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Multifamily Healing Spaces for Family Resilience in Rwanda (MFHS-CRT)

29. května 2026 aktualizováno: Alexandros Lordos, PhD

The Effectiveness of Multi-Family Healing Spaces on Family Resilience and Mental Health Outcomes: A Multi-Site Cluster-Randomized Waitlist-Control Trial in Rwanda

This cluster-randomized waitlist-control trial evaluated Multifamily Healing Spaces (MFHS), a culturally adapted behavioral family intervention for genocide-affected communities in Rwanda. Community members across five districts were screened through a staged triage process. Individuals with acute or severe clinical concerns were routed to clinical referral, those with individual mental-health needs were prioritized for Resilience-Oriented Therapy, and families were invited to MFHS when at least one screened family member met criteria for family communication difficulties. Twenty eligible clusters were randomly selected and then allocated to MFHS or waitlist control. The baseline cohort included 319 family members aged 12 years or older. The trial tested whether MFHS improved family resilience, parenting, couple and youth family-system outcomes, and secondary mental health, psychosocial, community, and livelihood outcomes from baseline to immediate post-intervention endline.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

319

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Rwanda
    • Eastern Province
      • Ngoma, Eastern Province, Rwanda
        • Community and Health-Centre Settings, Ngoma District
      • Nyagatare, Eastern Province, Rwanda
        • Community and Health-Centre Settings, Nyagatare District
    • Northern Province
      • Ruhengeri, Northern Province, Rwanda
        • Community and Health-Centre Settings, Musanze District
    • Southern Province
      • Nyamagabe, Southern Province, Rwanda
        • Community and Health-Centre Settings, Nyamagabe District
    • Western Province
      • Nyabihu, Western Province, Rwanda
        • Community and Health-Centre Settings, Nyabihu District

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: Multifamily Healing Spaces
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.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Family Resilience
Časové okno: 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.
Baseline to immediate post-intervention endline, up to 5 months
Change in Parenting Practices
Časové okno: 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.
Baseline to immediate post-intervention endline, up to 5 months
Change in Parent Couple Functioning
Časové okno: 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.
Baseline to immediate post-intervention endline, up to 5 months
Change in Youth Family-System Functioning
Časové okno: Baseline to immediate post-intervention endline, up to 5 months
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.
Baseline to immediate post-intervention endline, up to 5 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Post-Traumatic Stress Symptoms
Časové okno: 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.
Baseline to immediate post-intervention endline, up to 5 months.
Change in Borderline Traits
Časové okno: 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.
Baseline to immediate post-intervention endline, up to 5 months.
Change in Aggression
Časové okno: Baseline to immediate post-intervention endline, up to 5 months.
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.
Baseline to immediate post-intervention endline, up to 5 months.
Change in Forgiveness and Community Relations
Časové okno: Baseline to immediate post-intervention endline, up to 5 months.
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.
Baseline to immediate post-intervention endline, up to 5 months.
Change in Socioemotional Skills
Časové okno: Baseline to immediate post-intervention endline, up to 5 months.
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.
Baseline to immediate post-intervention endline, up to 5 months.
Change in Livelihood and Household Economic Functioning
Časové okno: Baseline to immediate post-intervention endline, up to 5 months.
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.
Baseline to immediate post-intervention endline, up to 5 months.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Alexandros Lordos, PhD

Spolupracovníci

University of Rwanda
Centre for Sustainable Peace and Democratic Development
Interpeace

Vyšetřovatelé

  • Vrchní vyšetřovatel: Alexandros Lordos, PhD, University of Cyprus

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

  • 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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

28. dubna 2023

Primární dokončení (Aktuální)

15. září 2023

Dokončení studie (Aktuální)

15. září 2023

Termíny zápisu do studia

První předloženo

20. května 2026

První předloženo, které splnilo kritéria kontroly kvality

29. května 2026

První zveřejněno (Aktuální)

2. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MFHS-CRT-RWA-2023
  • 122/RNEC/2023 (Jiný identifikátor: Rwanda National Research Ethics Committee approval/reference number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified participant-level data underlying the manuscript analyses may be shared with qualified researchers on reasonable request to the first author, subject to ethics, data-protection, and partner-organization approvals.

Časový rámec sdílení IPD

Available after publication, with no predetermined end date.

Kritéria přístupu pro sdílení IPD

Researchers must submit a methodologically sound proposal to the first author. Access will be subject to approval by the study team and any applicable ethics, data-protection, and partner-organization requirements. Shared data will be de-identified.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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