Trial Outcomes & Findings for Effects of Mindfulness Training on the Psychological Well-being of Preschoolers (NCT NCT05058365)
NCT ID: NCT05058365
Last Updated: 2024-09-19
Results Overview
An aggregated T-score by taking the mean of the eight measures of Conners Kiddie Continuous Performance Test 2nd Edition (K-CPT 2), published by Multi-Health Systems. The eight measures are d-prime, Omissions, Commissions, Perseverations, Hit Reaction Time Standard Deviation, Variability, Hit Reaction Time Block Change, Hit Reaction Time Inter-Stimulus Interval Change. All eight measures were T-score with a population mean of 50 with a standard deviation of 10. The eight T-scores are averaged to give an overall representation of the children's attention and impulsivity. Lower score indicates better outcome.
COMPLETED
NA
18 participants
Baseline, Immediately after intervention at Week 14
2024-09-19
Participant Flow
A whole grade of K3 kindergarteners was recruited from a kindergarten in Hong Kong.
Participant milestones
| Measure |
Intervention Group
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Intervention Group
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Overall Study
Migration
|
1
|
1
|
Baseline Characteristics
Effects of Mindfulness Training on the Psychological Well-being of Preschoolers
Baseline characteristics by cohort
| Measure |
Intervention Group
n=9 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=9 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.556 years
STANDARD_DEVIATION 0.527 • n=5 Participants
|
5.000000 years
STANDARD_DEVIATION 0 • n=7 Participants
|
4.778 years
STANDARD_DEVIATION 0.428 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Immediately after intervention at Week 14An aggregated T-score by taking the mean of the eight measures of Conners Kiddie Continuous Performance Test 2nd Edition (K-CPT 2), published by Multi-Health Systems. The eight measures are d-prime, Omissions, Commissions, Perseverations, Hit Reaction Time Standard Deviation, Variability, Hit Reaction Time Block Change, Hit Reaction Time Inter-Stimulus Interval Change. All eight measures were T-score with a population mean of 50 with a standard deviation of 10. The eight T-scores are averaged to give an overall representation of the children's attention and impulsivity. Lower score indicates better outcome.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Attention and Impulsivity
Baseline
|
50.05 units on a scale
Standard Deviation 8.47
|
53.45 units on a scale
Standard Deviation 7.70
|
|
Attention and Impulsivity
After training
|
48.32 units on a scale
Standard Deviation 7.43
|
56.17 units on a scale
Standard Deviation 9.31
|
PRIMARY outcome
Timeframe: Baseline, Immediately after intervention at Week 14Scenario test depicting common social interactions faced by preschoolers. Two parallel versions are developed, each with four scenarios. For each scenario, the children are asked to identify the emotions of the character in the scenario. Answers of the same emotional valence (i.e. positive or negative) without probe score 2 points. Answer after probe score 1 point. Answers with different emotional valence or null responses score 0 points. The mean score of the four scenarios is calculated as the measure of empathy, ranging from 0 to 2. Higher scores indicate stronger empathy.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Empathy
Baseline
|
1.53 units on a scale
Standard Deviation 0.36
|
1.47 units on a scale
Standard Deviation 0.91
|
|
Empathy
After training
|
1.41 units on a scale
Standard Deviation 0.44
|
1.59 units on a scale
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: Baseline, Immediately after intervention at Week 14Scenario test depicting common social interactions faced by preschoolers. Two parallel versions are developed, each with four scenarios. For each scenario, the children are asked to identify the emotions of the character in the scenario. Answers of socially appropriate behaviors without probe score 2 points. Answer of socially appropriate behaviors after probe score 1 point. Answers with socially inappropriate behavior or null responses score 0 points. The mean score of the four scenarios is calculated as the measure of prosocial behavior, ranging from 0 to 2. Higher scores indicate more prosocial behavior.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Prosocial Behavior
Baseline
|
1.38 score on a scale
Standard Deviation 0.92
|
1.75 score on a scale
Standard Deviation 0.71
|
|
Prosocial Behavior
After training
|
1.50 score on a scale
Standard Deviation 0.76
|
1.50 score on a scale
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: Baseline, Immediately after intervention at Week 14The mean subscale score of a modified version of the Hyperactivity subscale of the parent-reported Strengths and Difficulties Questionnaire (SDQ). Originally negative Items were changed into positive wording. The subscale consisted of 3 items, rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher score indicated better attention.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Parent-reported Attention
Baseline
|
3.58 score on a scale
Standard Deviation 0.43
|
3.46 score on a scale
Standard Deviation 0.62
|
|
Parent-reported Attention
After training
|
3.54 score on a scale
Standard Deviation 0.71
|
3.50 score on a scale
Standard Deviation 0.59
|
PRIMARY outcome
