Evaluating the Effectiveness of the Safe at Home Program

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.

Study Overview

• Status: Completed
• Conditions: Child Abuse; Domestic Violence; Family Functioning
• Intervention / Treatment: Behavioral: Safe at Home

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 Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10168
      • International Rescue Committee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safe at Home Cycle 1; The experimental arm will receive the Safe at Home program which is a community-based discussion group series aiming to prevent and respond to intimate partner violence and child maltreatment in conflict-affected communities. It includes once weekly, single-sex discussion groups with coupled men and women and once monthly family discussion groups with couples and children. During the weekly sessions men and women reflect critically and engage in dialogue related to gender, power, and privilege, learn about the causes and consequence of violence against women and children and gain skills in stress management, psychosocial support and positive parenting strategies. Family sessions focus on improving relationship quality and shared decision-making among partners and participation of children in family decision-making.	Behavioral: Safe at Home; Discussion-based intervention
No Intervention: Safe at Home Cycle 2; During the period of the study, this group will not receive an intervention. Rather, this arm will receive the Safe at Home program after endline data collection is completed for a waitlisted group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family functioning	Mean change in women's reports (primary) and men's reports of family functioning	Three months after intervention completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: International Rescue Committee
• Investigators: Principal Investigator: Kathryn Falb, International Rescue Committee

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Safe at Home

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No