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

NCT04098276 | Completed Results

• 2 other identifiers: IRB00224324R01MD013863-01A1
• Study Type: interventional
• Target: 1,265
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Physical and Sexual Intimate Partner Violence as Assessed by the Revised Conflict Tactics Scale

  The adapted version of the Revised Conflict Tactics Scale (CTS2; Straus, 1996) was used to measure the severity and frequency of abusive or violent acts in intimate partner relationships. The CTS2 subscales included physical aggression, injury, psychological aggression, and sexual coercion. Response categories ranged from 0=never to 4=very frequently. Total scores ranged from 0-164, with higher scores indicating greater frequency and severity of intimate partner violence experiences. Items were scored using the severity-times-frequency weighted score method as recommended by Straus (1996). Change scores were calculated as the differences between baseline CTS-2 total scores and follow-up scores at each time point (3, 6, and 12 months).

  Baseline (1st month), 3 months, 6 months, 12 months

Secondary Outcomes (4)

• Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)

  Baseline, 3 months, 6 months, 12 months

• Change in Symptoms of Post-traumatic Stress Disorder (PTSD) as Assessed by the Harvard Trauma Questionnaire

  Baseline, 3 months, 6 months, 12 months

• Change in Overall Empowerment as Assessed by the Personal Progress Scale-Revised

  Baseline, 3 months, 6 months, 12 months

• Change in Empowerment Related to Safety as Assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) Scale

  Baseline, 3 months, 6 months, 12 months

Study Arms (4)

Personalized Online Intervention

EXPERIMENTAL

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

Behavioral: WeWomen Plus technology based intervention

Online usual care or Standard Online Safety Information

NO INTERVENTION

Women in the Standard Online Safety Information received 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

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

Behavioral: WeWomen Plus technology based intervention

WeWomen Plus Text messaging and phone

EXPERIMENTAL

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

Behavioral: WeWomen Plus technology based intervention

Interventions

WeWomen Plus technology based intervention BEHAVIORAL

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.

Personalized Online Intervention; WeWomen Plus Text messaging and phone; WeWomen Plus Text messaging only

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Experiences of intimate partner violence within the past one year
• Foreign born immigrant woman
• years of age
• Can access and use internet and phone

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 34711182 BACKGROUND

MeSH Terms

Conditions

Coitus; Empowerment; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Social Behavior; Personal Satisfaction

Results Point of Contact

• Title: Bushra Sabri
• Organization: Johns Hopkins University

bsabri1@jhu.edu

+1 (410) 955-7105

Study Officials

• Bushra Sabri

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study used a sequential, multiple assignment, randomized (SMART) design

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: January 11, 2021
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Locations

US (1)