Women and Child, Safety, Health, and Empowerment (WC-SHE)

December 7, 2023 updated by: Johns Hopkins University

Integrating Maternal, Fetal, Newborn or Infant Safety in Antenatal and Post-natal Care Services for Rural and Tribal Women in India

Gender-based violence (GBV) (including homicide) is one of the leading causes of maternal and child (fetus, newborn or infant) mortality and morbidity in limited resource settings such as India. This study is evaluating the feasibility, acceptability and preliminary efficacy of WC-SHE (Women and Children-Safety, Health and Empowerment) intervention developed to promote health and safety outcomes of mother and children in rural and/or tribal regions in India. The aim will be to refine, optimize and standardize the WC-SHE intervention and its added components, develop fidelity measures, conduct a feasibility and acceptability evaluation of the intervention and implementation procedures as well as examine preliminary efficacy outcomes of WC-SHE.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Over 18 years of age
  2. Currently pregnant
  3. Experienced intimate partner and/or in-law abuse in the past
  4. Residing in rural or tribal areas in India

Exclusion Criteria:

  1. Under 18 years of age
  2. Not currently pregnant
  3. No experience of intimate partner and/or in law abuse
  4. Not residing in rural or tribal areas in India

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Web-based Intervention Arm (WC-SHE)
Women in computerized WC-SHE arm receives education on healthy relationships the danger assessment and tailored safety planning and list of resources. The intervention also includes assessments of strengths and safety strategies. In addition, husbands and in-laws receive one-on-one health education session that includes topics related to maternal and child health and safety
Behavioral: Women and Child, Safety, Health and Empowerment (WC-SHE)
The WC-SHE component includes a risk assessment and tailored safety planning for women in domestic violence relationships. In addition, the component involves one-on-one education with husbands and in-laws. The economic empowerment component is designed to support women and their husbands in economic empowerment activities. The advocacy arm involves community education of husbands and in-laws, advocacy support by a support committee comprised of multidisciplinary professionals and phone support by women community resource persons
Experimental: WC-SHE +Economic Empowerment
Women in economic empowerment arm receive computerized WC-SHE and are connected with self-help groups. Husbands are also engaged in economic empowerment activities that involve individual psychoeducation, working with spouses in self-help group activities and participating in government economic or vocational training programs. In addition, husbands and in-laws participate in individual sessions on topics related to maternal and child health and safety
Behavioral: Women and Child, Safety, Health and Empowerment (WC-SHE)
The WC-SHE component includes a risk assessment and tailored safety planning for women in domestic violence relationships. In addition, the component involves one-on-one education with husbands and in-laws. The economic empowerment component is designed to support women and their husbands in economic empowerment activities. The advocacy arm involves community education of husbands and in-laws, advocacy support by a support committee comprised of multidisciplinary professionals and phone support by women community resource persons
Experimental: WC-SHE + Enhanced Family Psychoeducation and Advocacy Support Intervention
Women in this arm receive computerized WC-SHE, advocacy and support by a support committee of professionals based on women's priorities and needs, and phone call support by women community resource persons. Husbands and in-laws participate in individual and group sessions that cover topics such as stress, healthy relationships, healthy communication within families and impact of domestic violence on children.
Behavioral: Women and Child, Safety, Health and Empowerment (WC-SHE)
The WC-SHE component includes a risk assessment and tailored safety planning for women in domestic violence relationships. In addition, the component involves one-on-one education with husbands and in-laws. The economic empowerment component is designed to support women and their husbands in economic empowerment activities. The advocacy arm involves community education of husbands and in-laws, advocacy support by a support committee comprised of multidisciplinary professionals and phone support by women community resource persons

