- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03282071
Joyful Parenting Pilot Project RCT Study
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Hong Kong, Hong Kong
- Hong Kong Family Welfare Society- North Point Integrated Family Service Centre
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Hong Kong, Hong Kong
- Hong Kong Family Welfare Society- Yau Tong Integrated Family Service Centre
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Parents (major subjects):
- Parents aged 18-59 (including single parents)
- Chinese speaking
- Able to complete questionnaires/ focus groups
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
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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Ingen inngripen: Control
No intervention will be provided to control groups during study period.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Tidsramme: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Tidsramme: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.
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T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Changes in Mental Well-being From Baseline to Three-month After Baseline
Tidsramme: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Validated Chinese version of 7-item Warwick Edinburgh Well-being Scale (7-35): higher scores indicated higher level of wellbeing.
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T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Changes in Family Relationship From Baseline to Three-month After Baseline
Tidsramme: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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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.
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T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Changes in Personal and Family Health From Baseline to Three-month After Baseline
Tidsramme: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Respondents rated each item from 0 (not at all healthy) to 10 (very healthy), with higher scores indicating higher level of personal/family health.
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T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Tidsramme: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Respondents rated each item from 0 (not at all happy) to 10 (very happy), with higher scores indicating higher level of personal/family happiness.
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T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Changes in Family Harmony From Baseline to Three-month After Baseline
Tidsramme: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Respondents rated each item from 0 (not at all harmonious) to 10 (very harmonious), with higher scores indicating higher level of family harmony.
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T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Tidsramme: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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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).
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T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Satisfaction Towards Joyful Parenting Intervention Programme
Tidsramme: T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Satisfaction towards programme will be assessed by program evaluation measures: rated on a 0-10 scale, with "0" indicating "unsatisfied" and "10" indicating "satisfied".
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T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yuying Sun, The University of Hong Kong
Publikasjoner og nyttige lenker
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
Andre studie-ID-numre
- SPH-MHP-FWS01
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