- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04098276
It's WeWomen Plus Intervention for Health, Safety and Empowerment (IWWP)
December 21, 2023 updated by: Johns Hopkins University
An Adaptive Intervention to Improve Health, Safety and Empowerment Outcomes Among Immigrant Women With Intimate Partner Violence Experiences
This study evaluates the impact of adaptive technology-based intervention (online, text and phone) "weWomenPlus" on safety, mental health and empowerment of abused immigrant women.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Intimate partner violence (IPV) disproportionately affects immigrant women.
However, immigrant women remain an understudied and underserved population in need for evidence-based rigorously evaluated culturally competent interventions that address the health and safety needs of immigrant women.
This study uses a sequential, multiple assignment, randomized trial (SMART) design to rigorously evaluate an adaptive culturally informed intervention tailored to needs of immigrant women with IPV experiences.
For the first stage randomization, participants will be randomly assigned to an online intervention or the usual care control arm and safety, mental health and empowerment outcomes will be assessed at 3, 6 and 12 months follow up.
For the second stage randomization, women who do not report significant improvement in safety (i.e., reduction in IPV) and in empowerment from baseline to follow up points (i.e., non-responders) will be re- randomized to the augmented intervention components (text only or a combination of text and phone) developed in the formative phase.
Data on outcomes (safety and empowerment) will be assessed at 6 and 12 months of re- randomization.
By re-randomizing participants, the study will assess the relative effectiveness of two strategies for augmentation (text only or a combination of text and phone) on safety and empowerment outcomes among the non-responders of the online intervention.
In addition, the study will compare the non-responder group of women to the responder group of the online intervention to determine if the strategies of augmentation brought the non-responders to the level of responders on safety and empowerment.
Finally, the study will identify facilitators and barriers to the adoption, implementation and maintenance of use of the original and augmented intervention by programs serving immigrant women and design strategies to decrease barriers and build on strengths.
Study Type
Interventional
Enrollment (Estimated)
1266
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bushra Sabri
- Phone Number: 4109557105
- Email: bsabri1@jhu.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Recruiting
- Johns Hopkins University
-
Contact:
- Bushra Sabri, MSW, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Experiences of intimate partner violence within the past one year
- Foreign born immigrant woman
- 18-64 years of age
- Can access and use internet and phone
Exclusion Criteria:
- No experience of intimate partner violence within the past one year
- US born
- Younger than 18 or older than 64
- Cannot access or use internet or phone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online weWomen Intervention
For first stage randomization, women in the intervention group receive the online safety planning intervention informed by culturally specific danger assessment (DA) tool.
|
The WeWomen Plus intervention is a technology based (online, text and phone)culturally tailored intervention designed to reduce the risk of future intimate partner violence or a homicide, improve mental health and increase empowerment of abused immigrant women.
|
No Intervention: Online usual care or no treatment control
Women in the control group receive the 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.
|
|
Experimental: WeWomen Plus Text messaging only
For second stage randomization, the text messaging intervention will follow-up with non-responder group of immigrant women (those who did not improve in intervention or control arms above) on their enactment of tailored (tailored to the DA Score and priorities) safety plan provided in the online weWomen intervention or non-tailored (standard list of resources) safety recommendations provided in the usual care control arm
|
The WeWomen Plus intervention is a technology based (online, text and phone)culturally tailored intervention designed to reduce the risk of future intimate partner violence or a homicide, improve mental health and increase empowerment of abused immigrant women.
|
Experimental: WeWomen Plus Text messaging and phone
Second stage randomization will involve both text (described above) and phone calls for non-responder group of women in intervention or control arm.
The phone calls will draw from motivational interviewing adapted for abused women, solution focused therapy and a strengths perspective to discuss women's safety concerns and other needs, and strategies to strengthen social support networks
|
The WeWomen Plus intervention is a technology based (online, text and phone)culturally tailored intervention designed to reduce the risk of future intimate partner violence or a homicide, improve mental health and increase empowerment of abused immigrant women.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in severity of physical violence as assessed by the revised Conflict Tactics Scale
Time Frame: 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.
|
Baseline, 3 months, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive symptoms as assessed by the Patient Health Questionnaire (PHQ-9)
Time Frame: 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).
|
Baseline, 3 months, 6 months, 12 months
|
Change in symptoms of post-traumatic stress disorder (PTSD) as assessed by the Harvard Trauma Questionnaire
Time Frame: 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.
|
Baseline, 3 months, 6 months, 12 months
|
Change in overall empowerment as assessed by the Personal Progress Scale-Revised
Time Frame: 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.
|
Baseline, 3 months, 6 months, 12 months
|
Change in empowerment related to safety as assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) scale
Time Frame: 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 "1=never true" to "5=always true".
The scores on the measure are summed and averaged to produce a total score.
The scores range from 13 to 65 with higher scores indicating a greater degree of empowerment related to safety.
|
Baseline, 3 months, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bushra Sabri, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2021
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 19, 2019
First Submitted That Met QC Criteria
September 19, 2019
First Posted (Actual)
September 23, 2019
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 21, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00224324
- R01MD013863-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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