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Completed

NCT Number: NCT01372098

Nurse-family Partnership (NFP) Curriculum Study

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.

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Key information

Conditions

Domestic Violence

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

600 S. Commonwealth Ave., #800

Los Angeles, California, 90005, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NFP + IPV intervention

Behavioral

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.

Primary outcomes

  1. 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

  1. The Composite Abuse Scale (CAS)

    Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

    Validated 30-item research instrument that assesses exposure to physical, sexual and emotional abuse, harassment and combined severe abuse.

  2. The Domestic Violence Survivor Assessment (DVSA)

    Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

    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.

  3. PRIME-MD Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

    Depression measure.

  4. SPAN (Startle, Physiological arousal, Anger and Numbness)

    Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

    Post-Traumatic Stress Disorder measure.

  5. The SF-12 (v. 2)

    Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

    Mental and Physical Health

  6. The TWEAK

    Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

    Screening tool for alcohol abuse/dependency.

  7. Drug Abuse Screening Tool (DAST)

    Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

    Prescription and Street Drug Use.

  8. The Intimate Partner Violence Strategies Index (IPV Strategies)

    Time frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

    Specific actions women take to cope with violence.

  9. The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)

    Time frame: 6-month postpartum

    Childhood maltreatment

  10. The Childhood Trauma Questionnaire (CTQ)

    Time frame: 6-month postpartum

    Childhood maltreatment.

  11. A modified version of the Health and Social Service Utilization questionnaire

    Time frame: 6-,12-, 18-, and 24-month postpartum

    Assessment of service utilization.

  12. 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

    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.

  13. Child Protection Service records

    Time frame: 24-month postpartum

    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.

  14. The Public Health Nurses' Responses to Women Who Are Abused

    Time frame: Collected from nurses at baseline, 12 and 24 months

    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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Annie E. Casey Foundation
  • Centers for Disease Control and Prevention
  • Public Health Agency of Canada (PHAC)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 13, 2011
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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