Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Joyful Parenting Pilot Project RCT Study

3 november 2020 bijgewerkt door: Dr Sun Yuying, The University of Hong Kong

Community-based Mental Wellness Project for Adolescents and Adults: Joyful Parenting Pilot Project RCT Study

Aims: To enhance mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community.

Targets: Parents aged 12-59 and their family members in Hong Kong.

Methods: Joyful Parenting Pilot Project will adopt the public health and family-focused approach, under the brand name of "Joyful@HK Campaign". Evidence-based and Evidence Generating approach with vigorous study design, both qualitative (e.g. focus groups) and quantitative (e.g. randomised controlled trial), will be used to evaluate the overall programme effectiveness including follow-up of at least one month ("best science"). To ensure the practicability and sustainability of the CBEP, we will engage community partners with strong track records of "best practice" to design, plan, and implement the intervention. This project will use innovative and integrated positive psychology and public health theories and methods to plan brief, simple, and cost-effective intervention.

Significance: By using "best science" in the design and evaluation of intervention programme, and the "best practice" of the partners' skills, experience and strong connection with service targets in the community, the intervention, if proven to be effective, for promoting sharing, mind and enjoyment and enhancing mental wellbeing can be further developed and widely disseminated to and adopted by the practitioners in the health and social service sectors for replication and improvement to benefit the whole population.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Joyful Parenting Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at enhancing mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community. The Project is funded by Health Care and Promotion Fund of Food and Health Bureau.

Joyful Parenting Pilot Project is organized by the Hong Kong Family Welfare Society and led by the School of Public Health, The University of Hong Kong (HKU). The project will organize two-session interactive talks for parents to promote praise and appreciation, positive thinking, enjoyable parenting and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder) and mental well-being; and one family gathering activity to promote and practice quality family communication. One wisdom sharing session will be organized for social workers and service practitioners to promote best practice of community mental wellness project.

The major subjects of the Joyful Parenting Pilot Project RCT Study are 120 parents and at least 240 family members. 4 family service units of Hong Kong Family Welfare Society will either be assigned into intervention groups or wait-list control groups. Cluster Randomized Controlled Trial will be used to evaluate the effectiveness of the intervention programme.

In the study, parents and their family members will be invited to complete questionnaires to measure the behavioral indicators of sharing, mind and enjoyment, and mental well-being and/or invited to attend the focus group to understand the participants' experience during the programme while community partners will be invited to individual in-depth interviews. HKU team will conduct evaluation during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention will also be evaluated.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

144

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Hongkong
      • Hong Kong, Hongkong
        • Hong Kong Family Welfare Society- North Point Integrated Family Service Centre
      • Hong Kong, Hongkong
        • Hong Kong Family Welfare Society- Yau Tong Integrated Family Service Centre

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Parents (major subjects):

    • Parents aged 18-59 (including single parents)
    • Chinese speaking
    • Able to complete questionnaires/ focus groups

  2. Their family members:

    • Family members of those parents who have already participated in the Joyful Parenting Pilot Project (Their family members could be children/ adolescents)
    • Chinese speaking
    • Able to complete questionnaires/ focus groups

  3. Community partners

    • Staff of Integrated Family Service Units, under Hong Kong Family Welfare Society in partnership with HKU research team, who organize, plan or implement the project
    • Adults aged 18 or above
    • Chinese speaking
    • Able to complete questionnaires/ individual in-depth interviews

Exclusion Criteria:

  • Those who cannot read Chinese
  • Those who suffered from severe mental illness

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Joyful Parenting Intervention
Subjects will participate in two-session interactive talks on joyful parenting (a core session intervention and booster intervention) and one family gathering activity; questionnaire evaluation will be conducted at baseline, post-session,1 month and 3 month after core session.
Gedragsmatig: Joyful Parenting Intervention
  • Two-session interactive talks for parents to promote praise & appreciation, positive thinking, enjoyable parenting (mind) and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder) and mental well-being.
  • One family gathering activity (e.g. outdoor / visit / family indoor gathering) to promote and practise quality family communication (enjoyment and sharing).
Geen tussenkomst: Control
No intervention will be provided to control groups during study period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Tijdsspanne: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline

Outcome-based questionnaire will be used to evaluate participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours from baseline to three-month after baseline.

Praise: 3-item (range: 0-21). Higher scores mean a better outcome. Appreciation: 2-item (range: 0-14). Higher scores mean a better outcome. Enjoyment: 2-item (range: 0-14). Higher scores mean a better outcome.
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Tijdsspanne: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Changes in Mental Well-being From Baseline to Three-month After Baseline
Tijdsspanne: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Validated Chinese version of 7-item Warwick Edinburgh Well-being Scale (7-35): higher scores indicated higher level of wellbeing.
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Changes in Family Relationship From Baseline to Three-month After Baseline
Tijdsspanne: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Respondents rated each item from 0 (no understanding / intimacy / communication at all with family members) to 10 (full understanding / intimacy / communication with family members), resulting in a total score of 0-30, with higher scores indicating better family relationship.
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Changes in Personal and Family Health From Baseline to Three-month After Baseline
Tijdsspanne: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Respondents rated each item from 0 (not at all healthy) to 10 (very healthy), with higher scores indicating higher level of personal/family health.
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Tijdsspanne: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Respondents rated each item from 0 (not at all happy) to 10 (very happy), with higher scores indicating higher level of personal/family happiness.
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Changes in Family Harmony From Baseline to Three-month After Baseline
Tijdsspanne: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Respondents rated each item from 0 (not at all harmonious) to 10 (very harmonious), with higher scores indicating higher level of family harmony.
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Tijdsspanne: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
The knowledge and understandings of MADD was self-developed to assess the level of awareness of the MADD symptoms ("I know the symptoms of MADD", range 0 to 10), intention to seek help ("I will talk to families or friends when I have emotional disturbance", range 0-10), self-efficacy of help seeking ("I know how to seek help when I have emotional disturbance", range 0-10), and understanding of the MADD definition ("MADD refers to the condition when both anxiety and depression are diagnosed", yes/no/uncertain).
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Satisfaction Towards Joyful Parenting Intervention Programme
Tijdsspanne: T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Satisfaction towards programme will be assessed by program evaluation measures: rated on a 0-10 scale, with "0" indicating "unsatisfied" and "10" indicating "satisfied".
T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The University of Hong Kong

Medewerkers

Hong Kong Family Welfare Society

Onderzoekers

  • Hoofdonderzoeker: Yuying Sun, The University of Hong Kong

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 september 2017

Primaire voltooiing (Werkelijk)

30 juni 2018

Studie voltooiing (Werkelijk)

30 november 2018

Studieregistratiedata

Eerst ingediend

6 september 2017

Eerst ingediend dat voldeed aan de QC-criteria

11 september 2017

Eerst geplaatst (Werkelijk)

13 september 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 november 2020

Laatste update ingediend die voldeed aan QC-criteria

3 november 2020

Laatst geverifieerd

1 november 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • SPH-MHP-FWS01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Mentale gezondheid

Klinische onderzoeken op Joyful Parenting Intervention

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Egypt

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren