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

June 23, 2025 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1265

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WeWomen Plus Text messaging only
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
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.
Experimental: WeWomen Plus Text messaging and phone
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
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.
Experimental: Personalized Online Intervention
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
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.
No Intervention: Online usual care or Standard Online Safety Information
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Severity of Physical and Sexual Intimate Partner Violence as Assessed by the Revised Conflict Tactics Scale
Time Frame: Baseline (1st month), 3 months, 6 months, 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 3 months, 6 months, 12 months
The Patient Health Questionnaire (PHQ-9) was used to assess depression symptoms over the past two weeks based on DSM-IV diagnostic criteria for major depressive disorder. Each of the 9 items was scored from 0 (not at all) to 3 (nearly every day). Total scores were computed by summing all items, ranging from 0-27. Higher scores indicated more severe depression symptoms (1-4=minimal, 5-9=mild, 10-14=moderate, 15-19=moderately severe, 20-27=severe depression). Change scores were calculated as the differences between baseline PHQ-9 total scores and follow-up scores at each time point (3, 6, and 12 months).
Baseline, 3 months, 6 months, 12 months
Change in Symptoms of Post-traumatic Stress Disorder (PTSD) as Assessed by the Harvard Trauma Questionnaire
Time Frame: Baseline, 3 months, 6 months, 12 months
Past week PTSD symptoms were measured using the Harvard Trauma Questionnaire, a 16-item scale with response options that ranged from 1 (not at all) to 5 (extremely). Mean scores across all 16 items were calculated for each participant. Higher scores indicated more severe PTSD symptoms, with scores greater than 2.5 indicating clinically significant PTSD symptoms. Change scores were calculated as the differences between baseline mean scores and the follow-up mean scores at each time point (3, 6, and 12 months).
Baseline, 3 months, 6 months, 12 months
Change in Overall Empowerment as Assessed by the Personal Progress Scale-Revised
Time Frame: Baseline, 3 months, 6 months, 12 months
The Personal Progress Scale-Revised was used to measure empowerment across multiple domains including positive self-evaluation, self-esteem, emotional regulation, gender-role and cultural identity awareness, self-efficacy, self-care, problem-solving, and assertiveness skills. Participants rated 28 items on a 7-point scale from 1 (almost never) to 7 (almost always). Total scores were calculated by summing all items, ranging from 28-196, with higher scores indicating greater empowerment. Change scores were calculated as the differences between baseline total scores and follow-up scores at each time point (3, 6, and 12 months).
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
Time Frame: Baseline, 3 months, 6 months, 12 months
The MOVERS scale was used to measure empowerment within the safety domain, including safety-related goal development, self-efficacy beliefs, and knowledge of support resources. Participants rated 13 items on a 5-point scale from 1 (never true) to 5 (always true). Mean scores across all 13 items were calculated for each participant. Higher scores indicated greater safety-related empowerment. Change scores were calculated as the differences between baseline mean scores and follow-up mean scores at each time point (3, 6, and 12 months).
Baseline, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bushra Sabri, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00224324
  • R01MD013863-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol
    Information identifier: 10.1186/s12889-021-11930-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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