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

Johns Hopkins University

Status: Completed

Conditions: Gender-based Violence

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05940129

IRB00278599

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 3 patient groups

Web-based Intervention Arm (WC-SHE)

Experimental group

Description:

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

Treatment:

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

WC-SHE +Economic Empowerment

Experimental group

Description:

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

Treatment:

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

WC-SHE + Enhanced Family Psychoeducation and Advocacy Support Intervention

Experimental group

Description:

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.

Treatment:

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