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Completed

NCT Number: NCT04098276

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: IWWP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2019
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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