CClinicalTrials.gg
CompletedNCT04098276IWWPUpdated Jun 26, 2025Results posted

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

An interventional study of WeWomen Plus technology based intervention in Violence, Domestic, Violence-Related Symptom and Violence, Physical, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,265
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
1,265 participants (actual)

Study arms

  • 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

  • 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.

  • 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

  • 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

Interventions

  • BehavioralWeWomen 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.

05

What researchers measure

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).

    Time frame: Baseline (1st month), 3 months, 6 months, 12 months

Secondary outcomes

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

    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).

    Time frame: Baseline, 3 months, 6 months, 12 months

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

    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).

    Time frame: Baseline, 3 months, 6 months, 12 months

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

    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).

    Time frame: Baseline, 3 months, 6 months, 12 months

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

    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).

    Time frame: Baseline, 3 months, 6 months, 12 months

06

Results

Posted Jun 26, 2025

Participant flow

First Stage Randomization
Participant flow — First Stage Randomization
MilestonePersonalized Online InterventionOnline Usual Care or Standard Online Safety InformationWeWomen Plus Text Messaging OnlyWeWomen Plus Text Messaging and Phone
Started66060500
Completed61857300
Not completed423200
Second Stage Re-Randomization
Participant flow — Second Stage Re-Randomization
MilestonePersonalized Online InterventionOnline Usual Care or Standard Online Safety InformationWeWomen Plus Text Messaging OnlyWeWomen Plus Text Messaging and Phone
Started00183183
Completed00165156
Not completed001827

Outcome measures

PrimaryChange 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).

Time frame:
Baseline (1st month), 3 months, 6 months, 12 months
Reported as:
Mean · score on a scale
Change in Severity of Physical and Sexual Intimate Partner Violence as Assessed by the Revised Conflict Tactics Scale
score on a scalePersonalized Online InterventionOnline Usual Care or Standard Online Safety InformationWeWomen Plus Text Messaging OnlyWeWomen Plus Text Messaging and Phone
1-3 months-6.29 ± 22.56-5.16 ± 21.07-2.20 ± 20.01-1.82 ± 21.30
1-6 months-7.65 ± 22.35-5.62 ± 21.61-4.61 ± 20.63-8.27 ± 20.87
3- 6 months-0.81 ± 16.07-0.30 ± 18.96-1.74 ± 20.99-6.10 ± 19.33
3 -12 months-0.24 ± 20.810.03 ± 19.47-0.43 ± 19.73-4.94 ± 24.50
1-12 months-6.46 ± 22.15-5.22 ± 22.50-3.50 ± 23.34-7.27 ± 22.32
SecondaryChange in Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)

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).

Time frame:
Baseline, 3 months, 6 months, 12 months
Reported as:
Mean · score on a scale
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)
score on a scalePersonalized Online InterventionOnline Usual Care or Standard Online Safety InformationWeWomen Plus Text Messaging OnlyWeWomen Plus Text Messaging and Phone
1-3 months-0.41 ± 5.32-0.35 ± 5.230.83 ± 5.350.03 ± 4.71
1-6 months-1.04 ± 5.61-1.45 ± 5.79-1.20 ± 5.90-1.41 ± 5.58
3-6 months-0.66 ± 5.36-1.07 ± 5.43-2.02 ± 5.47-1.51 ± 5.41
3-12 months-0.87 ± 5.97-0.87 ± 5.66-1.79 ± 5.88-1.78 ± 5.70
1-12 months-1.20 ± 6.18-1.25 ± 6.02-0.95 ± 5.82-1.73 ± 5.31
SecondaryChange in Symptoms of Post-traumatic Stress Disorder (PTSD) as Assessed by the Harvard Trauma Questionnaire

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).

Time frame:
Baseline, 3 months, 6 months, 12 months
Reported as:
Mean · score on a scale
Change in Symptoms of Post-traumatic Stress Disorder (PTSD) as Assessed by the Harvard Trauma Questionnaire
score on a scalePersonalized Online InterventionOnline Usual Care or Standard Online Safety InformationWeWomen Plus Text Messaging OnlyWeWomen Plus Text Messaging and Phone
1-3 months-0.10 ± 0.75-0.11 ± 0.760.01 ± 0.76-0.09 ± 0.73
3-6 months-0.08 ± 0.71-0.06 ± 0.72-0.22 ± 0.79-0.09 ± 0.79
1-6 months-0.18 ± 0.78-0.18 ± 0.78-0.24 ± 0.87-0.19 ± 0.74
3-12 months-0.08 ± 0.81-0.04 ± 0.76-0.18 ± 0.83-0.14 ± 0.81
1-12 months-0.18 ± 0.82-0.17 ± 0.88-0.16 ± 0.82-0.27 ± 0.87
SecondaryChange in Overall Empowerment as Assessed by the Personal Progress Scale-Revised

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).

