Gender-based ViolenceWC-SHENCT05940129
Women and Child, Safety, Health, and Empowerment
A study testing Women and Child, Safety, Health and Empowerment (WC-SHE) in people with Gender-based Violence, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gender-based Violence
- What is being tested?
- Women and Child, Safety, Health and Empowerment (WC-SHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Currently pregnant
- Experienced intimate partner and/or in-law abuse in the past
- Residing in rural or tribal areas in India
Who cannot join
- Under 18 years of age
- Not currently pregnant
- No experience of intimate partner and/or in law abuse
- Not residing in rural or tribal areas in India
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gender-based Violence
- Being tested
- Women and Child, Safety, Health and Empowerment (WC-SHE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women and Child, Safety, Health and Empowerment (WC-SHE)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Web-based Intervention Arm (WC-SHE) | Experimental | 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 Receives: Behavioral: Women and Child, Safety, Health and Empowerment (WC-SHE) |
| WC-SHE +Economic Empowerment | Experimental | 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 Receives: Behavioral: Women and Child, Safety, Health and Empowerment (WC-SHE) |
| WC-SHE + Enhanced Family Psychoeducation and Advocacy Support Intervention | Experimental | 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. Receives: Behavioral: Women and Child, Safety, Health and Empowerment (WC-SHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and frequency of abuse by husband and in-laws as measured by the adapted Conflict Tactics Scale (CTS2)
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.
Measured: Baseline, 3 months, 6 months
Number of maternal safety behaviors as assessed by the Safety Behavior Checklist
The Safety Behavior Checklist is used to measure the number of safety strategies and support services used. Measured at Baseline, 3 months, 6 months.
Measured: Baseline, 3 months, 6 months
Victim empowerment related to safety as assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) Scale
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.
Measured: Baseline, 3 months, 6 months
Uncertainty in choosing safety options as assessed by the Adapted Decisional Conflict scale
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.
Measured: Baseline, 3 months, 6 months
Depression as assessed by the Patient Health Questionnaire
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.
Measured: Baseline, 3 months, 6 months
Probable Post Traumatic Stress Disorder (PTSD) in primary care settings
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.
Measured: Baseline, 3 months, 6 months
Physical health status
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.
Measured: Baseline, 3 months, 6 months
Fetal safety as measured by occurrence of fetal loss
Fetal loss includes post-intervention occurrence of any induced abortion or miscarriage, spontaneous abortion or miscarriage, or occurrence of fetal mortality or still birth
Measured: Post intervention up to 6 months
Newborn/infant safety as measured by self-reported items developed by the study team
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
Measured: 6 months
Newborn/infant health as measured by two items developed by the study team
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.
Measured: 6 months
Level of satisfaction with child's health and health-related issues as assessed by the Postpartum Quality of Life (PQOL) measure
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.
Measured: 6 months
Secondary outcomes (5)
Self-efficacy for safety as assessed by an item developed by study team
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.
Measured: Baseline, 3 months, 6 months
Resilience as assessed by the Connor Davidson Resilience Scale
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.
Measured: Baseline, 3 and 6 months
Sources of support as assessed by the Brief Perceived Social Support Questionnaire
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.
Measured: Baseline, 3 months, 6 months
Number of Self- care behaviors as measured by the items developed by the study team
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.
Measured: Baseline, 3 months, 6 months
Economic stress
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.
.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start21 Oct 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender-based ViolenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bushra Sabri, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940129
- Sponsor's protocol ID
- IRB00278599
- Acronym
- WC-SHE
- Status last verified
- Dec 2023
- First submitted
- 28 Jun 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Maternal, Fetal, Newborn or Infant Safety in Antenatal and Post-natal Care Services for Rural and Tribal Women in India
- ClinicalTrials.gov ID
- NCT05940129
- Acronym / sponsor ID
- WC-SHE / IRB00278599
- Conditions
- Gender-based Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Web-based Intervention Arm (WC-SHE) | Experimental | Behavioral: Women and Child, Safety, Health and Empowerment (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 |
| WC-SHE +Economic Empowerment | Experimental | Behavioral: Women and Child, Safety, Health and Empowerment (WC-SHE)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 |
| WC-SHE + Enhanced Family Psychoeducation and Advocacy Support Intervention | Experimental | Behavioral: Women and Child, Safety, Health and Empowerment (WC-SHE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age
- Currently pregnant
- Experienced intimate partner and/or in-law abuse in the past
- Residing in rural or tribal areas in India
Key exclusion criteria (4 listed)
- Under 18 years of age
- Not currently pregnant
- No experience of intimate partner and/or in law abuse
- Not residing in rural or tribal areas in India
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | WC-SHE + Enhanced Family Psychoeducation and Advocacy Support Intervention, WC-SHE +Economic Empowerment, Web-based Intervention Arm (WC-SHE) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.
5 secondary outcomes
Self-efficacy for safety as assessed by an item developed by study team
Time frame: Baseline, 3 months, 6 months
Resilience as assessed by the Connor Davidson Resilience Scale
Time frame: Baseline, 3 and 6 months
Sources of support as assessed by the Brief Perceived Social Support Questionnaire
Time frame: 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
Economic stress
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bushra Sabri, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women and Child, Safety, Health and Empowerment (WC-SHE) in people with Gender-based Violence, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.