CClinicalTrials.gg
CompletedNCT03282071Updated Nov 25, 2020Results posted

Joyful Parenting Pilot Project RCT Study

An interventional study of Joyful Parenting Intervention in Mental Well-being and Happiness, sponsored by The University of Hong Kong. Completed at 2 sites in Hong Kong. Per ClinicalTrials.gov, last updated 2020-11-25.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Mental Well-being
  • Happiness

Keywords

  • Mental health
  • Mental well-being
  • Community-based engagement
  • Positive psychology
  • Public health approach
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Those who cannot read Chinese
  • Those who suffered from severe mental illness
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    No intervention will be provided to control groups during study period.

Interventions

  • BehavioralJoyful 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).

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline

Secondary outcomes

  1. Changes in Subjective Happiness From Baseline to Three-month After Baseline

    Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.

    Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

  2. 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.

    Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

  3. 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.

    Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

  4. 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.

    Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

  5. 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.

    Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

  6. 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.

    Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

  7. 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).

    Time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

  8. 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".

    Time frame: T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline

06

Results

Posted Nov 25, 2020
Limitations and caveats
Validated questionnaires were not available and many existing questionnaires were too long, we developed the outcome and impact-oriented questionnaires to assess the changes in the participants.

Participant flow

recruitment period: Aug-Oct 2017; types of location: family service centres

Participant flow — Overall Study
MilestoneJoyful Parenting InterventionControl
Started7569
Completed6560
Not completed109

Outcome measures

PrimarySharing (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.

Time frame:
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline
Reported as:
Mean · score on a scale
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
score on a scaleJoyful Parenting InterventionControl
Sharing (Praise) at baseline11.49 ± 5.1511.34 ± 4.79
Sharing (Praise) at 1-month12.23 ± 4.9111.05 ± 4.81
Sharing (Praise) at 3-month13.09 ± 4.1212.34 ± 4.22
Mind (Appreciation) at baseline7.03 ± 3.727.86 ± 3.56
Mind (Appreciation) at 1-month8.37 ± 3.668.44 ± 3.36
Mind (Appreciation) at 3-month8.86 ± 2.817.83 ± 2.91
Enjoyment at baseline7.78 ± 3.787.42 ± 3.29
Enjoyment at 1-month7.82 ± 3.227.58 ± 3.09
Enjoyment at 3-month8.92 ± 3.317.75 ± 2.77
SecondaryChanges in Subjective Happiness From Baseline to Three-month After Baseline

Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.

Time frame:
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Reported as:
Mean · score on a scale
Changes in Subjective Happiness From Baseline to Three-month After Baseline
score on a scaleJoyful Parenting InterventionControl
Subjective Happiness at baseline4.47 ± 1.194.52 ± 1.10
Subjective Happiness at 1-month5.03 ± 1.104.54 ± 1.08
Subjective Happiness at 3-month5.12 ± 0.934.64 ± 1.05
SecondaryChanges 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.

Time frame:
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Reported as:
Mean · score on a scale
Changes in Mental Well-being From Baseline to Three-month After Baseline
score on a scaleJoyful Parenting InterventionControl
Mental well-being at baseline24.82 ± 3.823.82 ± 4.62
Mental well-being at 1-month25.81 ± 3.9424.67 ± 3.74
Mental well-being at 3-month27.32 ± 3.8324.81 ± 4.55
SecondaryChanges 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.

Time frame:
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Reported as:
Mean · score on a scale
Changes in Family Relationship From Baseline to Three-month After Baseline
score on a scaleJoyful Parenting InterventionControl
Family relationship at baseline20.71 ± 6.8020.85 ± 5.05
Family relationship at 1-month22.36 ± 5.0320.73 ± 4.76
Family relationship at 3-month23.06 ± 4.6920.34 ± 5.23
SecondaryChanges 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.

