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临床试验/NCT05787483
NCT05787483已完成不适用

Evaluating Biopsychosocial Outcomes of Mindfulness-based Instruction in Adolescence

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年8月14日最近更新:
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
68
试验地点
1
主要终点
Anxiety - change

研究概览

简要总结

Over 20% of adolescents living in the United States have a diagnosable psychiatric disorder. However, most adolescents who need mental health services do not receive them due to many reasons, including low resources in families and communities, stigma, lack of mental health providers, and other barriers to mental health care access. Alabama currently ranks 50th in access to mental healthcare and 51st (LAST) in mental healthcare provider availability with only one mental healthcare provider for every 920 persons in need. Most adolescents attend school, so delivering mental health services in the school setting eliminates many barriers to mental health care access. From the point of prevention, participation in universal social and emotional learning (SEL) programs within the school setting improves social and emotional skills, behaviors, attitudes, and academic performance. Mindfulness-based instruction is a promising approach to SEL for improving psychological functioning that is evidence-based, widely available, and scalable to various populations and settings. This project aims to investigate whether a SEL program that incorporates mindfulness-based instruction (MindUP) leads to improvements in not only self-reported well-being (i.e., anxiety, mindful attention, perceived stress, and positive and negative affect), but also objectively measured executive functioning, academic achievement, and regulation of stress physiology. The investigators will partner with schools that serve historically underserved students to test the effectiveness of the MindUP program in 5th and 6th graders. This study has the potential to benefit underserved students and their teachers who will receive training on sustainable implementation of the MindUP curriculum.

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
None

盲法说明

No masking

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Fifth grade students at i3 Academy
  • •fifth and sixth grade students at Tarrant Intermediate School
  • •6th through 8th grade students at Spring Valley School
  • •All students enrolled in general education will be invited to participate in the study

排除标准

  • •those with medical, developmental, or psychiatric conditions that compromise their ability to provide valid self-reports or complete other study procedures
  • •only one child per family will be allowed to participate to avoid dependency in data due to clustering within families

研究组 & 干预措施

MindUP group

Experimental

Teachers in the MindUP group will deliver the program lessons twice a week for 30 minutes (1 hour per week) for 12 weeks. Based on previous studies, 12 weeks should be sufficient to cover the content from the 17 lessons.

干预措施: MindUP group (Behavioral)

active control group

Active Comparator

business as usual; regular wellness or SEL classes

干预措施: active control group (Behavioral)

结局指标

主要结局

Anxiety - change

时间窗: Five times: baseline (prior to start of the program), week 4, week 8, after the completion of the program, and a three-month follow-up

Autonomic reactions subscale of Children's Test Anxiety Scale (CTAS): has 9-items that ask the students to respond in terms of how they think, feel, or act during a test. All the questions start with the same stem, ''While I am taking tests…'' (e.g., "I feel nervous"; "My head hurts"). Students are asked to choose between four response options (i.e., almost never, 1; some of the time, 2; most of the time, 3; almost always, 4).

Mindful attention - change

时间窗: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up

Mindful Attention Awareness Scale-Children (MAAS-C): has 15 items and measures the frequency of mindful states over time. Students are asked to rate how frequently they experience certain state in a 6-point Likert scale ranging from almost never to almost always (e.g., "I could be feeling a certain way and not realize it until later"; "I break or spill things because of carelessness, not paying attention, or thinking of something else").

Anxiety - change

时间窗: Five times: baseline (prior to start of the program), week 4, week 8, after the completion of the program, and a three-month follow-up

Autonomic reactions subscale of Children's Test Anxiety Scale (CTAS): has 9-items that ask the students to respond in terms of how they think, feel, or act during a test. All the questions start with the same stem, ''While I am taking tests…'' (e.g., "I feel nervous"; "My head hurts"). Students are asked to choose between four response options (i.e., almost never, 1; some of the time, 2; most of the time, 3; almost always, 4).

Mindful attention - change

时间窗: Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up

Mindful Attention Awareness Scale-Children (MAAS-C): has 15 items and measures the frequency of mindful states over time. Students are asked to rate how frequently they experience certain state in a 6-point Likert scale ranging from almost never to almost always (e.g., "I could be feeling a certain way and not realize it until later"; "I break or spill things because of carelessness, not paying attention, or thinking of something else").

次要结局

  • Stress self-report - change(Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up)
  • Positive and negative affect - change(12 times - once per week)
  • C-reactive protein (CRP) - change(Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up)
  • Cortisol - change(Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up)
  • Dehydroepiandrosterone (DHEA) - change(Five times: baseline (prior to start of the program), week 4, week 8, immediately after the completion of the program (week 13), and a three-month follow-up)

研究者

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

Caroline G. Richter

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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