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Effects of Mindfulness Training on the Psychological Well-being of Preschoolers

Effects of Mindfulness Training on the Psychological Well-being of Preschoolers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05058365
Enrollment
18
Registered
2021-09-27
Start date
2021-09-01
Completion date
2022-06-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mindfulness-based Intervention for Preschoolers

Keywords

mindfulness, psychological well-being of preschoolers

Brief summary

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.

Interventions

BEHAVIORALdots 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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 3-6 years * Studying in pre-school settings

Design outcomes

Primary

MeasureTime frameDescription
Parent-reported AttentionBaseline, 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.
Attention and ImpulsivityBaseline, 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.
EmpathyBaseline, 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.
Prosocial BehaviorBaseline, 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.
Parent-reported Emotion RegulationBaseline, 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.
Parent-reported Prosocial BehaviorBaseline, 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.
Parent-reported Conductbaseline, 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.
Teacher-reported AttentionBaseline, 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.
Teacher-reported Emotion Regulationbaseline, 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.
Teacher-reported Prosocial Behaviorbaseline, 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.
Teacher-reported Conductbaseline, 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.

Countries

Hong Kong

Participant flow

Recruitment details

A whole grade of K3 kindergarteners was recruited from a kindergarten in Hong Kong.

Participants by arm

ArmCount
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.
9
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.
9
Total18

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyMigration11

Baseline characteristics

CharacteristicIntervention GroupTotalWait-list Control
Age, Continuous4.556 years
STANDARD_DEVIATION 0.527
4.778 years
STANDARD_DEVIATION 0.428
5.000000 years
STANDARD_DEVIATION 0
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
9 Participants18 Participants9 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Hong Kong
9 participants18 participants9 participants
Sex: Female, Male
Female
5 Participants9 Participants4 Participants
Sex: Female, Male
Male
4 Participants9 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 9
other
Total, other adverse events
0 / 90 / 9
serious
Total, serious adverse events
0 / 90 / 9

Outcome results

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.

Time frame: Baseline, Immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupAttention and ImpulsivityBaseline50.05 units on a scaleStandard Deviation 8.47
Intervention GroupAttention and ImpulsivityAfter training48.32 units on a scaleStandard Deviation 7.43
Wait-list ControlAttention and ImpulsivityBaseline53.45 units on a scaleStandard Deviation 7.7
Wait-list ControlAttention and ImpulsivityAfter training56.17 units on a scaleStandard Deviation 9.31
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.

Time frame: Baseline, Immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupEmpathyBaseline1.53 units on a scaleStandard Deviation 0.36
Intervention GroupEmpathyAfter training1.41 units on a scaleStandard Deviation 0.44
Wait-list ControlEmpathyAfter training1.59 units on a scaleStandard Deviation 0.67
Wait-list ControlEmpathyBaseline1.47 units on a scaleStandard Deviation 0.91
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.

Time frame: Baseline, Immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupParent-reported AttentionAfter training3.54 score on a scaleStandard Deviation 0.71
Intervention GroupParent-reported AttentionBaseline3.58 score on a scaleStandard Deviation 0.43
Wait-list ControlParent-reported AttentionAfter training3.50 score on a scaleStandard Deviation 0.59
Wait-list ControlParent-reported AttentionBaseline3.46 score on a scaleStandard Deviation 0.62
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.

Time frame: baseline, immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupParent-reported ConductBaseline3.42 score on a scaleStandard Deviation 0.5
Intervention GroupParent-reported ConductAfter training3.58 score on a scaleStandard Deviation 0.61
Wait-list ControlParent-reported ConductAfter training3.54 score on a scaleStandard Deviation 0.35
Wait-list ControlParent-reported ConductBaseline3.63 score on a scaleStandard Deviation 0.63
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.

Time frame: Baseline, Immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupParent-reported Emotion RegulationAfter training3.88 score on a scaleStandard Deviation 0.43
Intervention GroupParent-reported Emotion RegulationBaseline3.88 score on a scaleStandard Deviation 0.4
Wait-list ControlParent-reported Emotion RegulationAfter training3.88 score on a scaleStandard Deviation 0.43
Wait-list ControlParent-reported Emotion RegulationBaseline3.81 score on a scaleStandard Deviation 0.55
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.

Time frame: Baseline, Immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupParent-reported Prosocial BehaviorAfter training4.00 score on a scaleStandard Deviation 0.36
Intervention GroupParent-reported Prosocial BehaviorBaseline3.67 score on a scaleStandard Deviation 0.36
Wait-list ControlParent-reported Prosocial BehaviorAfter training4.04 score on a scaleStandard Deviation 0.52
Wait-list ControlParent-reported Prosocial BehaviorBaseline4.08 score on a scaleStandard Deviation 0.43
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.

Time frame: Baseline, Immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupProsocial BehaviorBaseline1.38 score on a scaleStandard Deviation 0.92
Intervention GroupProsocial BehaviorAfter training1.50 score on a scaleStandard Deviation 0.76
Wait-list ControlProsocial BehaviorBaseline1.75 score on a scaleStandard Deviation 0.71
Wait-list ControlProsocial BehaviorAfter training1.50 score on a scaleStandard Deviation 0.76
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.

Time frame: Baseline, Immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupTeacher-reported AttentionBaseline4.17 score on a scaleStandard Deviation 0.61
Intervention GroupTeacher-reported AttentionAfter training4.63 score on a scaleStandard Deviation 0.28
Wait-list ControlTeacher-reported AttentionBaseline3.83 score on a scaleStandard Deviation 0.99
Wait-list ControlTeacher-reported AttentionAfter training4.13 score on a scaleStandard Deviation 0.56
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.

Time frame: baseline, immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupTeacher-reported ConductBaseline4.71 score on a scaleStandard Deviation 0.28
Intervention GroupTeacher-reported ConductWeew4.96 score on a scaleStandard Deviation 0.12
Wait-list ControlTeacher-reported ConductBaseline4.42 score on a scaleStandard Deviation 0.66
Wait-list ControlTeacher-reported ConductWeew4.46 score on a scaleStandard Deviation 0.47
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.

Time frame: baseline, immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupTeacher-reported Emotion RegulationBaseline4.71 score on a scaleStandard Deviation 0.45
Intervention GroupTeacher-reported Emotion RegulationAfter training4.96 score on a scaleStandard Deviation 0.12
Wait-list ControlTeacher-reported Emotion RegulationAfter training4.79 score on a scaleStandard Deviation 0.31
Wait-list ControlTeacher-reported Emotion RegulationBaseline4.33 score on a scaleStandard Deviation 0.87
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.

Time frame: baseline, immediately after intervention at Week 14

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupTeacher-reported Prosocial BehaviorBaseline3.79 score on a scaleStandard Deviation 0.36
Intervention GroupTeacher-reported Prosocial BehaviorAfter training4.00 score on a scaleStandard Deviation 0.36
Wait-list ControlTeacher-reported Prosocial BehaviorBaseline4.08 score on a scaleStandard Deviation 0.43
Wait-list ControlTeacher-reported Prosocial BehaviorAfter training4.04 score on a scaleStandard Deviation 0.52

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026