- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07621705
Multifamily Healing Spaces for Family Resilience in Rwanda (MFHS-CRT)
The Effectiveness of Multi-Family Healing Spaces on Family Resilience and Mental Health Outcomes: A Multi-Site Cluster-Randomized Waitlist-Control Trial in Rwanda
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
MFHS is a group-based, trauma-informed, family-systems intervention developed for post-genocide Rwanda. It combines psychoeducation, structured dialogue, family communication and problem-solving exercises, parenting and couple-relational work, and youth voice and identity activities. The intervention was delivered in intergenerational, whole-family, parent-only, and youth-only formats. MFHS comprised 18 core 3-hour meeting occasions, with parent-only and youth-only sessions delivered in parallel, plus four planned follow-up sessions where relevant.
Participants were identified through a broader Rwanda societal-healing screening process. Screening was conducted at the individual level, but MFHS invitation occurred at the family level: if any screened individual met the MFHS family-communication criterion, that person's family was invited. The audited screening workbook contained 4,214 adult/community screening records. After referral/triage for severe clinical flags and other staged interventions, 839 screened individuals were staged to MFHS. At the cell level, 56 eligible cells had enough staged MFHS-screened individuals to form a group; those cells contained 794 staged MFHS-screened individuals. Twenty trial clusters were randomly selected from the eligible cells and then allocated to MFHS or waitlist control. The final baseline cohort included 319 family members in 20 clusters: 167 in MFHS clusters and 152 in waitlist-control clusters.
The primary manuscript analysis is a baseline-cohort intention-to-treat analysis. All baseline-assessed participants were retained in their final fielded cluster allocation. Missing endline outcomes for 36 participants were handled through multiple imputation. Effects were estimated with baseline-adjusted cluster-level Analysis of Covariance (ANCOVA) weighted by baseline cluster size, with complete-case and unweighted analyses retained as sensitivity checks.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Eastern Province
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Ngoma, Eastern Province, Rwanda
- Community and Health-Centre Settings, Ngoma District
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Nyagatare, Eastern Province, Rwanda
- Community and Health-Centre Settings, Nyagatare District
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Northern Province
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Ruhengeri, Northern Province, Rwanda
- Community and Health-Centre Settings, Musanze District
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Southern Province
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Nyamagabe, Southern Province, Rwanda
- Community and Health-Centre Settings, Nyamagabe District
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Western Province
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Nyabihu, Western Province, Rwanda
- Community and Health-Centre Settings, Nyabihu District
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Member of a family living in or connected to a selected MFHS-eligible cluster/cell in one of the five study districts in Rwanda.
- Aged 12 years or older.
- Family invited because at least one screened family member met the staged MFHS criterion for family communication difficulties after higher-priority clinical and individual mental-health triage.
- Able and willing to participate in baseline assessment and, if allocated to MFHS, family/group sessions.
- Written informed consent, assent, and/or caregiver permission obtained according to age and local ethics requirements.
Exclusion Criteria:
- Individuals with suicidality, psychosis, or severe substance-use flags were routed for clinical interview or hospital referral rather than MFHS as first-line allocation.
- Individuals meeting higher-priority individual mental-health criteria were routed to Resilience-Oriented Therapy before the MFHS screening stage.
- Individuals or families unable to provide consent/assent or safely participate in group family sessions were not enrolled.
- Remaining individuals with social-conflict indicators after earlier stages were routed to sociotherapy rather than MFHS.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Multifamily Healing Spaces
Clusters allocated to Multifamily Healing Spaces (MFHS) received the behavioral family intervention during the trial evaluation period.
MFHS was delivered to families in group formats using intergenerational, whole-family, parent-only, and youth-only sessions.
|
MFHS is a culturally adapted, group-based family intervention for genocide-affected communities in Rwanda.
It includes 18 core 3-hour meeting occasions in intergenerational, whole-family, parent-only, and youth-only formats.
Sessions focus on trauma-informed psychoeducation, family communication and problem solving, shared meaning-making, parenting, couple relationships, youth voice, and family and community resilience.
Groups were facilitated by trained facilitators, including a therapist and community volunteer, with facilitator training and supervision.
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Ingen inngripen: Waitlist Control
Clusters allocated to waitlist control did not receive MFHS during the baseline-to-endline evaluation period.
Families were invited to receive MFHS after the evaluation period.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Family Resilience
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months
|
Family resilience was measured with the Walsh Family Resilience Questionnaire.
The local version included 32 items forming belief systems, organization patterns, and communication/problem solving subscales.
Subscale scores range from 1 to 5, with higher scores indicating stronger family resilience processes.
