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

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04098276
Study type	Interventional
Source	Johns Hopkins University
Contact	Bushra Sabri
Phone	4109557105
Email	bsabri1@jhu.edu
Status	Recruiting
Phase	N/A
Start date	January 11, 2021
Completion date	December 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms