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临床试验/NCT05058365
NCT05058365Unknown不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
16
试验地点
1
主要终点
Attention and Impulsivity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Attention and Impulsivity

时间窗: Baseline, Immediately after intervention at Week 14

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.

Empathy

时间窗: Baseline, Immediately after intervention at Week 14

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.

Prosocial Behavior

时间窗: Baseline, Immediately after intervention at Week 14

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.

Parent-reported Attention

时间窗: Baseline, Immediately after intervention at Week 14

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.

Parent-reported Emotion Regulation

时间窗: Baseline, Immediately after intervention at Week 14

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.

Parent-reported Prosocial Behavior

时间窗: Baseline, Immediately after intervention at Week 14

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.

Parent-reported Conduct

时间窗: baseline, immediately after intervention at Week 14

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.

Teacher-reported Attention

时间窗: Baseline, Immediately after intervention at Week 14

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.

Teacher-reported Emotion Regulation

时间窗: baseline, immediately after intervention at Week 14

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.

Teacher-reported Prosocial Behavior

时间窗: baseline, immediately after intervention at Week 14

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.

Teacher-reported Conduct

时间窗: baseline, immediately after intervention at Week 14

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Lam Shui-fong

Director

The University of Hong Kong

研究点 (1)

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