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Women and Child, Safety, Health, and Empowerment

NCT ID: NCT05940129

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-21

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gender-based Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bushra Sabri, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00278599

Identifier Type: -

Identifier Source: org_study_id