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临床试验/NCT03989934
NCT03989934已完成不适用

Optimizing a Mindful Intervention for Urban Minority Youth Via Stress Physiology

Penn State University1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2019年2月5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
203
试验地点
1
主要终点
Heart rate variability (HRV)

研究概览

简要总结

This study evaluates the effects of mindfulness on physiological stress mechanisms implicated in externalizing behaviors and symptoms of affective and traumatic stress among urban adolescents. Program effects on stress physiology will be evaluated using pre- and post-tests of heart rate variability (HRV) during a stress task. Emotional and behavioral outcomes will be measured using student and teacher ratings.

详细描述

Low-income urban adolescents experience high rates of adversity and trauma exposure, increasing their risk for stress-related problems, including externalizing behaviors and affective and traumatic stress symptoms. These outcomes are associated with dysregulated physiological responses to stress, both in the laboratory and real-world contexts. The neuroplasticity that typifies adolescence heightens vulnerability to stress effects on various brain and body systems. On the other hand, the same neurodevelopmental features also suggest pathways for overcoming and altering stymied trajectories through targeted interventions that leverage the brain's plasticity. Thus, adolescence affords a window of opportunity to reinforce parasympathetic modulation of stress responses, enhancing capacities for emotion regulation and, in effect, protecting against the development of behavioral and affective problems.

There is growing empirical support for the ability of mindfulness-based programs to improve stress management in adults, leading to improved well-being, coping and prosocial behavior. Evidence suggests that mindfulness influences homeostatic systems that modulate neurophysiological responses to stress in the service of emotion regulation. Indeed, neuroimaging studies in adults have established that mindfulness measurably improves brain function, demonstrating the alterability of these mechanisms. No such data have been collected for youth, nor have the psychophysiological mechanisms underlying mindfulness program effects for disadvantaged urban youth been rigorously evaluated. The proposed research thus has potential to substantively advance understanding of mindfulness mechanisms of effects and also to facilitate optimization of mindfulness programming so that it has maximum benefits for urban youth.

This study evaluates the effects of mindfulness on physiological stress mechanisms implicated in externalizing behaviors and symptoms of affective and traumatic stress among urban adolescents. Program effects on stress physiology will be evaluated using pre- and post-tests of heart rate variability (HRV) during a stress task. Emotional and behavioral outcomes will be measured using student and teacher ratings.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Must be in the 9th grade at one of the Baltimore City Public Schools participating in the study
  • •Must provide parental permission and assent.

排除标准

  • •Students in foster care
  • •Students in self-contained special education classrooms

研究组 & 干预措施

The Mind in Action

Experimental

The Mind in Action is a mindfulness intervention developed by the Holistic Life Foundation (HLF), a Baltimore-based non-profit organization. The curriculum will be delivered over approximately 40 sessions and will follow HLF's typical program modifications for high school students (i.e., sustained focus on breath work and meditation). Each program session will include an initial exercise of focusing on the breath to center oneself, followed by the introduction and practice of different breathing techniques (e.g., rhythmic breathing) that enhance calmness and reduce physiological arousal, and concluding with a brief guided meditation. Instructors will describe benefits of the practices for health and stress management. Participants are given assignments between sessions to reinforce lessons (e.g., breathing exercises or periods of meditation).

干预措施: The Mind in Action (Behavioral)

Healthy Topics

Active Comparator

Adapted from the Glencoe Health Curriculum (McGraw Hill), Healthy Topics is designed to control for the effects of a positive adult, time and attention, a small group learning environment, engaged instruction, and interesting material. The Healthy Topics curriculum has been successfully implemented as an effective active control condition, with student engagement and participation comparable to the intervention arm. The curriculum includes information about nutrition, exercise, sleep, drug use, and other topics related to physical health.

干预措施: Healthy Topics (Behavioral)

结局指标

主要结局

Heart rate variability (HRV)

时间窗: 25 minutes

HRV is a biomarker of neural regulation of the autonomic nervous system (ANS) and reflects activity in the parasympathetic (PNS) division. HRV is perturbed by stress and can be altered long-term when adversity is prevalent. As such, it has been associated with symptoms of affective and traumatic stress disorders and externalizing behaviors. We will non-invasively monitor the reactivity of HRV using an earlobe sensor to index the PNS. Participants will complete the Trier Social Stress Task (TSST), which is a standard protocol for inducing moderate psychosocial stress in laboratory settings, and has been widely used with preadolescents and adolescents (Gunnar, Wewerka, Frenn, Long, \& Griggs, 2009; Kirschbaum, Pirke, \& Hellhammer, 1993). The protocol involves preparing and delivering a speech by the participant in the presence of an adult experimenter and while being videotaped. The trained research assistant is instructed to be as non-responsive as possible during the task.

次要结局

  • Background Questionnaire(3 minutes)
  • Youth Risk Behavior Survey(10 minutes)
  • Strengths and Difficulties Questionnaire(8 minutes)
  • Patient-Reported Outcomes Measurement Information System(6 minutes)
  • Adverse Childhood Experiences Checklist(3 minutes)
  • Child Behavior Checklist:(10 minutes)
  • Child PTSD Symptom Scale(3 minutes)
  • Emotion Regulation Questionnaire(3 minutes)
  • Brief COPE(5 minutes)
  • Perceived Stress Scale(3 minutes)
  • Child and Adolescent Mindfulness Measure(3 minutes)

研究者

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

Diana Fishbein

Professor, Department of Human Development and Family Studies

Penn State University

研究点 (1)

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