childhood Trauma Questionnaire (CTQ)(6-month postpartum)
- Drug Abuse Screening Tool (DAST)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
- A modified version of the Health and Social Service Utilization questionnaire(6-,12-, 18-, and 24-month postpartum)
- Child Protection Service records(24-month postpartum)
- The Domestic Violence Survivor Assessment (DVSA)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
- The SF-12 (v. 2)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
- Child health outcomes(Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum)
- The Composite Abuse Scale (CAS)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
- SPAN (Startle, Physiological arousal, Anger and Numbness)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
Investigators
Harriet L. MacMillan
Professor of Pediatrics
McMaster University