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Joyful Parenting Pilot Project RCT Study

3 novembre 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

144

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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).
Aucune intervention: Control
No intervention will be provided to control groups during study period.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The University of Hong Kong

Collaborateurs

Hong Kong Family Welfare Society

Les enquêteurs

  • Chercheur principal: Yuying Sun, The University of Hong Kong

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 septembre 2017

Achèvement primaire (Réel)

30 juin 2018

Achèvement de l'étude (Réel)

30 novembre 2018

Dates d'inscription aux études

Première soumission

6 septembre 2017

Première soumission répondant aux critères de contrôle qualité

11 septembre 2017

Première publication (Réel)

13 septembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 novembre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2020

Dernière vérification

1 novembre 2020

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • SPH-MHP-FWS01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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