Violence, DomesticIWWPNCT04098276
It's WeWomen Plus Intervention for Health, Safety and Empowerment
A study testing WeWomen Plus technology based intervention in people with Violence, Domestic and Violence-Related Symptom, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Domestic, Violence-Related Symptom, Violence, Physical
- What is being tested?
- WeWomen Plus technology based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,265 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Violence, Domestic, Violence-Related Symptom, Violence, Physical, Violence, Sexual, Violence, Gender-Based, Violence
- Being tested
- WeWomen Plus technology based intervention
- Keywords
- Intimate partner violence, safety planning, immigrant, risk for future violence, risk for intimate partner homicide, empowerment, mental health, safety
- Medical subject headings
- Coitus, Empowerment, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeWomen Plus technology based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Behavioral: WeWomen Plus technology based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: Baseline, 3 months, 6 months, 12 months
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).
Measured: Baseline, 3 months, 6 months, 12 months
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).
Measured: 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
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).
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start11 Jan 2021
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Violence, DomesticStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study used a sequential, multiple assignment, randomized (SMART) design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Bushra Sabri, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098276
- Sponsor's protocol ID
- IRB00224324
- Other IDs
- R01MD013863-01A1
- Acronym
- IWWP
- Status last verified
- Jun 2025
- First submitted
- 19 Sep 2019
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Intervention to Improve Health, Safety and Empowerment Outcomes Among Immigrant Women With Intimate Partner Violence Experiences
- ClinicalTrials.gov ID
- NCT04098276
- Acronym / sponsor ID
- IWWP / IRB00224324
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,265 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The study used a sequential, multiple assignment, randomized (SMART) design
| Arm | Type | Receives |
|---|---|---|
| Personalized Online Intervention | Experimental | Behavioral: WeWomen Plus technology based interventionFor first stage randomization, women in the personalized online intervention group receive the online safety planning intervention informed by culturally specific danger assessment (DA) tool. |
| 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 | Behavioral: WeWomen Plus technology based interventionFor 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 |
| WeWomen Plus Text messaging and phone | Experimental | Behavioral: WeWomen Plus technology based interventionSecond 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeWomen Plus technology based interventionThe 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. | Behavioural | Personalized Online Intervention, WeWomen Plus Text messaging and phone, WeWomen Plus Text messaging only |
Primary outcome
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).
4 secondary outcomes
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: 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
Change in Overall Empowerment as Assessed by the Personal Progress Scale-Revised
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34711182Sabri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bushra Sabri principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeWomen Plus technology based intervention in people with Violence, Domestic and Violence-Related Symptom, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.