The weWomen and ourCircle Intervention for Immigrant, Refugee and Indigenous Women

NCT03265847 | Completed DMC

• 2 other identifiers: IRB000621911R01HD081179-01
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in severity and frequency of physical violence

  The adapted version of the Revised Conflict Tactics Scale (CTS2; Straus 1996) is used to measure severity and frequency of the abusive or violent acts in intimate partner relationships. The CTS2 subscales include physical aggression, injury, psychological aggression and sexual coercion. Response categories range from 0=never to 6= more than 20 times within the past 12 months; 7 = not in referent period but happened before. Higher values on the measure within the past 12 months indicate severe or more frequent experiences of violence. The CTS-2 items are scored using the severity-times-frequency weighted score, as recommended by Straus.

  Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

Secondary Outcomes (4)

• Change in depressive symptoms

  Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

• Change in symptoms of post-traumatic stress disorder (PTSD)

  Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

• Change in overall empowerment

  Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

• Change in empowerment related to safety

  Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

Study Arms (2)

Culturally-tailored Safety Planning

EXPERIMENTAL

Women in the intervention group receive the SDA intervention with the culturally-specific DA integrated as appropriate to the target group (i.e., immigrant, refugee or indigenous).

Behavioral: Culturally-tailored Safety Planning

Usual Care

NO INTERVENTION

The control group receive non-DA informed usual safety planning resources modeled on national and state domestic violence online resources, but not provided with immediate and visual feedback to their level of danger or a tailored safety planning.

Interventions

Culturally-tailored Safety Planning BEHAVIORAL

The intervention will provide safety planning/referrals tailored to the DA

Culturally-tailored Safety Planning

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Arizona State University: collaborator
• University of Maryland, Baltimore: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Refugee Women's Clinic

Phoenix, Arizona, 85008, United States

Location

Study Officials

• Jacquelyn C Campbell, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 29, 2017
• Study Start: December 19, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)