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Trial record 64 of 82 for:    emotional | Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

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ClinicalTrials.gov Identifier: NCT03265847
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Arizona State University
University of Maryland
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Violence, Domestic Violence-Related Symptom Behavioral: Culturally-tailored Safety Planning Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Impact of Culturally-Specific Danger Assessment on Safety, Mental Health and Empowerment
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2018

Arm Intervention/treatment
Experimental: Culturally-tailored Safety Planning
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
The intervention will provide safety planning/referrals tailored to the DA

No Intervention: Usual Care
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.



Primary Outcome Measures :
  1. Change in severity and frequency of physical violence [ Time Frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months) ]
    The adapted version of the revised Conflict Tactics Scale (CTS-2; Straus et al., 1996). The items on the CTS-2 are scored using the severity-times-frequency weighted score, as recommended by Straus (2004).


Secondary Outcome Measures :
  1. Change in depressive symptoms [ Time Frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months) ]
    The Patient Health Questionnaire (PHQ-9) is a 9 item measure to assess depression symptoms based on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual (DSM-IV). Each of the 9 items scores from 0 (not at all) to 3 (nearly every day).

  2. Change in symptoms of post-traumatic stress disorder (PTSD) [ Time Frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months) ]
    Harvard Trauma Questionnaire (16 items) is used to measure symptoms of PTSD derived from the DSM-IIR/DSM-IV criteria for PTSD. The scale for each question includes four categories of response: "Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively

  3. Change in overall empowerment [ Time Frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months) ]
    The Personal Progress Scale-Revised (PPS-R; Johnson et al., 2005) is a 28 item self-report measure of empowerment designed to assess multiple areas associated with empowerment such as positive self-evaluation, self-esteem, ability to regulate emotional distress, gender-role and cultural identity awareness, self-efficacy, self-care, problem-solving, assertiveness skills, and access to resources. Item responses are rated on a 7-point scale ranging from 1 (Almost Never) to 7 (Almost Always).

  4. Change in empowerment related to safety [ Time Frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months) ]
    The MOVERS is a 13 item scale that measures empowerment within the domain of safety. Participants respond to each item using a five-point scale from "never true" to "always true"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265847


Contacts
Contact: Bushra Sabri, PhD 410-955-7105 bsabri1@jhu.edu

Locations
United States, Arizona
Refugee Women's Clinic Recruiting
Phoenix, Arizona, United States, 85008
Contact: Crista Johnson-Agbakwu, MD,MSc,FACOG    602-344-5407      
Sponsors and Collaborators
Johns Hopkins University
Arizona State University
University of Maryland
Investigators
Principal Investigator: Jacquelyn C Campbell, PhD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03265847     History of Changes
Other Study ID Numbers: IRB00062191
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will only be available to the investigators and research team members of the project.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
intimate partner violence
safety planning
immigrant, refugee
Native American
risk for future violence
risk for intimate partner homicide