Trial Outcomes & Findings for Joyful Parenting Pilot Project RCT Study (NCT NCT03282071)

NCT ID: NCT03282071

Last Updated: 2020-11-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

144 participants

Primary outcome timeframe

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

Results posted on

2020-11-25

Participant Flow

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

8 parents excluded (not meeting inclusion criteria 18-59 years)

Unit of analysis: family service centres

Participant milestones

Participant milestones
Measure
Joyful Parenting Intervention
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
No intervention were provided to control groups during assessment period.
Overall Study
STARTED
75 2
69 2
Overall Study
COMPLETED
65 2
60 2
Overall Study
NOT COMPLETED
10 0
9 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention were provided to control groups during study period.
Total
n=144 Participants
Total of all reporting groups
Age, Continuous
Age
41.8 years
STANDARD_DEVIATION 5.51 • n=75 Participants
43.3 years
STANDARD_DEVIATION 6.19 • n=69 Participants
42.5 years
STANDARD_DEVIATION 5.87 • n=144 Participants
Sex: Female, Male
Female
58 Participants
n=75 Participants
64 Participants
n=69 Participants
122 Participants
n=144 Participants
Sex: Female, Male
Male
17 Participants
n=75 Participants
5 Participants
n=69 Participants
22 Participants
n=144 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Birthplace
Hong Kong
28 participants
n=75 Participants
27 participants
n=69 Participants
55 participants
n=144 Participants
Birthplace
Guangdong Province
29 participants
n=75 Participants
27 participants
n=69 Participants
56 participants
n=144 Participants
Birthplace
Other places
18 participants
n=75 Participants
15 participants
n=69 Participants
33 participants
n=144 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention will be provided to control groups during study period.
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Sharing (Praise) at baseline
11.49 score on a scale
Standard Deviation 5.15
11.34 score on a scale
Standard Deviation 4.79
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Sharing (Praise) at 1-month
12.23 score on a scale
Standard Deviation 4.91
11.05 score on a scale
Standard Deviation 4.81
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Sharing (Praise) at 3-month
13.09 score on a scale
Standard Deviation 4.12
12.34 score on a scale
Standard Deviation 4.22
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Mind (Appreciation) at baseline
7.03 score on a scale
Standard Deviation 3.72
7.86 score on a scale
Standard Deviation 3.56
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Mind (Appreciation) at 1-month
8.37 score on a scale
Standard Deviation 3.66
8.44 score on a scale
Standard Deviation 3.36
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Mind (Appreciation) at 3-month
8.86 score on a scale
Standard Deviation 2.81
7.83 score on a scale
Standard Deviation 2.91
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Enjoyment at baseline
7.78 score on a scale
Standard Deviation 3.78
7.42 score on a scale
Standard Deviation 3.29
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Enjoyment at 1-month
7.82 score on a scale
Standard Deviation 3.22
7.58 score on a scale
Standard Deviation 3.09
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Enjoyment at 3-month
8.92 score on a scale
Standard Deviation 3.31
7.75 score on a scale
Standard Deviation 2.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention will be provided to control groups during study period.
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Subjective Happiness at baseline
4.47 score on a scale
Standard Deviation 1.19
4.52 score on a scale
Standard Deviation 1.10
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Subjective Happiness at 1-month
5.03 score on a scale
Standard Deviation 1.10
4.54 score on a scale
Standard Deviation 1.08
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Subjective Happiness at 3-month
5.12 score on a scale
Standard Deviation 0.93
4.64 score on a scale
Standard Deviation 1.05

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention will be provided to control groups during study period.
Changes in Mental Well-being From Baseline to Three-month After Baseline
Mental well-being at baseline
24.82 score on a scale
Standard Deviation 3.8
23.82 score on a scale
Standard Deviation 4.62
Changes in Mental Well-being From Baseline to Three-month After Baseline
Mental well-being at 1-month
25.81 score on a scale
Standard Deviation 3.94
24.67 score on a scale
Standard Deviation 3.74
Changes in Mental Well-being From Baseline to Three-month After Baseline
Mental well-being at 3-month
27.32 score on a scale
Standard Deviation 3.83
24.81 score on a scale
Standard Deviation 4.55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention will be provided to control groups during study period.
Changes in Family Relationship From Baseline to Three-month After Baseline
Family relationship at baseline
20.71 score on a scale
Standard Deviation 6.80
20.85 score on a scale
Standard Deviation 5.05
Changes in Family Relationship From Baseline to Three-month After Baseline
Family relationship at 1-month
22.36 score on a scale
Standard Deviation 5.03
20.73 score on a scale
Standard Deviation 4.76
Changes in Family Relationship From Baseline to Three-month After Baseline
Family relationship at 3-month
23.06 score on a scale
Standard Deviation 4.69
20.34 score on a scale
Standard Deviation 5.23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention will be provided to control groups during study period.
Changes in Personal and Family Health From Baseline to Three-month After Baseline
Personal health at baseline
6.15 score on a scale
Standard Deviation 2.05
6.10 score on a scale
Standard Deviation 2.27
Changes in Personal and Family Health From Baseline to Three-month After Baseline
Personal health at 1-month
6.99 score on a scale
Standard Deviation 2.04
6.18 score on a scale
Standard Deviation 2.23
Changes in Personal and Family Health From Baseline to Three-month After Baseline
Personal health at 3-month
7.29 score on a scale
Standard Deviation 1.84
6.32 score on a scale
Standard Deviation 2.15
Changes in Personal and Family Health From Baseline to Three-month After Baseline
Family health at baseline
6.25 score on a scale
Standard Deviation 2.32
6.25 score on a scale
Standard Deviation 2.22
Changes in Personal and Family Health From Baseline to Three-month After Baseline
Family health at 1-month
7.23 score on a scale
Standard Deviation 1.87
6.48 score on a scale
Standard Deviation 1.94
Changes in Personal and Family Health From Baseline to Three-month After Baseline
Family health at 3-month
7.33 score on a scale
Standard Deviation 1.66
6.50 score on a scale
Standard Deviation 1.95

