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Joyful Parenting Pilot Project RCT Study

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ClinicalTrials.gov Identifier: NCT03282071
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Mental Well-being Happiness Behavioral: Joyful Parenting Intervention

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Community-based Mental Wellness Project for Adolescents and Adults: Joyful Parenting Pilot Project RCT Study
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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).
No Intervention: Control
No intervention will be provided to control groups during study period.


Outcome Measures

Primary Outcome Measures :
  1. Changes in participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-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


Secondary Outcome Measures :
  1. Changes in personal happiness from baseline to three-month after baseline [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Personal happiness will be assessed by Subjective Happiness Scale (SHS - 4 items)

  2. Changes in mental well-being from baseline to three-month after baseline [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Mental well-being will be assessed by validated Chinese version of 7-item Warwick Edinburgh Well-being Scale

  3. Changes in family relationship from baseline to three-month after baseline [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Self-perceived understanding, intimacy, and family communication will be assessed by a 0-10 score at 4 time points.

  4. Changes in individual and family health from baseline to three-month after baseline [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Self-perceived health, at the individual and family level will be assessed by a 0-10 score at 4 time points.

  5. Changes in family happiness from baseline to three-month after baseline [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Self-perceived family happiness will be assessed by a 0-10 score at 4 time points.

  6. Changes in family harmony from baseline to three-month after baseline [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Self-perceived family harmony will be assessed by a 0-10 score at 4 time points.

  7. Changes in life satisfaction from baseline to three-month after baseline [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Life satisfaction will be assessed by the Satisfaction With Life Scale

  8. Changes in knowledge and perception of mixed anxiety and depressive disorders [ Time Frame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Knowledge and perception of mixed anxiety and depressive disorders will be assessed by outcome-based questionnaire

  9. Satisfaction towards joyful parenting intervention programme [ Time Frame: T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline ]
    Satisfaction towards programme will be assessed by program evaluation measures and focus groups

  10. The social impact of the community-based engagement project [ Time Frame: Up to four months ]
    The social impact of the community-based engagement project will be evaluated by conducting community stakeholders' in-depth interviews

  11. The process of community-based intervention programme [ Time Frame: Up to four months ]
    Assessed by a Process Evaluation on-site observation form, and a series of checklists including Resources input record sheet, Participants' attendance form, Programme rundown, Attendance record form, and NGOs' final report. The components of process evaluation, including context, reach, dose delivered, dose received, fidelity and recruitment will be assessed.

  12. Outcomes of community engagement process [ Time Frame: Up to four months ]
    Outcomes of community engagement process will be assessed by a questionnaire survey


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282071


Contacts
Contact: Yuying Sun 3917 9144 gyysun@hku.hk
Contact: Man Ping Wang 3917 6636 mpwang@hku.hk

Locations
Hong Kong
Hong Kong Family Welfare Society- North Point Integrated Family Service Centre Recruiting
Hong Kong, Hong Kong
Contact: Daphne         
Hong Kong Family Welfare Society- Yau Tong Integrated Family Service Centre Recruiting
Hong Kong, Hong Kong
Contact: Shirley         
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Family Welfare Society
Investigators
Principal Investigator: Yuying Sun The University of Hong Kong
More Information

Responsible Party: Dr Sun Yuying, Post-doctoral Fellow, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03282071     History of Changes
Other Study ID Numbers: SPH-MHP-FWS01
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Sun Yuying, The University of Hong Kong:
Mental health
Mental well-being
Community-based engagement
Positive psychology
Public health approach