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OpenTrials
Completed

NCT Number: NCT04163549

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.

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Key information

Conditions

Family Functioning Child Abuse Domestic Violence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Rescue Committee

New York, 10168, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAFE at Home

Behavioral

Discussion-based intervention

Primary outcomes

  1. 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

  1. Intimate partner violence

    Time frame: Three months after intervention completion

    Frequency change of past three month women's report of physical and/or sexual and/or emotional IPV (will also examine separately)

  2. Harsh discipline

    Time frame: Three months after intervention completion

    Frequency change of past three month report of men's and women's physical or psychological harsh discipline practices against index child

Sponsors and collaborators

Lead sponsor

International Rescue Committee

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2019
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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