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The present study is a randomized controlled trial to evaluate the effectiveness of a mindfulness course on the psychological well-being of preschoolers (i.e., attention and impulsivity, prosocial behavior, empathy, emotion regulation and conduct). Participants will be randomized to either intervention (dots Curriculum) or wait-list control condition. Participants will complete a computerized task and they will be interviewed to complete a scenario test before (baseline) and after the intervention. The parents and class teacher will also be invited to complete a survey at baseline and after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Wait-list control | No Intervention | Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dots Curriculum | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Attention and Impulsivity | 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. | Baseline, Immediately after intervention at Week 14 |
| Empathy | Scenario 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. | Baseline, Immediately after intervention at Week 14 |
| Prosocial Behavior | Scenario 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. | Baseline, Immediately after intervention at Week 14 |
| Parent-reported Attention |
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| Name | Affiliation | Role |
|---|---|---|
| Shui-fong Lam | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jockey Club "Peace and Awareness" Mindfulness Culture in Schools Initiative, Faculty of Social Sciences, The University of Hong Kong | Hong Kong | Hong Kong |
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A whole grade of K3 kindergarteners was recruited from a kindergarten in Hong Kong.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attention and Impulsivity | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Immediately after intervention at Week 14 |
|
99 days (the duration of the training period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Lam Shui-fong | The University of Hong Kong | 85239172388 | lamsf@hku.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2021 | Dec 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2021 | Nov 3, 2022 | ICF_001.pdf |
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The 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.
| Baseline, Immediately after intervention at Week 14 |
| Parent-reported Emotion Regulation | The 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. | Baseline, Immediately after intervention at Week 14 |
| Parent-reported Prosocial Behavior | The 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. | Baseline, Immediately after intervention at Week 14 |
| Parent-reported Conduct | The 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. | baseline, immediately after intervention at Week 14 |
| Teacher-reported Attention | The 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. | Baseline, Immediately after intervention at Week 14 |
| Teacher-reported Emotion Regulation | The 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. | baseline, immediately after intervention at Week 14 |
| Teacher-reported Prosocial Behavior | The 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. | baseline, immediately after intervention at Week 14 |
| Teacher-reported Conduct | The 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. | baseline, immediately after intervention at Week 14 |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| Primary | Empathy | Scenario 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Immediately after intervention at Week 14 |
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| Primary | Prosocial Behavior | Scenario 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Immediately after intervention at Week 14 |
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| Primary | Parent-reported Attention | The 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Immediately after intervention at Week 14 |
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| Primary | Parent-reported Emotion Regulation | The 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Immediately after intervention at Week 14 |
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| Primary | Parent-reported Prosocial Behavior | The 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Immediately after intervention at Week 14 |
|
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| Primary | Parent-reported Conduct | The 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately after intervention at Week 14 |
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| Primary | Teacher-reported Attention | The 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Immediately after intervention at Week 14 |
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| Primary | Teacher-reported Emotion Regulation | The 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately after intervention at Week 14 |
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| Primary | Teacher-reported Prosocial Behavior | The 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately after intervention at Week 14 |
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| Primary | Teacher-reported Conduct | The 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately after intervention at Week 14 |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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