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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04163549
Other study ID # Safe at Home
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2019
Est. completion date September 20, 2021

Study information

Verified date October 2021
Source International Rescue Committee
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goals of the pilot RCT examining the potential effectiveness of the Safe at Home program in DRC are to: 1. Determine the potential effectiveness of Safe at Home program on improvements of family functioning and secondary outcomes of reductions in intimate partner violence and child maltreatment 2. Determine the potential effectiveness of the Safe at Home program on changes in pathway outcomes such as attitudes towards harsh discipline, gender attitudes, power-sharing, positive parenting practices, etc.


Description:

For the pilot RTC, quantitative data will be collected from up to 420 individuals participating in the Safe at Home program in the North Kivu, DRC. The 420 individuals comprising the study population will be 210 couples, of which both the male and female partners will be asked to participate in the study. After baseline data collection is completed, within each of the four sites where the program will occur in North Kivu, DRC, two groups of couples will be formed (n=8 groups total). Each group will be formed based on geographical proximity and will mirror real-life implementation of the program and ensure high fidelity to program design and limit contamination or spillover of Safe at Home to the control groups. Groups will then be randomized to receive Safe at Home in Cycle 1 or be waitlisted to receive Safe at Home in Cycle 2. After randomization is completed the Cycle 1 programming will commence. Following a waiting period of 3 months after the program ends, the endline survey will be administered. Subsequently Cycle 2 cohort will receive programming.


Recruitment information / eligibility

Status Completed
Enrollment 404
Est. completion date September 20, 2021
Est. primary completion date September 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - registered for the Safe at Home program - living with intimate partner who is also registered for the program and at least one child aged 6-12 - speaker of Swahili, Kinyarwanda, or French Exclusion criteria includes: - < 18 years of age - being of a polygamous household - not registered for program - obvious mental, or cognitive, or communication difficulties.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Safe at Home
Discussion-based intervention

Locations

Country Name City State
United States International Rescue Committee New York New York

Sponsors (1)

Lead Sponsor Collaborator
International Rescue Committee

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Family functioning Mean change in women's reports (primary) and men's reports of family functioning Three months after intervention completion
Secondary Intimate partner violence Frequency change of past three month women's report of physical and/or sexual and/or emotional IPV (will also examine separately) Three months after intervention completion
Secondary Harsh discipline Frequency change of past three month report of men's and women's physical or psychological harsh discipline practices against index child Three months after intervention completion
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