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fetal safety as measured by occurrence of fetal loss
Time Frame: Post intervention up to 6 months
Fetal loss includes post-intervention occurrence of any induced abortion or miscarriage, spontaneous abortion or miscarriage, or occurrence of fetal mortality or still birth
Post intervention up to 6 months
Newborn/infant safety as measured by self-reported items developed by the study team
Time Frame: 6 months
The following items are used to measure newborn or infant safety, (a) participants are asked about concern for the child's mistreatment by the participants husband or in-laws. The response options range from never (0) to always (4). (b) Participants are asked if there is concern about harm to the child by anyone, with yes/no response options; Any incident of death of a child within few weeks post-delivery is based on participants' self-reports
6 months
Newborn/infant health as measured by two items developed by the study team
Time Frame: 6 months
Newborn/infant health is measured by number of participants who delivered a low birth weight or pre-term child. Participants are asked if newborn was (a) a low birthweight child; and (b) child born preterm.
6 months
Severity and frequency of abuse by husband and in-laws as measured by the adapted Conflict Tactics Scale (CTS2)
Time Frame: Baseline, 3 months, 6 months
Severity and frequency of abuse is assessed by the adapted version of the Revised Conflict Tactics Scale . Response categories range from 0 (never) to very 7 (frequently). Higher overall scores mean more conflict. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Number of maternal safety behaviors as assessed by the Safety Behavior Checklist
Time Frame: Baseline, 3 months, 6 months
The Safety Behavior Checklist is used to measure the number of safety strategies and support services used. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Victim empowerment related to safety as assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) Scale
Time Frame: Baseline, 3 months, 6 months
The MOVERS scale is a 13 item scale that measures survivor empowerment within the domain of safety. Participants respond to each item using a five-point Likert scale (from "never true" to "always true. Possible score range 13-65. Higher scores indicate higher levels of empowerment related to safety. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Uncertainty in choosing safety options as assessed by the Adapted Decisional Conflict scale
Time Frame: Baseline, 3 months, 6 months
The Adapted decisional conflict scale is used to measure decisional conflict for safety. The response options ranged from strongly disagree to strongly agree, with higher scores indicating lower decisional conflict. Decisional Conflict Scale scores range from 0(no decisional conflict) to 100 (high decisional conflict). Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Depression as assessed by the Patient Health Questionnaire
Time Frame: Baseline, 3 months, 6 months
The Patient Health Questionnaire (PHQ-9) is used to measure depression; Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression. Score range 0-27. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Probable Post Traumatic Stress Disorder (PTSD) in primary care settings
Time Frame: Baseline, 3 months, 6 months
Primary Care PTSD Screen is a 5 item screen used to identify participants with probable PTSD in primary care settings. The items are rated on a binary scale (No, Yes). Score range 1-5. Higher scores indicate increased post traumatic stress symptoms. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Physical health status
Time Frame: Baseline, 3 months, 6 months
For self-rated physical health, participants are asked about how would they describe their health during pregnancy (or post-delivery). The response options include poor, fair and excellent with poor coded as 1, fair as 2 and excellent as 3. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Level of satisfaction with child's health and health-related issues as assessed by the Postpartum Quality of Life (PQOL) measure
Time Frame: 6 months
Participants are asked adapted items from the child care dimension of the Postpartum Quality of Life (PQOL) measure. The response options for items range from very dissatisfied to very satisfied and frequency levels ranging from never to always. Score range 16-80, with higher scores showing better quality of life.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-efficacy for safety as assessed by an item developed by study team
Time Frame: Baseline, 3 months, 6 months
Self-efficacy for safety is measured using one item that assesses for the level of confidence women have in their ability to implement measures to keep themselves safe from experiencing abuse and mistreatment. The response options range from not confident at all to very confident. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Resilience as assessed by the Connor Davidson Resilience Scale
Time Frame: Baseline, 3 and 6 months
Resilience is measured using the 10-item Connor-Davidson Resilience Scale; Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4.
Baseline, 3 and 6 months
Sources of support as assessed by the Brief Perceived Social Support Questionnaire
Time Frame: Baseline, 3 months, 6 months
Perceived sources of support are measured using the Brief Perceived Social Support. The questionnaire.measures general perceived social support with a 6 item, five-point Likert scale ranging from 1 (not true at all) to 5 (very true). Higher scores indicate higher levels of perceived social support. Possible score 6-30. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Number of Self- care behaviors as measured by the items developed by the study team
Time Frame: Baseline, 3 months, 6 months
Women are asked about the number of care visits and visits to healthcare providers for specific health concerns. Change in self care behaviors will be assessed by change in attending the minimum number of recommended care visits; and number of visits to medical providers for health concerns. Measured at Baseline, 3 months, 6 months.
Baseline, 3 months, 6 months
Economic stress
Time Frame: Baseline, 3 months, 6 months

Participants are asked about how often they ran out of money for necessities (e.g., food, housing etc for themselves or/and their children). The response options include never, once or twice, every month or monthly, every week or weekly, every day or daily. Measured at Baseline, 3 months, 6 months.

.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bushra Sabri, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00278599

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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