- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07494071
Forbedring av familiekommunikasjon hos eldre: En pilotstudie med randomisert kontrollert design (ReFrame-P)
2. september 2026 oppdatert av: YU Yee Man Branda, The University of Hong Kong
Pilotevaluering av ReFrame-R: En kommunikasjonstrening for å omramme eldre voksnes familiære roller og fremme aktiv aldring
Denne studien evaluerer effektiviteten av "ReFrame-R", et kommunikasjonstreningprogram designet for å hjelpe eldre voksne i Hong Kong å håndtere intergenerasjonsutfordringer.
Ved å fokusere på å forbedre kommunikasjonskompetanse og klargjøre rollebegrensninger innen forelder-barn-relasjoner, søker forskningen å avgjøre om denne spesialiserte intervensjonen kan forbedre den mentale velværen til både eldre og yngre generasjoner.
Studien spør om deltakelse i "ReFrame-R"-pensumet fører til målbare forbedringer i hvordan familier samhandler, med hypotesen om at eldre voksne i treningsgruppen vil vise betydelig bedre kommunikasjonskvalitet og en sterkere følelse av mening sammenlignet med de i en kontrollgruppe.
Denne studien har også som mål å evaluere programmets generelle gjennomførbarhet og akseptabilitet.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
42
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Hong Kong, Hong Kong, 000000
- The University of Hong Kong
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Kantonesisk-talende eldre voksne
- har regelmessig kontakt med voksne barn
- kan forstå tradisjonell kinesisk
Eksklusjonskriterier:
- kjent psykisk helsediagnose
- milde eller alvorligere depressive symptomer (scoret ≥5 på Patient Health Questionnaire [PHQ-9; Kroenke et al., 2001; Manea et al., 2015])
- kommunikasjonsvansker
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: ReFrame-R-opplæring
ReFrame-R består av fire ukentlige 90-minutters gruppesessioner (totalt 6 timer), supplert med korte ukentlige individuelle konsultasjoner for å feilsøke barrierer og forsterke hjemmetrening.
Tilpasset fra en eksisterende MI-protokoll for lekfolk (Kline et al., 2022), er programmet forankret i familiens systemteori for å adressere over-/underfunksjonsdynamikk i eldre forelder-voksne barn-relasjoner, samtidig som det også legger vekt på empatisk lytte og autonomistøttende kommunikasjon.
En MI-ferdighetsbok vil bli distribuert for å støtte og registrere hjemmetrening.
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ReFrame-R-programmet er tilpasset fra et etablert Motivational Interviewing (MI)-protokoll for lekfolk (Kline et al., 2022).
Forankret i Family Systems Theory, adresserer pensumet spesifikt overfunksjonerende og underfunksjonerende dynamikker som ofte finnes i eldre forelder-voksen barn-dyader og den kulturelt spesifikke konteksten i Hong Kong.
I motsetning til generelle kommunikasjonsverksteder, legger dette programmet vekt på rolleavgrensninger innenfor forelder-voksen barn-relasjonen.
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Ingen inngripen: Kontrollgruppe
Deltakerne i kontrollgruppen vil ikke motta aktiv trening i studieperioden.
De vil få tilsendt samme MI-ferdighetshefte for referanse og egenstyrt praksis.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Perceived communication competence
Tidsramme: Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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Participants' self-perceived communication competence is assessed using an 11-item scale adapted from the Family Communication Scale (FCS).
The scale consists of 10 items adapted from the original FCS to measure perceived ability to engage in positive communication with adult children, plus an additional item regarding overall communicagtion competence.
Each item is rated on a 5-point scale (1-5), with a total score ranging from 11 to 55. Higher scores indicate a higher level of perceived communication competence.
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Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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Meaning in life
Tidsramme: Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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The 10-item Meaning in Life Questionnaire (MLQ; Steger et al., 2006) is used.
It consists of two subscales: presence of meaning (5 items) and search of meaning (5 items).
Each subscale is rated on a 7-point scale, with summed scores are calculated (ranged 5-35 for each).
Higher scores indicate stronger sense of purpose and motivation to find meaning, respectively.
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Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Self-efficacy
Tidsramme: Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
|
Participants' self-efficacy will be assessed using the 6-item General Self-Efficacy Scale (GSE-6; Romppel et al., 2013).
It is typically rated on a 4-point scale from 1 to 4. Total scores range from 6 to 24, with higher scores reflecting greater perceived self-efficacy.
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Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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Well-being
Tidsramme: Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
|
The 5-item WHO Well-Being Index will be adopted for measuring participants' subjective well-being (Bech, 1998; Kong et al., 2016), rated on a 7-point scale.
The WHO-5 score ranges from 0 to 25, zero representing worst possible mental well-being and 25 representing best possible mental well-being.
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Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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Role boundaries
Tidsramme: Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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We used a 5-item scale adapted from the Control subscale of the Parent-Adult Child Relationship Questionnaire's Relationship with Father component (PACQF; Peisah et al., 1999).
While the original scale assess children's perceptions of parental conrtol, this adapted version is a self-report measure for parent to assess their attempt to maintain power, influence, or dominance over their adult children.
Each item is rated on a 5-point scale, with a total score ranging 5-25.
Higher scores indicater higher levels of parent control, reflecting weaker awareness of role boundaries in parent-adult children relationship.
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Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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Family functioning
Tidsramme: Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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The 5-item Family Adaption, Partnership, Growth, Affection, Resolve questionnaire (Family APGAR; Chan et al., 1988; Smilkstein, 1978) is used.
This scale assesses participants' satisfaction with five aspects of family function.
Each item is rated on a 3-point scale (0-2), with a total score ranged from 0 to 10. Higher scores indicate better family functioning.
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Both groups: Baseline, Week 4 (end of training), Week 6 (2 weeks follow-up); Intervention group only: 4 months post-training
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Training appropriateness
Tidsramme: Week 6 (2 week follow-up)
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We used the 4-item Intervention Appropriateness Measure (IAM) from Weiner et al (2017) to access training appropriateness.
All items are rated on a 5-point scale (1-5), with an average score being calculated.
Higher scores indicate greater perceived appropriateness of training.
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Week 6 (2 week follow-up)
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Training acceptability
Tidsramme: Week 6 (2 week follow-up)
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The 4-item Acceptability of Intervention Measure (AIM) from Weiner et al (2017) is adopted to access training appropriateness.
All items are rated on a 5-point scale (1-5), with an average score being calculated.
Higher scores indicate greater perceived acceptability of training.
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Week 6 (2 week follow-up)
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Training feasibility
Tidsramme: Week 4 (end of training)
|
This study used the 4-item Intervention Appropriateness Measure (IAM) from Weiner et al (2017) to access training feasibility.
All items are rated on a 5-point scale (1-5), with an average score being calculated.
Higher scores indicate greater perceived feasibility of training.
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Week 4 (end of training)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. mars 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. juni 2027
Datoer for studieregistrering
Først innsendt
16. mars 2026
Først innsendt som oppfylte QC-kriteriene
19. mars 2026
Først lagt ut (Faktiske)
27. mars 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- EA260121
- 2501262488 (Annet stipend/finansieringsnummer: The University of Hong Kong)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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