- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03265847
The weWomen and ourCircle Intervention for Immigrant, Refugee and Indigenous Women
Impact of Culturally-Specific Danger Assessment on Safety, Mental Health and Empowerment
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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.
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85008
- Refugee Women's Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 (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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 past two weeks depression symptoms based on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual (DSM-IV).
Each of the 9 items score from 0 (not at all) to 3 (nearly every day).
A total score is computed to measure severity of depression by summing the items.
Higher scores indicate more severe depression symptoms (1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, and 20-27= severe depression).
|
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)
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, with scores ranging from 1 to 4. The items represent intrusion/re-experiencing, avoidance/numbing and hypervigilance/arousal symptom clusters.
The scale for each question includes four categories of response: "1=Not at all," "2=A little," "3=quite a bit," "4=extremely," rated 1 to 4. A total score is obtained using the mean of responses to the items.
Higher scores indicate more severe PTSD symptoms.
|
Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
|
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.
Participants' responses are rated on a 7-point scale ranging from 1 (Almost Never) to 7 (Almost Always).
The items are summed to create a total score for empowerment.
The range of scores is 28-196 with higher scores indicating a greater degree of 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
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 (e.g., extent to which a participant has developed a set of safety-related goals and a belief in her ability to accomplish them, the extent to which she feels that her efforts to achieve safety trigger new difficulties and extent to which she has knowledge about and access to support).
Participants respond to each item using a five-point scale from "never true" to "always true".
The scores on the measure are summed and averaged to produce a total score.
Higher scores indicate a greater degree of empowerment related to safety.
|
Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacquelyn C Campbell, PhD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00062191
- 1R01HD081179-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Violence, Domestic
-
Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
-
Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
-
University of the Virgin IslandsUnknownDomestic Violence | Domestic AbuseVirgin Islands (U.S.)
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
Funmilola OlaOlorunUniversity of IbadanCompletedDomestic Violence | Violence | AttitudeNigeria
-
Yale UniversityOffice on Violence Against Women (OVW)Not yet recruiting
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingDomestic ViolencePeru
-
Medical University of South CarolinaAgency for Healthcare Research and Quality (AHRQ)Completed
Clinical Trials on Culturally-tailored Safety Planning
-
University of North Carolina, Chapel HillPatient-Centered Outcomes Research Institute; Children's Hospital of Philadelphia and other collaboratorsRecruitingA Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism SpectrumSuicidal Ideation | Suicide | Autism Spectrum Disorder | Suicidal and Self-injurious BehaviorUnited States
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); Dana-Farber Cancer Institute; Stanford University and other collaboratorsCompletedCigarette Smoking BehaviorUnited States
-
University of Colorado, DenverWashington State University; Missouri Breaks Industries Research, Inc.RecruitingAlzheimer DiseaseUnited States
-
University of Missouri, Kansas CityChildren's Mercy Hospital Kansas City; University of Massachusetts, Amherst; University... and other collaboratorsRecruitingPreDiabetes | Overweight and ObesityUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; Columbia University; United States Department of... and other collaboratorsCompletedSuicide, Attempted | SuicideUnited States
-
Washington State UniversityOptum, Inc.Completed
-
University of PennsylvaniaUnited States Department of DefenseCompleted
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)UnknownNovel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care (Namaste)Type 2 Diabetes MellitusCanada
-
University of Illinois at ChicagoRockefeller UniversityNot yet recruitingNeoplasms | Advance Care Planning
-
Loyola UniversityRecruiting