Clinical trial NCT04098276: It's WeWomen Plus Intervention for Health, Safety and Empowerment
Official title: An Adaptive Intervention to Improve Health, Safety and Empowerment Outcomes Among Immigrant Women With Intimate Partner Violence Experiences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence, Domestic
Violence-Related Symptom
Violence, Physical
Violence, Sexual
Violence, Gender-Based
Violence
Keywords: Intimate partner violence
safety planning
immigrant
risk for future violence
risk for intimate partner homicide
empowerment
mental health
safety
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-09-23
Enrollment: 1265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study will use a sequential, multiple assignment, randomized (SMART) design
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in severity of physical violence as assessed by the revised Conflict Tactics Scale
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change in depressive symptoms as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in symptoms of post-traumatic stress disorder (PTSD) as assessed by the Harvard Trauma Questionnaire
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in overall empowerment as assessed by the Personal Progress Scale-Revised
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in empowerment related to safety as assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) scale
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Bushra Sabri
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sabri B, Glass N, Murray S, Perrin N, Case JR, Campbell JC. A technology-based intervention to improve safety, mental health and empowerment outcomes for immigrant women with intimate partner violence experiences: it's weWomen plus sequential multiple assignment randomized trial (SMART) protocol. BMC Public Health. 2021 Oct 28;21(1):1956. doi: 10.1186/s12889-021-11930-2.