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

Johns Hopkins University

Status: Completed

Conditions: Violence, Sexual; Violence, Physical; Violence-Related Symptom; Violence, Domestic; Violence, Gender-Based; Violence

Treatments: Behavioral: WeWomen Plus technology based intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04098276

IRB00224324

R01MD013863-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,265 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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1,265 participants in 4 patient groups

Online weWomen Intervention

Experimental group

Description:

For first stage randomization, women in the intervention group receive the online safety planning intervention informed by culturally specific danger assessment (DA) tool.

Treatment:

Behavioral: WeWomen Plus technology based intervention

Online usual care or no treatment control

No Intervention group

Description:

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.

WeWomen Plus Text messaging only

Experimental group

Description:

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

Treatment:

Behavioral: WeWomen Plus technology based intervention

WeWomen Plus Text messaging and phone

Experimental group

Description:

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

Treatment:

Behavioral: WeWomen Plus technology based intervention