Time frame:
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Reported as:
Mean · score on a scale
Changes in Personal and Family Health From Baseline to Three-month After Baseline
score on a scaleJoyful Parenting InterventionControl
Personal health at baseline6.15 ± 2.056.10 ± 2.27
Personal health at 1-month6.99 ± 2.046.18 ± 2.23
Personal health at 3-month7.29 ± 1.846.32 ± 2.15
Family health at baseline6.25 ± 2.326.25 ± 2.22
Family health at 1-month7.23 ± 1.876.48 ± 1.94
Family health at 3-month7.33 ± 1.666.50 ± 1.95
SecondaryChanges 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.

Time frame:
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Reported as:
Mean · score on a scale
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
score on a scaleJoyful Parenting InterventionControl
Personal happiness at baseline6.15 ± 2.316.15 ± 2.19
Personal happiness at 1-month6.97 ± 1.996.45 ± 2.11
Personal happiness at 3-month7.25 ± 1.796.37 ± 2.07
Family happiness at baseline6.40 ± 2.546.37 ± 2.13
Family happiness at 1-month7.38 ± 1.996.55 ± 1.92
Family happiness at 3-month7.45 ± 1.676.46 ± 1.98
SecondaryChanges 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.

Time frame:
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Reported as:
Mean · score on a scale
Changes in Family Harmony From Baseline to Three-month After Baseline
score on a scaleJoyful Parenting InterventionControl
Family harmony at baseline6.23 ± 2.596.49 ± 2.09
Family harmony at 1-month7.20 ± 2.096.80 ± 1.96
Family harmony at 3-month7.39 ± 1.896.63 ± 1.96
SecondaryChanges 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).

Time frame:
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Reported as:
Mean · score on a scale
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
score on a scaleJoyful Parenting InterventionControl
The awareness of MADD symptoms at baseline4.85 ± 2.615.30 ± 2.74
The awareness of MADD symptoms at 1-month7.33 ± 1.814.95 ± 2.90
The awareness of MADD symptoms at 3-month7.23 ± 2.075.50 ± 2.61
Intention to seek help at baseline6.28 ± 2.447.05 ± 2.49
Intention to seek help at 1-month7.47 ± 1.887.18 ± 2.21
Intention to seek help at 3-month7.72 ± 1.957.14 ± 2.25
Self-efficacy at baseline6.94 ± 2.367.07 ± 2.47
Self-efficacy at 1-month7.50 ± 2.017.24 ± 2.16
Self-efficacy at 3-month7.89 ± 1.997.04 ± 2.35
SecondarySatisfaction 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".

Time frame:
T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
Reported as:
Mean · score on a scale
Satisfaction Towards Joyful Parenting Intervention Programme
score on a scaleJoyful Parenting Intervention
Satisfaction of the 1st talk at T28.47 ± 1.44
Satisfaction of the 2nd talk at 1-month8.48 ± 1.29
Satisfaction of the family gathering at 3-month8.80 ± 1.17

Adverse events

Collected over No adverse event was observed at post-intervention (T2), 1-month (T3) or 3-month (T4).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Joyful Parenting Intervention0/75 (0%)0/75 (0%)0/75 (0%)
Control0/69 (0%)0/69 (0%)0/69 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Joyful Parenting InterventionControlTotal
Age41.8 ± 5.5143.3 ± 6.1942.5 ± 5.87
Sex: Female, Male
Sex: Female, Male(Participants)Joyful Parenting InterventionControlTotal
Female5864122
Male17522
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Joyful Parenting InterventionControlTotal
Count of participants——0
Birthplace
Birthplace(participants)Joyful Parenting InterventionControlTotal
Hong Kong282755
Guangdong Province292756
Other places181533
07

Study locations

2 sites
  • 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
    Hong Kong, Hong Kong
08

References and documents

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 documents

  • Protocol and statistical analysis plan · Jun 1, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03282071
Lead sponsor
The University of Hong Kong
Collaborators
Hong Kong Family Welfare Society
Responsible party
Dr Sun Yuying (Post-doctoral Fellow, The University of Hong Kong) — Principal investigator
First posted
Sep 13, 2017
Start date
Sep 21, 2017
Primary completion
Jun 30, 2018
Completion
Nov 30, 2018
Results posted
Nov 25, 2020
Last update
Nov 25, 2020

Study contacts

Yuying Sun
principal investigator · The University of Hong Kong

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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