Evaluating the Effectiveness of the Safe at Home Program

Domestic Violence Clinical Trial

Official title:

Evaluating the Effectiveness of the Safe at Home Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163549
• Other study ID #: Safe at Home
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Child Abuse
• Domestic Violence
• Family Functioning

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