Violence, DomesticNCT03265847
The weWomen and ourCircle Intervention for Immigrant, Refugee and Indigenous Women
A study testing Culturally-tailored Safety Planning in people with Violence, Domestic and Violence-Related Symptom, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Domestic, Violence-Related Symptom
- What is being tested?
- Culturally-tailored Safety Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2017to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Culturally-Specific Danger Assessment on Safety, Mental Health and Empowerment
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.
Read the 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.
- Conditions
- Violence, Domestic, Violence-Related Symptom
- Being tested
- Culturally-tailored Safety Planning
- Keywords
- intimate partner violence, safety planning, immigrant, refugee, Native American, risk for future violence, risk for intimate partner homicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-tailored Safety PlanningBehavioural
The intervention will provide safety planning/referrals tailored to the DA
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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)
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.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in overall empowerment
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.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in empowerment related to safety
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.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start19 Dec 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence, DomesticStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, University of Maryland, Baltimore, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jacquelyn C Campbell, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265847
- Sponsor's protocol ID
- IRB00062191
- Other IDs
- 1R01HD081179-01
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2017
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Culturally-Specific Danger Assessment on Safety, Mental Health and Empowerment
- ClinicalTrials.gov ID
- NCT03265847
- Acronym / sponsor ID
- IRB00062191
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Arizona State University, University of Maryland, Baltimore, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally-tailored Safety Planning | Experimental | Behavioral: Culturally-tailored Safety PlanningWomen 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). |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally-tailored Safety PlanningThe intervention will provide safety planning/referrals tailored to the DA | Behavioural | Culturally-tailored Safety Planning |
Primary outcome
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.
4 secondary outcomes
Change in depressive symptoms
Time frame: 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)
Change in overall empowerment
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacquelyn C Campbell, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally-tailored Safety Planning in people with Violence, Domestic and Violence-Related Symptom, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.