Timeframe: Baseline, Immediately after intervention at Week 14The mean subscale score of a modified version of the Emotional Problem subscale of the parent-reported Strengths and Difficulties Questionnaire (SDQ). Originally negative Items were changed into positive wording. The subscale consisted of 3 items, rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher score indicated better emotion regulation.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Parent-reported Emotion Regulation
Baseline
|
3.88 score on a scale
Standard Deviation 0.40
|
3.81 score on a scale
Standard Deviation 0.55
|
|
Parent-reported Emotion Regulation
After training
|
3.88 score on a scale
Standard Deviation 0.43
|
3.88 score on a scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: Baseline, Immediately after intervention at Week 14The mean subscale score of a modified version of the Prosocial subscale of the parent-reported Strengths and Difficulties Questionnaire (SDQ). Originally negative Items were changed into positive wording. The subscale consisted of 3 items, rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher score indicated more prosocial behavior.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Parent-reported Prosocial Behavior
Baseline
|
3.67 score on a scale
Standard Deviation 0.36
|
4.08 score on a scale
Standard Deviation 0.43
|
|
Parent-reported Prosocial Behavior
After training
|
4.00 score on a scale
Standard Deviation 0.36
|
4.04 score on a scale
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: baseline, immediately after intervention at Week 14The mean subscale score of a modified version of the Conduct Problem subscale of the parent-reported Strengths and Difficulties Questionnaire (SDQ). Originally negative Items were changed into positive wording. The subscale consisted of 3 items, rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher score indicated less conduct problem.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Parent-reported Conduct
Baseline
|
3.42 score on a scale
Standard Deviation 0.50
|
3.63 score on a scale
Standard Deviation 0.63
|
|
Parent-reported Conduct
After training
|
3.58 score on a scale
Standard Deviation 0.61
|
3.54 score on a scale
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: Baseline, Immediately after intervention at Week 14The mean subscale score of a modified version of the Hyperactivity subscale of the teacher-reported Strengths and Difficulties Questionnaire (SDQ). Originally negative Items were changed into positive wording. The subscale consisted of 3 items, rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher score indicated better attention.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Teacher-reported Attention
Baseline
|
4.17 score on a scale
Standard Deviation 0.61
|
3.83 score on a scale
Standard Deviation 0.99
|
|
Teacher-reported Attention
After training
|
4.63 score on a scale
Standard Deviation 0.28
|
4.13 score on a scale
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: baseline, immediately after intervention at Week 14The mean subscale score of a modified version of the Emotional Problem subscale of the teacher-reported Strengths and Difficulties Questionnaire (SDQ). Originally negative Items were changed into positive wording. The subscale consisted of 3 items, rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher score indicated better emotion regulation.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Teacher-reported Emotion Regulation
Baseline
|
4.71 score on a scale
Standard Deviation 0.45
|
4.33 score on a scale
Standard Deviation 0.87
|
|
Teacher-reported Emotion Regulation
After training
|
4.96 score on a scale
Standard Deviation 0.12
|
4.79 score on a scale
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: baseline, immediately after intervention at Week 14The mean subscale score of a modified version of the Prosocial subscale of the teacher-reported Strengths and Difficulties Questionnaire (SDQ). Originally negative Items were changed into positive wording. The subscale consisted of 3 items, rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher score indicated more prosocial behavior.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Teacher-reported Prosocial Behavior
Baseline
|
3.79 score on a scale
Standard Deviation 0.36
|
4.08 score on a scale
Standard Deviation 0.43
|
|
Teacher-reported Prosocial Behavior
After training
|
4.00 score on a scale
Standard Deviation 0.36
|
4.04 score on a scale
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: baseline, immediately after intervention at Week 14The mean subscale score of a modified version of the Conduct Problem subscale of the teacher-reported Strengths and Difficulties Questionnaire (SDQ). Originally negative Items were changed into positive wording. The subscale consisted of 3 items, rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Higher score indicated less conduct problem.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
dots Curriculum: dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
Wait-list Control
n=8 Participants
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
|
|---|---|---|
|
Teacher-reported Conduct
Baseline
|
4.71 score on a scale
Standard Deviation 0.28
|
4.42 score on a scale
Standard Deviation 0.66
|
|
Teacher-reported Conduct
Weew
|
4.96 score on a scale
Standard Deviation 0.12
|
4.46 score on a scale
Standard Deviation 0.47
|
Adverse Events
Intervention Group
Wait-list Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place