Mental Well-beingNCT03282071
Joyful Parenting Pilot Project RCT Study
A study testing Joyful Parenting Intervention in people with Mental Well-being and Happiness, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Well-being, Happiness
- What is being tested?
- Joyful Parenting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesHong Kong
- Study dates
- 21 Sep 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- Those who cannot read Chinese
- Those who suffered from severe mental illness
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Hong Kong Family Welfare Society- North Point Integrated Family Service Centre
Hong Kong
Hong Kong Family Welfare Society- Yau Tong Integrated Family Service Centre
Hong Kong
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Mental Well-being, Happiness
- Being tested
- Joyful Parenting Intervention
- Keywords
- Mental health, Mental well-being, Community-based engagement, Positive psychology, Public health approach
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joyful Parenting InterventionBehavioural
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Joyful Parenting Intervention | Experimental | 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. Receives: Behavioral: Joyful Parenting Intervention |
| Control | No intervention | No intervention will be provided to control groups during study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
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.
Measured: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline
Secondary outcomes (8)
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.
Measured: 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
Validated Chinese version of 7-item Warwick Edinburgh Well-being Scale (7-35): higher scores indicated higher level of wellbeing.
Measured: 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
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.
Measured: 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
Respondents rated each item from 0 (not at all healthy) to 10 (very healthy), with higher scores indicating higher level of personal/family health.
Measured: 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
Respondents rated each item from 0 (not at all happy) to 10 (very happy), with higher scores indicating higher level of personal/family happiness.
Measured: 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
Respondents rated each item from 0 (not at all harmonious) to 10 (very harmonious), with higher scores indicating higher level of family harmony.
Measured: 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
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).
Measured: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Satisfaction Towards Joyful Parenting Intervention Programme
Satisfaction towards programme will be assessed by program evaluation measures: rated on a 0-10 scale, with "0" indicating "unsatisfied" and "10" indicating "satisfied".
Measured: T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start21 Sep 2017
- Primary completion30 Jun 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Well-beingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Family Welfare Society
- Responsible party
- Principal investigator, Dr Sun Yuying, The University of Hong Kong
- Investigators
- Yuying Sun, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282071
- Sponsor's protocol ID
- SPH-MHP-FWS01
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2017
- Last updated
- 25 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Wang MP, Chan CS, Lo DLO, Wan ANT, Lam TH, Ho SY. Promoting positive parenting and mental wellbeing in Hong Kong Chinese parents: A pilot cluster randomised controlled trial. PLoS One. 2022 Jul 20;17(7):e0270064. doi: 10.1371/journal.pone.0270064. eCollection 2022.
PubMed 35857769
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Mental Wellness Project for Adolescents and Adults: Joyful Parenting Pilot Project RCT Study
- ClinicalTrials.gov ID
- NCT03282071
- Acronym / sponsor ID
- SPH-MHP-FWS01
- Conditions
- Mental Well-being, Happiness
- Keywords
- Mental health, Mental well-being, Community-based engagement, Positive psychology, Public health approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Family Welfare Society
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Posted 25 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joyful Parenting Intervention | Experimental | Behavioral: Joyful Parenting InterventionSubjects 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. |
| Control | No intervention | –No intervention will be provided to control groups during study period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Parents (major subjects):
- Their family members:
- Community partners
Key exclusion criteria (2 listed)
- Those who cannot read Chinese
- Those who suffered from severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Joyful Parenting Intervention |
Primary outcome
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Time frame: 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.
8 secondary outcomes
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Satisfaction Towards Joyful Parenting Intervention Programme
Time frame: T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35857769Sun Y, Wang MP, Chan CS, Lo DLO, Wan ANT, Lam TH, Ho SY. Promoting positive parenting and mental wellbeing in Hong Kong Chinese parents: A pilot cluster randomised controlled trial. PLoS One. 2022 Jul 20;17(7):e0270064. doi: 10.1371/journal.pone.0270064. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuying Sun principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joyful Parenting Intervention in people with Mental Well-being and Happiness, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours (time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.