- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07494071
Att förbättra familjekommunikation hos äldre vuxna: En pilotstudie med randomiserad kontrollerad design (ReFrame-P)
2 september 2026 uppdaterad av: YU Yee Man Branda, The University of Hong Kong
Pilotutvärdering av ReFrame-R: En kommunikationsträning för att omformulera äldre vuxnas familjeroller och främja aktivt åldrande
Denna studie utvärderar effektiviteten av "ReFrame-R", ett kommunikationsträningsprogram utformat för att hjälpa äldre vuxna i Hong Kong att hantera utmaningar mellan generationer.
Genom att fokusera på att förbättra kommunikationskompetens och klargöra rollgränser inom förälder-barn-relationer, söker forskningen avgöra om denna specialiserade intervention kan förbättra den mentala välfärden för både äldre och yngre generationer.
Studien frågar om deltagande i "ReFrame-R"-läroplanen leder till mätbara förbättringar i hur familjer interagerar, med hypotesen att äldre vuxna i träningsgruppen kommer att uppvisa signifikant bättre kommunikationskvalitet och en starkare känsla av mening jämfört med dem i en kontrollgrupp.
Denna studie syftar också till att utvärdera programmets övergripande genomförbarhet och acceptans.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
42
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Hong Kong, Hong Kong, 000000
- The University of Hong Kong
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- Kantonesisktalande äldre vuxna
- har regelbunden kontakt med vuxna barn
- kan förstå traditionell kinesiska
Exklusionskriterier:
- känd mental hälsodiagnos
- lindriga eller högre depressiva symptom (poäng ≥5 på Patient Health Questionnaire [PHQ-9; Kroenke et al., 2001; Manea et al., 2015])
- kommunikationssvårigheter
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: ReFrame-R utbildning
ReFrame-R består av fyra veckovis återkommande 90-minuters gruppsessioner (totalt 6 timmar), kompletterade med korta veckovisa individuella konsultationer för att felsöka hinder och stärka hemövningar.
Anpassat från en befintlig MI-protokoll för lekmän (Kline et al., 2022), är programmet grundat i Familjesystemteori för att hantera över-/underfunktionerande dynamik i äldre förälder-vuxenbarnrelationer, samtidigt som det betonar empatisk lyssnande och autonomistödjande kommunikation.
En MI-färdighetsbroschyr kommer att delas ut för att stödja och dokumentera hemövningar.
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ReFrame-R-programmet är anpassat från ett etablerat Motivational Interviewing (MI)-protokoll för lekmän (Kline et al., 2022). Grundat i Familjesystemteori, adresserar läroplanen specifikt överfunktionella och underfunktionella dynamiker som ofta återfinns i äldre förälder-vuxen barn-dyader och den kulturella specifika kontexten i Hong Kong. Till skillnad från generella kommunikationsworkshops, betonar detta program rollgränser inom förälder-vuxen barn-relationen.
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Inget ingripande: Kontrollgrupp
Deltagarna i kontrollgruppen kommer inte att få aktiv träning under studieperioden.
De kommer att få samma MI-färdighetsbok för referens och självstyrd träning.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Perceived communication competence
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Self-efficacy
Tidsram: 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-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
Tidsram: 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 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Week 4 (end of training)
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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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Romppel M, Herrmann-Lingen C, Wachter R, Edelmann F, Dungen HD, Pieske B, Grande G. A short form of the General Self-Efficacy Scale (GSE-6): Development, psychometric properties and validity in an intercultural non-clinical sample and a sample of patients at risk for heart failure. Psychosoc Med. 2013;10:Doc01. doi: 10.3205/psm000091. Epub 2013 Feb 20.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 mars 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
16 mars 2026
Först inskickad som uppfyllde QC-kriterierna
19 mars 2026
Första postat (Faktisk)
27 mars 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- EA260121
- 2501262488 (Annat bidrag/finansieringsnummer: The University of Hong Kong)
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