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Baseline to immediate post-intervention endline, up to 5 months
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Change in Parenting Practices
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months
|
Parenting practices were measured with the Parenting Practices Questionnaire.
The local version included 20 items forming authoritative warmth/involvement, authoritative democratic participation, and authoritarian verbal hostility subscales.
Subscale scores range from 1 to 5, with higher scores indicating more of the named parenting behavior.
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Baseline to immediate post-intervention endline, up to 5 months
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Change in Parent Couple Functioning
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months
|
Parent couple functioning was measured with parent-only measures of dyadic adjustment, dyadic happiness, sexual relationship decision-making power, and preference for boys over girls.
Dyadic adjustment domains range from 0 to 3 and dyadic happiness ranges from 1 to 5, with higher scores indicating better couple functioning.
Sexual relationship decision-making power ranges from 1 to 3, with higher scores indicating more respondent decision-making authority.
Preference for boys over girls ranges from 1 to 4, with higher scores indicating stronger preference for boys over girls.
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Baseline to immediate post-intervention endline, up to 5 months
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Change in Youth Family-System Functioning
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months
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Youth family-system functioning was measured with youth-only family enmeshment and personal accountability scores.
Family enmeshment was measured with seven items ranging from 1 to 5, with higher scores indicating greater over-involvement or lower differentiation.
Personal accountability was measured with eight items ranging from 1 to 4, with higher scores indicating greater youth responsibility and accountability.
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Baseline to immediate post-intervention endline, up to 5 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Post-Traumatic Stress Symptoms
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months.
|
Post-traumatic stress symptoms were measured with four genocide-adapted items from the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
Items were rated from 0 to 4, with higher scores indicating greater post-traumatic stress symptoms.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in Borderline Traits
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months.
|
Borderline traits were measured with the McLean Screening Instrument for Borderline Personality Disorder.
The 10 yes/no items are summed to a total score ranging from 0 to 10, with higher scores indicating more borderline-personality features.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in Aggression
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months.
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Aggression was measured with physical and verbal aggression items from the Aggression Questionnaire.
Items were averaged to scores ranging from 1 to 5, with higher scores indicating greater aggression.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in Forgiveness and Community Relations
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months.
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Forgiveness and community relations were measured with forgiveness of others, social cohesion, perceived community threat, and intergenerational harmony scores.
Forgiveness of others used retained items derived from the Heartland Forgiveness Scale and ranges from 1 to 4, with higher scores indicating greater forgiveness.
Social cohesion ranges from 1 to 4, with higher scores indicating greater social cohesion.
Perceived community threat ranges from 1 to 4, with higher scores indicating greater perceived threat.
Intergenerational harmony ranges from 1 to 4, with higher scores indicating stronger intergenerational harmony.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in Socioemotional Skills
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months.
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Socioemotional skills were measured with locally developed emotional wellbeing, collaboration, and self-management subscales.
Subscale scores range from 1 to 4. In the scoring, higher scores indicate greater socioemotional difficulty, so lower scores indicate improvement.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in Livelihood and Household Economic Functioning
Tidsramme: Baseline to immediate post-intervention endline, up to 5 months.
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Livelihood and household economic functioning were measured with parent-only economic security, partner economic support, and food-insecurity indicators.
Economic security and partner economic support scores range from 0 to 3, with higher scores indicating greater economic security or partner support.
Short-term Food Security Consumption Coping Strategy Index scores range from 0 to 84 and long-term scores range from 0 to 12, with higher scores indicating worse food insecurity.
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Baseline to immediate post-intervention endline, up to 5 months.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alexandros Lordos, PhD, University of Cyprus
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Lordos, A., Interayamahanga, R., Kayitare, F., Dukuzumuremyi, E., Mahoro, M., Mwiza, J., & Mbanda, J. (2026). Establishing multi-stakeholder alliances to promote societal healing and resilience in post-genocide Rwanda. In S. Clarke-Habibi & C. Reimann (Eds.), The Routledge International Handbook of Trauma-Responsive Peacebuilding (pp. 411-424). Routledge. https://doi.org/10.4324/9781003536970-33
- Nikolaou, K., Lordos, A., Rutembesa, E., Ioannou, M., Dukuzumuremyi, E., Christou, G., Meade, A., Karayianni, E., Anastasiou, E., Guest, A., Sezibera, V., Panayiotou, O., Throstur, B., & Kayitare, F. (2025). Multifamily Healing Spaces: Development of a family-based intervention for recovery and resilience in Rwanda. Intervention, 23(1), 52-62. https://doi.org/10.4103/intv.intv_16_24
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MFHS-CRT-RWA-2023
- 122/RNEC/2023 (Annen identifikator: Rwanda National Research Ethics Committee approval/reference number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
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