Clinical trial NCT03265847: The weWomen and ourCircle Intervention for Immigrant, Refugee and Indigenous Women
Official title: Impact of Culturally-Specific Danger Assessment on Safety, Mental Health and Empowerment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence, Domestic
Violence-Related Symptom
Keywords: intimate partner violence
safety planning
immigrant, refugee
Native American
risk for future violence
risk for intimate partner homicide
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: University of Maryland, Baltimore
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-08-29
Enrollment: 688
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the impact of administering culturally-specific versions of the Danger Assessment (DA) tool followed by the tailored safety planning/referral via use of internet/smartphone-based safety decision aid (SDA) on immigrant, refugee and indigenous women's empowerment, safety and mental health. Half of survivors will receive tailored safety planning/referral based on their level of risk assessed by the DA, while the other half will receive non-DA informed usual safety planning/referral.

Detailed description: The DA is a tool to assess risk for homicide, near homicide, re-assault or severe re-assault by an intimate partner. In the culturally adapted DA-informed safety decision aid intervention, women answer questions on the DA, receive immediate feedback on their level of danger as well as personalized messages about safety based on their scores on the DA. The risk factors and scores on the DA are then combined with the safety priorities of women to develop a tailored safety action with links to community resources. Using a computerized randomization scheme, women are randomly assigned to either the internet and/or smartphone app accessible SDA website or control website.

This trial is being conducted in various geographical regions in the US to address the following aims:

1. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on abused women's safety compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have increased safety seeking behaviors and reduced exposure to intimate partner violence in comparison to the control group.
2. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on abused women's mental health compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have improved mental health in comparison to the control group.
3. Evaluate the impact of administering culturally adapted DA-informed interactive internet-based SDA intervention on promoting abused women's empowerment compared to women assigned to the control website. It is hypothesized that at 3, 6, and 12 months post-baseline, the intervention group will have increased empowerment in comparison to the control group.

The study will establish evidence base for a culturally-informed intervention for immigrant, refugee and indigenous women. The intervention will not only prevent future exposure to intimate partner violence, it will also promote abused women's mental health and empowerment.

Eligibility criteria: Inclusion Criteria:

* Experiences of intimate partner violence within the past one year
* Foreign born immigrant or refugee woman OR Native American woman
* 18-64 years of age
* Can access and use internet

Exclusion Criteria:

* No experience of intimate partner violence within the past one year
* US born and not Native American
* Younger than 18 or older than 64
* Cannot access or use internet

Primary outcomes:
measure: Change in severity and frequency of physical violence
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary outcomes:
measure: Change in depressive symptoms
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in symptoms of post-traumatic stress disorder (PTSD)
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in overall empowerment
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
measure: Change in empowerment related to safety
timeFrame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Refugee Women's Clinic
state: Arizona
Study officials:
affiliation: Johns Hopkins University
name: Jacquelyn C Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: