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Behavioral Intervention

WC-SHE for Gender-Based Violence (WC-SHE Trial)

N/A

Waitlist Available

Led By Bushra Sabri, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 and 6 months

Awards & highlights

WC-SHE Trial Summary

This trial is evaluating an intervention to improve maternal & child health & safety, and empower women in rural India. They'll refine, optimize & standardize the intervention & its components, evaluate its feasibility & acceptability & measure preliminary efficacy outcomes.

Who is the study for?

This trial is for women over 18 who are currently pregnant and have experienced intimate partner or in-law abuse. They must live in rural or tribal areas of India. It's not open to those under 18, not pregnant, living outside these regions, or without such abuse experiences.Check my eligibility

What is being tested?

The study tests the WC-SHE program designed to improve health and safety for mothers and children facing gender-based violence in India. It aims to assess how well the program works, if it's acceptable to participants, and its initial effectiveness.See study design

What are the potential side effects?

Since this intervention involves social support rather than medical treatment, traditional side effects aren't expected. However, participants may experience emotional distress or discomfort when discussing sensitive topics like personal experiences with violence.

WC-SHE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Depression as assessed by the Patient Health Questionnaire

Fetal safety as measured by occurrence of fetal loss

Level of satisfaction with child's health and health-related issues as assessed by the Postpartum Quality of Life (PQOL) measure

+8 more

Secondary outcome measures

Economic stress

Number of Self- care behaviors as measured by the items developed by the study team

Resilience as assessed by the Connor Davidson Resilience Scale

+2 more

WC-SHE Trial Design

3Treatment groups

Experimental Treatment

Group I: Web-based Intervention Arm (WC-SHE)Experimental Treatment1 Intervention

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 II: WC-SHE +Economic EmpowermentExperimental Treatment1 Intervention

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 III: WC-SHE + Enhanced Family Psychoeducation and Advocacy Support InterventionExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2022

N/A

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,819,921 Total Patients Enrolled

Bushra Sabri, PhDPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

144 Total Patients Enrolled

Media Library

Women and Child, Safety, Health and Empowerment (WC-SHE) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05940129 — N/A

Gender-Based Violence Research Study Groups: Web-based Intervention Arm (WC-SHE), WC-SHE +Economic Empowerment, WC-SHE + Enhanced Family Psychoeducation and Advocacy Support Intervention

Gender-Based Violence Clinical Trial 2023: Women and Child, Safety, Health and Empowerment (WC-SHE) Highlights & Side Effects. Trial Name: NCT05940129 — N/A

Women and Child, Safety, Health and Empowerment (WC-SHE) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05940129 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial presently accepting new participants?

"The clinical trial is presently recruiting, with the original post date being October 21st 2022 and most recent update on June 30th 2023. This information can be verified on clinicialtrials.gov."

Answered by AI

What is the aggregate participant count for this trial?

"Affirmative. According to clinicaltrials.gov, this investigation was initially published on October 21st 2022 and has recently been updated as of June 30th 2023. 150 participants are needed from a single site for the trial's completion."

Answered by AI

What are the predicted results of this experiment?

"The primary outcome of this research, which is evaluated over a Baseline-3 Months-6 Month timeline, looks to measure the Change in Victim Empowerment Related to Safety (MOVERS) Scale. Other secondary outcomes include changes in Perceived Social Support as assessed by the Brief Perceived Social Support Questionnaire; self-care behaviors tracked via metrics created by the study team; and Resilience recorded with the Connor Davidson Resilience Scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Women and Child, Safety, Health, and Empowerment

2022. "Women and Child, Safety, Health, and Empowerment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05940129.