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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD013863-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Bushra Sabri | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34711182 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 10.1186/s12889-021-11930-2 | Study Protocol | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. WeWomen Plus technology-based intervention: The WeWomen Plus intervention is a technology-based (online, text, and phone) intervention designed to reduce the risk of future intimate partner violence or homicide, improve mental health, and increase the empowerment of abused women. |
| FG001 | Online Usual Care or Standard Online Safety Information | Women in the Standard Online Safety Information condition 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. |
| FG002 | WeWomen Plus Text Messaging Only | For second stage randomization, the text messaging intervention followed-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 personalized online intervention or non-tailored (standard list of resources) safety recommendations provided in the usual care or standard online safety information arm. WeWomen Plus technology-based intervention: The WeWomen Plus intervention is a technology-based (online, text, and phone) intervention designed to reduce the risk of future intimate partner violence or homicide, improve mental health, and increase empowerment of abused women. |
| FG003 | WeWomen Plus Text Messaging and Phone | Second-stage randomization involved both text and phone calls for non-responder groups of women in personalized online or standard online safety information 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 WeWomen Plus technology-based intervention: The WeWomen Plus intervention is a technology-based (online, text, and phone) intervention designed to reduce the risk of future intimate partner violence or homicide, improve mental health, and increase empowerment of abused women. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Stage Randomization |
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| Second Stage Re-Randomization |
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| ID | Title | Description |
|---|---|---|
| BG000 | Personalized Online Intervention | Women received the culturally adapted myPlan intervention, a web-based safety decision-making tool based on Dutton's empowerment model with danger assessment and tailored safety planning. |
| BG001 | Standard Online Safety Information |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline (1st month), 3 months, 6 months, 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. WeWomen Plus technology-based intervention: The WeWomen Plus intervention is a technology-based (online, text, and phone) intervention designed to reduce the risk of future intimate partner violence or homicide, improve mental health, and increase the empowerment of abused women. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bushra Sabri | Johns Hopkins University | +1 (410) 955-7105 | bsabri1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2025 | May 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003075 | Coitus |
| D000079102 | Empowerment |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D010549 | Personal Satisfaction |
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The study used a sequential, multiple assignment, randomized (SMART) design
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|
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| 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). | 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). | 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). | Baseline, 3 months, 6 months, 12 months |
| COMPLETED |
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| NOT COMPLETED |
|
Women received usual safety planning resources modeled on national and state domestic violence online resources without danger assessment-informed safety planning. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Physical and Sexual IPV | Physical and sexual intimate partner violence (IPV) was measured using the adapted version of the Revised Conflict Tactics Scale (CTS2), with response categories ranging from 0=never to 4=very frequently. Total score ranged from 0-164, with higher scores indicating greater frequency and severity of intimate partner violence experiences. | Mean | Standard Deviation | units on a scale |
|
| Depression | Depressive symptoms were measured using The Patient Health Questionnaire (PHQ-9), a nine-item measure. Each of the nine items scored from 0 (not at all) to 3 (nearly every day). Total scores ranged from 0 to 27, with higher scores indicating more severe depression symptoms. A score of 10 or above indicates clinically significant depression symptoms. | Mean | Standard Deviation | units on a scale |
|
| Post-traumatic Stress Disorder (PTSD) | Past week PTSD symptoms were measured using the Harvard Trauma Questionnaire (16 items), with response options ranging from 1 (Not at all) to 5 (Extremely) per item. The mean of the participant scale choices (1-5) across all 16 items is reported. Higher scores indicated more severe PTSD symptoms, with score greater than 2.5 indicating clinically significant PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Overall Empowerment | The Personal Progress Scale-Revised (PPS-R) (23 items) was used to assess multiple areas associated with overall empowerment. The responses were rated on a 7-point scale ranging from 1 (almost Never) to 7 (almost Always). The scores ranged from 23 to 161. Higher scores indicated a higher level of empowerment. | Mean | Standard Deviation | units on a scale |
|
| Safety-Related Empowerment | The MOVERS, a 13-item scale, was used to measure empowerment within the domain of safety. Participants responded to each item using a five-point scale, ranging from "1 = never true" to "5 = always true". The mean of the participant scale choices (1-5) across all 13 items is reported. Higher scores indicated a greater degree of safety-related empowerment. | Mean | Standard Deviation | units on a scale |
|
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. 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. |
| OG001 | 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. |
| OG002 | 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 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. |
| OG003 | 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 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. |
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 12 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 12 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 12 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 12 months |
|
|
|
| 0 |
| 660 |
| 0 |
| 660 |
| 0 |
| 660 |
| EG001 | Online Usual Care or Standard Online Safety Information | Women in the Standard Online Safety Information condition 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. | 0 | 605 | 0 | 605 | 0 | 605 |
| EG002 | WeWomen Plus Text Messaging Only | For second stage randomization, the text messaging intervention followed-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 personalized online intervention or non-tailored (standard list of resources) safety recommendations provided in the usual care or standard online safety information arm. WeWomen Plus technology-based intervention: The WeWomen Plus intervention is a technology-based (online, text, and phone) intervention designed to reduce the risk of future intimate partner violence or homicide, improve mental health, and increase empowerment of abused women. | 0 | 183 | 0 | 183 | 0 | 183 |
| EG003 | WeWomen Plus Text Messaging and Phone | Second-stage randomization involved both text and phone calls for non-responder groups of women in personalized online or standard online safety information 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 WeWomen Plus technology-based intervention: The WeWomen Plus intervention is a technology-based (online, text, and phone) intervention designed to reduce the risk of future intimate partner violence or homicide, improve mental health, and increase empowerment of abused women. | 0 | 183 | 0 | 183 | 0 | 183 |
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| 1-6 months |
|
| 3-6 months |
|
| 3-12 months |
|
| 1-12 months |
|
| 3-6 months |
|
| 1-6 months |
|
| 3-12 months |
|
| 1-12 months |
|
| 3-6 months |
|
| 1-6 months |
|
| 3-12 months |
|
| 1-12 months |
|
| 3-6 months |
|
| 1-6 months |
|
| 3-12 months |
|
| 1-12 months |
|