Time frame:
Baseline, 3 months, 6 months, 12 months
Reported as:
Mean · score on a scale
Change in Overall Empowerment as Assessed by the Personal Progress Scale-Revised
score on a scalePersonalized Online InterventionOnline Usual Care or Standard Online Safety InformationWeWomen Plus Text Messaging OnlyWeWomen Plus Text Messaging and Phone
1-3 months0.42 ± 16.300.66 ± 16.76-3.16 ± 15.89-5.10 ± 15.92
3-6 months1.20 ± 16.011.20 ± 15.732.74 ± 16.205.35 ± 16.71
1-6 months1.20 ± 17.811.81 ± 17.41-0.39 ± 16.23-0.05 ± 16.63
3-12 months1.46 ± 17.80-0.53 ± 16.622.59 ± 15.473.75 ± 16.85
1-12 months1.25 ± 20.520.33 ± 18.25-0.84 ± 17.09-1.35 ± 17.66
SecondaryChange in Empowerment Related to Safety as Assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) Scale

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).

Time frame:
Baseline, 3 months, 6 months, 12 months
Reported as:
Mean · score on a scale
Change in Empowerment Related to Safety as Assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) Scale
score on a scalePersonalized Online InterventionOnline Usual Care or Standard Online Safety InformationWeWomen Plus Text Messaging OnlyWeWomen Plus Text Messaging and Phone
1-3 months0.16 ± 0.710.10 ± 0.69-0.40 ± 0.45-0.39 ± 0.45
3-6 months-0.10 ± 0.70-0.06 ± 0.720.35 ± 0.640.29 ± 0.64
1-6 months0.08 ± 0.630.04 ± 0.65-0.04 ± 0.61-0.10 ± 0.63
3-12 months-0.09 ± 0.70-0.09 ± 0.720.34 ± 0.630.24 ± 0.58
1-12 months0.07 ± 0.680.02 ± 0.71-0.07 ± 0.54-0.16 ± 0.66

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Personalized Online Intervention0/660 (0%)0/660 (0%)0/660 (0%)
Online Usual Care or Standard Online Safety Information0/605 (0%)0/605 (0%)0/605 (0%)
WeWomen Plus Text Messaging Only0/183 (0%)0/183 (0%)0/183 (0%)
WeWomen Plus Text Messaging and Phone0/183 (0%)0/183 (0%)0/183 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Personalized Online InterventionStandard Online Safety InformationTotal
<=18 years8614
Between 18 and 65 years6525991251
>=65 years000
Age, Continuous
Age, Continuous(years)Personalized Online InterventionStandard Online Safety InformationTotal
Mean36.70 ± 9.8837.39 ± 9.6737.00 ± 9.80
Sex: Female, Male
Sex: Female, Male(Participants)Personalized Online InterventionStandard Online Safety InformationTotal
Female6606051265
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Personalized Online InterventionStandard Online Safety InformationTotal
Hispanic or Latino255269524
Not Hispanic or Latino396330726
Unknown or Not Reported9615
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Personalized Online InterventionStandard Online Safety InformationTotal
American Indian or Alaska Native358
Asian222164386
Native Hawaiian or Other Pacific Islander213
Black or African American8587172
White167189356
More than one race000
Unknown or Not Reported181159340
Physical and Sexual IPV
Physical and Sexual IPV(units on a scale)Personalized Online InterventionStandard Online Safety InformationTotal
Mean18.03 ± 25.5217.83 ± 25.0717.94 ± 25.29
Depression
Depression(units on a scale)Personalized Online InterventionStandard Online Safety InformationTotal
Mean9.98 ± 6.3910.39 ± 6.6110.18 ± 6.50
Post-traumatic Stress Disorder (PTSD)
Post-traumatic Stress Disorder (PTSD)(units on a scale)Personalized Online InterventionStandard Online Safety InformationTotal
Mean2.42 ± 0.932.50 ± 12.46 ± 0.96

2 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
08

References and documents

Publications

  • 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. PubMed 34711182 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 2, 2025

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT04098276
Lead sponsor
Johns Hopkins University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Sponsor
First posted
Sep 23, 2019
Start date
Jan 11, 2021
Primary completion
Jul 29, 2024
Completion
Jul 29, 2024
Results posted
Jun 26, 2025
Last update
Jun 26, 2025

Study contacts

Bushra Sabri
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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