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention will be provided to control groups during study period.
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Personal happiness at baseline
6.15 score on a scale
Standard Deviation 2.31
6.15 score on a scale
Standard Deviation 2.19
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Personal happiness at 1-month
6.97 score on a scale
Standard Deviation 1.99
6.45 score on a scale
Standard Deviation 2.11
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Personal happiness at 3-month
7.25 score on a scale
Standard Deviation 1.79
6.37 score on a scale
Standard Deviation 2.07
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Family happiness at baseline
6.40 score on a scale
Standard Deviation 2.54
6.37 score on a scale
Standard Deviation 2.13
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Family happiness at 1-month
7.38 score on a scale
Standard Deviation 1.99
6.55 score on a scale
Standard Deviation 1.92
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Family happiness at 3-month
7.45 score on a scale
Standard Deviation 1.67
6.46 score on a scale
Standard Deviation 1.98

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention will be provided to control groups during study period.
Changes in Family Harmony From Baseline to Three-month After Baseline
Family harmony at baseline
6.23 score on a scale
Standard Deviation 2.59
6.49 score on a scale
Standard Deviation 2.09
Changes in Family Harmony From Baseline to Three-month After Baseline
Family harmony at 1-month
7.20 score on a scale
Standard Deviation 2.09
6.80 score on a scale
Standard Deviation 1.96
Changes in Family Harmony From Baseline to Three-month After Baseline
Family harmony at 3-month
7.39 score on a scale
Standard Deviation 1.89
6.63 score on a scale
Standard Deviation 1.96

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
n=69 Participants
No intervention will be provided to control groups during study period.
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Intention to seek help at 1-month
7.47 score on a scale
Standard Deviation 1.88
7.18 score on a scale
Standard Deviation 2.21
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Intention to seek help at 3-month
7.72 score on a scale
Standard Deviation 1.95
7.14 score on a scale
Standard Deviation 2.25
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
The awareness of MADD symptoms at baseline
4.85 score on a scale
Standard Deviation 2.61
5.30 score on a scale
Standard Deviation 2.74
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
The awareness of MADD symptoms at 1-month
7.33 score on a scale
Standard Deviation 1.81
4.95 score on a scale
Standard Deviation 2.90
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
The awareness of MADD symptoms at 3-month
7.23 score on a scale
Standard Deviation 2.07
5.50 score on a scale
Standard Deviation 2.61
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Intention to seek help at baseline
6.28 score on a scale
Standard Deviation 2.44
7.05 score on a scale
Standard Deviation 2.49
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Self-efficacy at baseline
6.94 score on a scale
Standard Deviation 2.36
7.07 score on a scale
Standard Deviation 2.47
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Self-efficacy at 1-month
7.50 score on a scale
Standard Deviation 2.01
7.24 score on a scale
Standard Deviation 2.16
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Self-efficacy at 3-month
7.89 score on a scale
Standard Deviation 1.99
7.04 score on a scale
Standard Deviation 2.35

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure
Joyful Parenting Intervention
n=75 Participants
Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD). After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.
Control
No intervention will be provided to control groups during study period.
Satisfaction Towards Joyful Parenting Intervention Programme
Satisfaction of the 2nd talk at 1-month
8.48 score on a scale
Standard Deviation 1.29
Satisfaction Towards Joyful Parenting Intervention Programme
Satisfaction of the family gathering at 3-month
8.80 score on a scale
Standard Deviation 1.17
Satisfaction Towards Joyful Parenting Intervention Programme
Satisfaction of the 1st talk at T2
8.47 score on a scale
Standard Deviation 1.44

Adverse Events

Joyful Parenting Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yuying Sun

The University of Hong Kong

Phone: (852)39179144

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place