NCT04098276

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,265 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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 used 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 were randomly assigned to a personalized online intervention or the standard online safety information/usual care control arm and safety, mental health and empowerment outcomes were assessed at 3, 6 and 12 months follow up. For the second stage randomization, women who did not report significant improvement in safety (i.e., reduction in IPV) and in empowerment from baseline to follow up points (i.e., non-responders) were 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, mental health and empowerment) were assessed at 6 and 12 months of re- randomization. By re-randomizing participants, the study assessed the relative effectiveness of two strategies for augmentation (text only or a combination of text and phone) on safety, mental health and empowerment outcomes among the non-responders of the online interventions. In addition, the study compared the non-responder group of women to the responder group of the online interventions to determine if the strategies of augmentation brought the non-responders to the level of responders on safety, mental health and empowerment.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-11
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2019-09-23
• Last updated: 2025-06-26
• Results posted: 2025-06-26

Locations

1 site across 1 country: United States