Clinical trial NCT05940129: Women and Child, Safety, Health, and Empowerment
Official title: Integrating Maternal, Fetal, Newborn or Infant Safety in Antenatal and Post-natal Care Services for Rural and Tribal Women in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender-based Violence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity and frequency of abuse by husband and in-laws as measured by the adapted Conflict Tactics Scale (CTS2)
timeFrame: Baseline, 3 months, 6 months
measure: Number of maternal safety behaviors as assessed by the Safety Behavior Checklist
timeFrame: Baseline, 3 months, 6 months
measure: Victim empowerment related to safety as assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) Scale
timeFrame: Baseline, 3 months, 6 months
measure: Uncertainty in choosing safety options as assessed by the Adapted Decisional Conflict scale
timeFrame: Baseline, 3 months, 6 months
measure: Depression as assessed by the Patient Health Questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Probable Post Traumatic Stress Disorder (PTSD) in primary care settings
timeFrame: Baseline, 3 months, 6 months
measure: Physical health status
timeFrame: Baseline, 3 months, 6 months
measure: Fetal safety as measured by occurrence of fetal loss
timeFrame: Post intervention up to 6 months
measure: Newborn/infant safety as measured by self-reported items developed by the study team
timeFrame: 6 months
measure: Newborn/infant health as measured by two items developed by the study team
timeFrame: 6 months
measure: Level of satisfaction with child's health and health-related issues as assessed by the Postpartum Quality of Life (PQOL) measure
timeFrame: 6 months
Secondary outcomes:
measure: Self-efficacy for safety as assessed by an item developed by study team
timeFrame: Baseline, 3 months, 6 months
measure: Resilience as assessed by the Connor Davidson Resilience Scale
timeFrame: Baseline, 3 and 6 months
measure: Sources of support as assessed by the Brief Perceived Social Support Questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Number of Self- care behaviors as measured by the items developed by the study team
timeFrame: Baseline, 3 months, 6 months
measure: Economic stress
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Bushra Sabri, PhD
role: PRINCIPAL_INVESTIGATOR
References: