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临床试验/NCT02493218
NCT02493218已完成不适用

D-Stress Baltimore: School-based Mindfulness Instruction for Primary Prevention of Mental Health and Behavioral Problems in Middle School

Johns Hopkins University6 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
6
主要终点
Depressive symptoms

研究概览

简要总结

Effective strategies to ameliorate the negative effects of stressful urban living are greatly needed. D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program of stress-reduction techniques, found to reduce mental health problems across many adult populations.

The investigators propose to conduct a randomized controlled trial of the 12-week school-based DSB program compared with a 12-week school-based health education control program at Elev8 schools among 5th-8th graders to assess if DSB program is beneficial for mental health and behavioral problems among public middle-school students.

详细描述

Urban youth in Baltimore City are under significant and inevitable stresses, including violent neighborhoods, failing schools, and interpersonal conflict. Effective strategies to ameliorate the negative effects of stressful urban living are greatly needed.

D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program of stress-reduction techniques which has been found to be beneficial for adults in decreasing anxiety and depression, improving positive emotions, and reducing anger.

The investigators propose to conduct a randomized controlled trial of the 12-week school-based DSB program compared with a 12-week school-based health education control program at Elev8 schools among 5th-8th graders. The investigators hypothesize that the D-Stress Baltimore Program will reduce negative emotions, including hostility, and improve coping.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 5th - 8th graders in select Baltimore City schools

排除标准

  • 未提供

研究组 & 干预措施

Mindfulness Instruction

Experimental

Instruction on mindfulness concepts and practices. Classes are 45-90 minutes each and held weekly for 12 weeks.

干预措施: Mindfulness Instruction (Behavioral)

Health Education Instruction

Active Comparator

Instruction on general health and wellness. Classes are 45-90 minutes each and held weekly for 12 weeks.

干预措施: Health Education (Behavioral)

结局指标

主要结局

Depressive symptoms

时间窗: 9 months

Assessment of impact of Mindfulness instruction versus Health Education instruction as measured by scores on mental health questionnaire administered at baseline, and then 3 and 9 months later. Children's Depression Inventory - Short Form (CDI-S)

Affect Measures: Positive and Negative Affect Scale; State Trait Anger Expressivity Index; Differential Emotions Scale

时间窗: 9 months

Assessment of impact of Mindfulness instruction versus Health Education instruction as measured by scores on mental health questionnaire administered at baseline, and then 3 and 9 months later.

Anxiety assessed by Multidimensional Anxiety Scale of Childhood.

时间窗: 9 months

Assessment of impact of Mindfulness instruction versus Health Education instruction as measured by scores on mental health questionnaire administered at baseline, and then 3 and 9 months later.

次要结局

  • Coping Questionnaire(9 months)
  • Post-traumatic stress symptoms(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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