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It's WeWomen Plus Intervention for Health, Safety and Empowerment (IWWP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098276
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Violence, Domestic Violence-Related Symptom Violence, Physical Violence, Sexual Violence, Gender-Based Violence Behavioral: WeWomen Plus technology based intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1266 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The study will use a sequential, multiple assignment, randomized (SMART) design
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: An Adaptive Intervention to Improve Health, Safety and Empowerment Outcomes Among Immigrant Women With Intimate Partner Violence Experiences
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

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.
Behavioral: WeWomen Plus technology based intervention
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
Behavioral: WeWomen Plus technology based intervention
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
Behavioral: WeWomen Plus technology based intervention
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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 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

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): NCT04098276


Contacts
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Contact: Bushra Sabri 4109557105 bsabri1@jhu.edu

Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Bushra Sabri Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04098276    
Other Study ID Numbers: IRB00224324
R01MD013863-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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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
risk for future violence
risk for intimate partner homicide
empowerment
mental health
safety