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
Among 19 studies in Empowerment with a site in United States — 2 open to participants now, 5 under way, none of them phase 3. Empowerment · United States.
Among the 19 studies in Empowerment with a site in United States, this one has the largest enrollment of the 18 interventional ones that give a count, is the only one that started in 2021, is one of 16 with no phase, and was the 11th registered.
154 studies on the registry are indexed under Empowerment; 31 are open to participants now.
Browse Empowerment studies →2 of the 19 studies in Empowerment with a site in United States are open now. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Yang Li · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 15 Empowerment studies recruiting now, 7 (47%) set no upper age limit and 7 (47%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 64 Years · female · healthy volunteers too.
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19 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2021.
This study's enrollment of 1,265 is above the median of 141 across 132 interventional studies indexed under Empowerment.
Median enrollment 120 across the 18 interventional studies, 120 across the 1 observational. Of the 13 that completed or were terminated, 5 (38%) have results posted.
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None of the 19 has an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 2 studies filed under Empowerment — fewer than ten, so there is no comparison to draw.
1 of the studies in Empowerment with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06848361Ann-Marie RoslandHelping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management | 2026-12 |
Among the 19 studies in Empowerment with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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
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.
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
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
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
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
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
| Milestone | Personalized Online Intervention | Online Usual Care or Standard Online Safety Information | WeWomen Plus Text Messaging Only | WeWomen Plus Text Messaging and Phone |
|---|---|---|---|---|
| Started | 660 | 605 | 0 | 0 |
| Completed | 618 | 573 | 0 | 0 |
| Not completed | 42 | 32 | 0 | 0 |
| Milestone | Personalized Online Intervention | Online Usual Care or Standard Online Safety Information | WeWomen Plus Text Messaging Only | WeWomen Plus Text Messaging and Phone |
|---|---|---|---|---|
| Started | 0 | 0 | 183 | 183 |
| Completed | 0 | 0 | 165 | 156 |
| Not completed | 0 | 0 | 18 | 27 |
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).
| score on a scale | Personalized Online Intervention | Online Usual Care or Standard Online Safety Information | WeWomen Plus Text Messaging Only | WeWomen 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 ± 20.81 | 0.03 ± 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 |
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).
| score on a scale | Personalized Online Intervention | Online Usual Care or Standard Online Safety Information | WeWomen Plus Text Messaging Only | WeWomen Plus Text Messaging and Phone |
|---|---|---|---|---|
| 1-3 months | -0.41 ± 5.32 | -0.35 ± 5.23 | 0.83 ± 5.35 | 0.03 ± 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 |
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).
| score on a scale | Personalized Online Intervention | Online Usual Care or Standard Online Safety Information | WeWomen Plus Text Messaging Only | WeWomen Plus Text Messaging and Phone |
|---|---|---|---|---|
| 1-3 months | -0.10 ± 0.75 | -0.11 ± 0.76 | 0.01 ± 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 |
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).
| score on a scale | Personalized Online Intervention | Online Usual Care or Standard Online Safety Information | WeWomen Plus Text Messaging Only | WeWomen Plus Text Messaging and Phone |
|---|---|---|---|---|
| 1-3 months | 0.42 ± 16.30 | 0.66 ± 16.76 | -3.16 ± 15.89 | -5.10 ± 15.92 |
| 3-6 months | 1.20 ± 16.01 | 1.20 ± 15.73 | 2.74 ± 16.20 | 5.35 ± 16.71 |
| 1-6 months | 1.20 ± 17.81 | 1.81 ± 17.41 | -0.39 ± 16.23 | -0.05 ± 16.63 |
| 3-12 months | 1.46 ± 17.80 | -0.53 ± 16.62 | 2.59 ± 15.47 | 3.75 ± 16.85 |
| 1-12 months | 1.25 ± 20.52 | 0.33 ± 18.25 | -0.84 ± 17.09 | -1.35 ± 17.66 |
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).
| score on a scale | Personalized Online Intervention | Online Usual Care or Standard Online Safety Information | WeWomen Plus Text Messaging Only | WeWomen Plus Text Messaging and Phone |
|---|---|---|---|---|
| 1-3 months | 0.16 ± 0.71 | 0.10 ± 0.69 | -0.40 ± 0.45 | -0.39 ± 0.45 |
| 3-6 months | -0.10 ± 0.70 | -0.06 ± 0.72 | 0.35 ± 0.64 | 0.29 ± 0.64 |
| 1-6 months | 0.08 ± 0.63 | 0.04 ± 0.65 | -0.04 ± 0.61 | -0.10 ± 0.63 |
| 3-12 months | -0.09 ± 0.70 | -0.09 ± 0.72 | 0.34 ± 0.63 | 0.24 ± 0.58 |
| 1-12 months | 0.07 ± 0.68 | 0.02 ± 0.71 | -0.07 ± 0.54 | -0.16 ± 0.66 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personalized Online Intervention | 0/660 (0%) | 0/660 (0%) | 0/660 (0%) |
| Online Usual Care or Standard Online Safety Information | 0/605 (0%) | 0/605 (0%) | 0/605 (0%) |
| WeWomen Plus Text Messaging Only | 0/183 (0%) | 0/183 (0%) | 0/183 (0%) |
| WeWomen Plus Text Messaging and Phone | 0/183 (0%) | 0/183 (0%) | 0/183 (0%) |
| Age, Categorical(Participants) | Personalized Online Intervention | Standard Online Safety Information | Total |
|---|---|---|---|
| <=18 years | 8 | 6 | 14 |
| Between 18 and 65 years | 652 | 599 | 1251 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Personalized Online Intervention | Standard Online Safety Information | Total |
|---|---|---|---|
| Mean | 36.70 ± 9.88 | 37.39 ± 9.67 | 37.00 ± 9.80 |
| Sex: Female, Male(Participants) | Personalized Online Intervention | Standard Online Safety Information | Total |
|---|---|---|---|
| Female | 660 | 605 | 1265 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Personalized Online Intervention | Standard Online Safety Information | Total |
|---|---|---|---|
| Hispanic or Latino | 255 | 269 | 524 |
| Not Hispanic or Latino | 396 | 330 | 726 |
| Unknown or Not Reported | 9 | 6 | 15 |
| Race (NIH/OMB)(Participants) | Personalized Online Intervention | Standard Online Safety Information | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 5 | 8 |
| Asian | 222 | 164 | 386 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Black or African American | 85 | 87 | 172 |
| White | 167 | 189 | 356 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 181 | 159 | 340 |
| Physical and Sexual IPV(units on a scale) | Personalized Online Intervention | Standard Online Safety Information | Total |
|---|---|---|---|
| Mean | 18.03 ± 25.52 | 17.83 ± 25.07 | 17.94 ± 25.29 |
| Depression(units on a scale) | Personalized Online Intervention | Standard Online Safety Information | Total |
|---|---|---|---|
| Mean | 9.98 ± 6.39 | 10.39 ± 6.61 | 10.18 ± 6.50 |
| Post-traumatic Stress Disorder (PTSD)(units on a scale) | Personalized Online Intervention | Standard Online Safety Information | Total |
|---|---|---|---|
| Mean | 2.42 ± 0.93 | 2.50 ± 1 | 2.46 ± 0.96 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2021 to primary completion in Jul 2024, 42 months.
Results were first posted in Jun 2025, 10 months after primary completion.
Of 82 non-industry interventional studies with no phase under Empowerment, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 42 months is above that.
Counting every sponsor, half of 82 studies reached it within 22 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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