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Strengthening Women's Agency During Pregnancy

Not Applicable
Conditions
Intimate Partner Violence
Interventions
Behavioral: Empowerment Counseling Intervention
Registration Number
NCT05515094
Lead Sponsor
International Rescue Committee
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.

Detailed Description

This research aims to address the feasibility and acceptability of a brief empowerment counseling intervention (ECI) among pregnant women and girls receiving antenatal care (ANC) who have experienced intimate partner violence (IPV), in humanitarian healthcare settings. This 3- year study will take place in two IRC-managed health posts in a refugee camp in Kigoma, Tanzania. The objectives of the study are to: 1) Adapt, as needed, for use in the context of ANC in a humanitarian setting, a brief ECI to address women's and girls' exposure to sexual and/or physical IPV during pregnancy, by improving their mental health, self-efficacy, safety, and coping strategies; 2) Test the ECI through a pilot randomized controlled trial, determining whether the intervention is feasible/acceptable and whether it improves women's self-efficacy, reduces mental distress and increases uptake of longer-term IPV services; 3) Test the feasibility of integrating such an intervention into pre-existing ANC service delivery in humanitarian settings and make recommendations for future intervention research and development, including effectively linking routine enquiry of IPV in ANC settings with support service use.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
150
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention Arm (Empowerment Counseling Intervention)Empowerment Counseling InterventionThe 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.
Primary Outcome Measures
NameTimeMethod
General Self-Efficacy Scale3 months endline survey, present recall period

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

Patient Health Questionnaire - 93 months endline survey, past two week recall period

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

Secondary Outcome Measures
NameTimeMethod
Intimate Partner violence-Through study completion, average length three months;

Proportion of women indicating they have experienced physical, sexual, and / or psychological IPV using the WHO multi-country study instruments on IPV

Checklist of Safety BehaviorsThrough study completion, average length three months;

12 item index of safety behaviors; increased number of safety behaviors indicates improvement in safety behaviors

Uptake of case management servicesThrough study completion, average length three months;

Two items indicating whether a survivor has shared information about violence with others or has sought additional services. Higher endorsement is better uptake of case management services.

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