Family FunctioningNCT04163549
Evaluating the Effectiveness of the Safe at Home Program
A study testing Safe at Home in people with Family Functioning and Domestic Violence, run by International Rescue Committee at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Functioning, Domestic Violence, Child Abuse
- What is being tested?
- Safe at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 18 years of age
- being of a polygamous household
- not registered for program
- obvious mental, or cognitive, or communication difficulties.
Trial locations and contacts
1 site in 1 country.
United States1 site
International Rescue Committee
New York, New York, 10168
About this study
The goals of the pilot RCT examining the potential effectiveness of the Safe at Home program in DRC are to:
- 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
- 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.
Read the 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.
- Conditions
- Family Functioning, Domestic Violence, Child Abuse
- Being tested
- Safe at Home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe at HomeBehavioural
Discussion-based intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family functioning
Mean change in women's reports (primary) and men's reports of family functioning
Measured: Three months after intervention completion
Secondary outcomes (2)
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)
Measured: 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
Measured: Three months after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start19 Nov 2019
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family FunctioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Rescue Committee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Falb, Principal investigator, International Rescue Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163549
- Sponsor's protocol ID
- Safe at Home
- Status last verified
- Oct 2021
- First submitted
- 12 Nov 2019
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36878658
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of the Safe at Home Program
- ClinicalTrials.gov ID
- NCT04163549
- Acronym / sponsor ID
- Safe at Home
- Conditions
- Family Functioning, Domestic Violence, Child Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- International Rescue CommitteeUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of the pilot RCT examining the potential effectiveness of the Safe at Home program in DRC are to:
- 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
- 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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe at Home Cycle 1 | Experimental | Behavioral: Safe at HomeThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- < 18 years of age
- being of a polygamous household
- not registered for program
- obvious mental, or cognitive, or communication difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe at HomeDiscussion-based intervention | Behavioural | Safe at Home Cycle 1 |
Primary outcome
Family functioning
Time frame: Three months after intervention completion
Mean change in women's reports (primary) and men's reports of family functioning
2 secondary outcomes
Intimate partner violence
Time frame: Three months after intervention completion
Harsh discipline
Time frame: Three months after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 36878658Falb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Falb principal investigator
International Rescue Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe at Home in people with Family Functioning and Domestic Violence, run by International Rescue Committee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family functioning (time frame: Three months after intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04163549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.