Evaluating the Effectiveness of the Safe at Home Program

NCT ID: NCT04163549

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2021-09-20

Brief Summary

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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

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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.

Conditions

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Family Functioning Domestic Violence Child Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Safe at Home

Intervention Type BEHAVIORAL

Discussion-based 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Safe at Home

Discussion-based intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Rescue Committee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Falb

Role: PRINCIPAL_INVESTIGATOR

International Rescue Committee

Locations

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International Rescue Committee

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36878658 (View on PubMed)

Other Identifiers

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Safe at Home

Identifier Type: -

Identifier Source: org_study_id

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