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

Violence Clinical Trial

— IWWP  

Official title:

An Adaptive Intervention to Improve Health, Safety and Empowerment Outcomes Among Immigrant Women With Intimate Partner Violence Experiences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098276
• Other study ID #: IRB00224324
• Secondary ID: R01MD013863-01A1
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Bushra Sabri
• Phone: 4109557105
• Email: bsabri1[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1266
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Violence
• Violence, Domestic
• Violence, Gender-Based
• Violence, Physical
• Violence, Sexual
• Violence-Related Symptom

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of physical violence as assessed by the revised Conflict Tactics Scale	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	Change in depressive symptoms as assessed by the Patient Health Questionnaire (PHQ-9)	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
Secondary	Change in symptoms of post-traumatic stress disorder (PTSD) as assessed by the Harvard Trauma Questionnaire	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
Secondary	Change in overall empowerment as assessed by the Personal Progress Scale-Revised	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
Secondary	Change in empowerment related to safety as assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) scale	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