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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05515094
Other study ID # DF222
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2023
Est. completion date December 31, 2023

Study information

Verified date August 2022
Source International Rescue Committee
Contact Kathryn Falb
Phone (202) 822-0043
Email kathryn.falb@rescue.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Empowerment Counseling Intervention
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
International Rescue Committee George Washington University, World Health Organization

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Checklist of Safety Behaviors 12 item index of safety behaviors; increased number of safety behaviors indicates improvement in safety behaviors Through study completion, average length three months;
Secondary Uptake of case management services 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. Through study completion, average length three months;
Secondary Intimate Partner violence- Proportion of women indicating they have experienced physical, sexual, and / or psychological IPV using the WHO multi-country study instruments on IPV Through study completion, average length three months;
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