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Clinical Trials/NCT04163549
NCT04163549
Completed
Not Applicable

Evaluating the Effectiveness of the Safe at Home Program

International Rescue Committee1 site in 1 country404 target enrollmentStarted: November 19, 2019Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
404
Locations
1
Primary Endpoint
Family functioning

Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Family functioning

Time Frame: Three months after intervention completion

Mean change in women's reports (primary) and men's reports of family functioning

Secondary Outcomes

  • Intimate partner violence(Three months after intervention completion)
  • Harsh discipline(Three months after intervention completion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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