Evaluating the Effectiveness of the Safe at Home Program

NCT04163549 | Completed

• 1 other identifier: Safe at Home
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of the pilot RCT examining the potential effectiveness of the Safe at Home program in DRC are to:

1. 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. 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.

Conditions

Family Functioning; Domestic Violence; Child Abuse

Outcome Measures

Primary Outcomes (1)

• Family functioning

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

  Three months after intervention completion

Secondary Outcomes (2)

• Intimate partner violence

  Three months after intervention completion

• Harsh discipline

  Three months after intervention completion

Study Arms (2)

Safe at Home Cycle 1

EXPERIMENTAL

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

Safe at Home Cycle 2

NO INTERVENTION

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.

Interventions

Safe at Home BEHAVIORAL

Discussion-based intervention

Safe at Home Cycle 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 18 years of age
• being of a polygamous household
• not registered for program
• obvious mental, or cognitive, or communication difficulties.

Sponsors & Collaborators

• International Rescue Committee: lead

Study Sites (1)

International Rescue Committee

New York, New York, 10168, United States

Location

Related Publications (1)

• Falb KL, Asghar K, Blackwell A, Baseme S, Nyanguba M, Roth D, Hategekimana JD. Improving family functioning and reducing violence in the home in North Kivu, Democratic Republic of Congo: a pilot cluster-randomised controlled trial of Safe at Home. BMJ Open. 2023 Mar 6;13(3):e065759. doi: 10.1136/bmjopen-2022-065759.

  PMID: 36878658 DERIVED

Study Officials

• Kathryn Falb

  International Rescue Committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 14, 2019
• Study Start: November 19, 2019
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: July 22, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)