Strengthening Women's Agency During Pregnancy

NCT05515094 | Unknown

• 1 other identifier: DF222
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research aims to address the feasibility and acceptability of a brief empowerment counselling intervention (ECI) among pregnant women and girls receiving antenatal care (ANC) who have experienced intimate partner violence (IPV), in humanitarian healthcare settings.

Conditions

Intimate Partner Violence

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire - 9

  Depressive symptoms will be assessed via the PHQ-9 questionnaire. The range of scores is 0-27. A higher score indicates more symptoms.

  3 months endline survey, past two week recall period

• General Self-Efficacy Scale

  Adapted measure of the GSE Scale. Possible score 10-40; higher indicating more self-efficacy.

  3 months endline survey, present recall period

Secondary Outcomes (3)

• Checklist of Safety Behaviors

  Through study completion, average length three months;

• Uptake of case management services

  Through study completion, average length three months;

• Intimate Partner violence-

  Through study completion, average length three months;

Study Arms (2)

Intervention Arm (Empowerment Counseling Intervention)

EXPERIMENTAL

The Empowerment Counseling Intervention (ECI) entails directly linking women to on-site case managers who will provide first-line support (i.e., a brief psychosocial support session) and a safety and health assessment to women who are attending to receive ANC and disclose violence. The intervention (e.g., the initial counselling session), adapted from current case management guidelines and the Safe and Sound intervention at health facilities, will be administered directly at the health facility after a woman screens positive for IPV. In line with a survivor centered approach, as part of the initial session, the survivor participant will be invited back for further counselling sessions as part of the intervention curriculum, in addition to being supported to access other services based on her preferences, such as group psychosocial support. The intervention manual acts as a guide and support for trained social workers to support the unique needs of each survivor.

Behavioral: Empowerment Counseling Intervention

Standard of Care

NO INTERVENTION

Women in the comparison arm will receive the standard of care and be referred to support services at the nearby IRC Women's Protection and Empowerment (WPE) office.

Interventions

Empowerment Counseling Intervention BEHAVIORAL

The intervention entails case managers conducting first-line support (i.e., a brief psychosocial support session), and a safety and health assessment, adapted from current case management content and the Safe and Sound intervention.

Intervention Arm (Empowerment Counseling Intervention)

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women or girl aged 15 years or older:
• Pregnant (any trimester);
• Attending their 2nd or later ANC visit;
• Have experienced physical and/or sexual and/or severe psychological IPV in the past 12 months;
• Consent to participate.

You may not qualify if:

• At their first ANC visit or accompanied by their partner (or anyone else) at the ANC visit;
• Under age 15;
• Unable to provide informed consent/assent;
• Suicidal or at risk of severe violence or of being murdered; and/or
• In a high-risk situation or medically high risk.

Sponsors & Collaborators

• International Rescue Committee: lead
• World Health Organization: collaborator
• George Washington University: collaborator

Study Officials

• Claudia Garcia Moreno

  World Health Organization

  PRINCIPAL INVESTIGATOR

• Mary Ellsberg

  George Washington University

  PRINCIPAL INVESTIGATOR

• Bathsheba Mahenge

  International Rescue Committee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Falb

CONTACT

(202) 822-0043; kathryn.falb@rescue.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: August 25, 2022
• Study Start: January 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-08