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Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents (Sleepazoid)

2020年10月22日 更新者:Michelle Garrison、Seattle Children's Hospital

Mind-Body Interventions to Mitigate Effects of Media Use on Sleep (Sleepazoid Study)

Eliminating media use is neither feasible at a public health level nor perhaps even desirable given the role it plays in the lives of youth and adults, but mind-body interventions have the potential to mitigate state arousal effects and thus reduce negative impacts on sleep. Given emerging literature on links between intensive media use, sensory and interoceptive awareness, and self-regulation, this study will examine two related mind-body approaches -- a mindfulness sensory awareness exercises and mindful body awareness check-ins -- in a randomized clinical trial of early adolescents with evening media use and sleep problems.

研究概览

研究类型

介入性

注册 (预期的)

75

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

11年 至 14年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Child age at enrollment is 11y0m to 14y11m
  • Child is in the 6th-8th grade, or during summer recruitment, will be so in the coming autumn.
  • Total score of 52 or higher on the Sleep Disturbances Scale for Children (SDSC), a parent-report survey questionnaire regarding child sleep health
  • Parent reports child has >= 1 hour of media use during the 3 hours before bed at least 4 nights per week.
  • Parent and child both are comfortable reading and hearing instructions in English and in answering surveys written in English.
  • Families must also have at least two internet-connected portable screen devices available - one which much be an iOS or Android tablet or smartphone device and which will be used to download the games used in the media-induced arousal task and then used to play those games with the device in airplane mode, and a second which will be used to connect to the study staff via video conference, and which can be a laptop computer, tablet, or smartphone.

Exclusion Criteria:

  • Untreated diagnosis (by parent report) or positive screen for sleep-disordered breathing on the SDSC parent report survey questionnaire
  • Current use of medications known to affect sleep (systemic corticosteroids, stimulants, melatonin) by parent report
  • Sleeps at a second residence from enrolling parent more than two nights a week according to parent report
  • Has a current serious chronic medical condition known to affect sleep and/or arousal patterns (such as cancer or diabetes) by parent report.
  • Currently engages in meditation or body scan to fall asleep, according to parent report

We exclude potential participants who meet one of the following criteria because of concerns that their heart rate variability response may be too atypical to be valuable in this protocol (ASD or developmental delay, eating disorder, PTSD, illicit drug use) and/or because of concerns that the associated behavioral challenges and/or instability would impair ability to adhere to the entire 4-6 month protocol.

  • Diagnosis of Autism Spectrum Disorder or developmental delay by parent self-report
  • Current diagnosis of eating disorder by parent self-report
  • Current diagnosis of PTSD by parent self-report
  • Illicit drug use within the last three months by parent self-report
  • Is currently suicidal, based on the ASQ (Ask Suicide Screening Questions)
  • Hospitalization for depression or anxiety in the last year by parent self-report; or severe current depression symptoms as indicated by a t-score > 80 on the RCADS-25. We will also exclude those with last year hospitalization, regardless of symptom score, because this is often an indicator of instability and undertreatment, and ability to adhere to the entire 4-6 month protocol would likely be impaired.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Group A: Mindful Sensory Awareness
Group A: Mindful Sensory Awareness receives the mindful sensory awareness intervention during the first 8-week period, and receives no active intervention delivery during the second 8-week period.
The mindfulness sensory awareness exercise will be a brief (3-5 minutes), guided meditation focusing on sensory and interoceptive awareness developed by Co-I Price, modified slightly to meet the needs of this age group and targeted for attention to indicators of fatigue or a sense of overstimulation. Youth will be asked to use the exercise after ending media use but before trying to sleep. The meditation component will be delivered via an audio-guided MP3, along with illustrated instructions in both handout and video, and a guided workbook that coaches youth over the 8-week intervention period to practice their skills, reflect on their experiences, and maintain adherence.
其他:Group B: Mindful Sensory and Body Awareness
Group B: Mindful Sensory and Body Awareness receives no active intervention delivery during the first 8-week period, and during the second 8-week period receives an intervention combining the mindful sensory awareness content received by Group A with the mindful body awareness check-in approach.
During the intervention period for Group B: Mindful Sensory & Body Awareness(the second 8 weeks), they will receive the same mindful sensory awareness intervention, and also learn the mindful body awareness check-ins to guide media use choices strategy (referred to here as the check-ins component). We will coach youth to pause briefly every 30 minutes during media use to discern if they detect physical, cognitive, or emotional signs of escalated state arousal, and to make an intentional and real-time choice about possible changes in media use content or duration to help decrease state arousal levels before bed.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).

HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).

HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at 30 minutes prior to usual bedtime.

At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
state arousal measured by heart rate variability (HRV), beginning at usual bedtime
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).

HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).

HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at usual bedtime.

At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
state arousal measured by heart rate variability (HRV), when youth started trying to fall asleep
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).

HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).

HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning when the youth reported on the diary starting to try to fall asleep.

At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
state arousal measured by heart rate variability (HRV), during game play exposure
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).

HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).

HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods during the remote assessment visit during the last 5 minutes of the game play exposure.

At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
state arousal measured by heart rate variability (HRV), during recovery period
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).

HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals).

HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods during the remote assessment visit during the last 5 minutes of the recovery period post-exposure.

At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).

次要结果测量

结果测量
措施说明
大体时间
state arousal measured by electrodermal activity (EDA)
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
The Empatica E4 wrist-worn wireless telemetry device also measures electrodermal activity (EDA) in µSiemens, sampled at 4Hz. EDA will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods per measurement night at each of the following time periods, both in the home measurement weeks: a) beginning at 30 minutes prior to usual bedtime, b) beginning at usual bedtime, and c) beginning when the youth reported starting to try to fall asleep, with (b) and (c) being further apart on nights with greater behavioral bedtime delay, and in the remote assessments: d) in the last 5 minutes of the game play exposure, and e) in the last 5 minutes of the recovery period post-exposure.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
PreSleep Arousal Scale, modified for Children (PSAS-C), remote assessment visits
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
The PSAS-C (PreSleep Arousal Scale, modified for Children) is a 16-item scale that has been successfully used to assess perceived cognitive and somatic arousal at bedtime in children ages 8-14; and the adult version (PSAS) has been shown to be a significant mediator of the relationship between evening media use and sleep in adolescents and young adults, and been used to test state arousal mechanisms of mindfulness interventions on sleep. Youth will complete this at the end of the post-exposure recovery period during each remote assessment visit. Possible scores range from 16-80, with higher scores indicating worse pre-sleep arousal levels.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
PreSleep Arousal Scale, modified for Children (PSAS-C), home measurement weeks
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
The PSAS-C (PreSleep Arousal Scale, modified for Children) is a 16-item scale that has been successfully used to assess perceived cognitive and somatic arousal at bedtime in children ages 8-14; and the adult version (PSAS) has been shown to be a significant mediator of the relationship between evening media use and sleep in adolescents and young adults, and been used to test state arousal mechanisms of mindfulness interventions on sleep. Youth will complete this each night during all home measurement weeks as part of the sleep diary, and the mean result across the week will be used. Possible scores range from 16-80, with higher scores indicating worse pre-sleep arousal levels.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
mean sleep onset latency (SOL)
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
time from diary-reported "going to bed" time to diary-reported time of sleep onset, averaged across one week
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
mean sleep duration
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
diary-reported time of sleep onset to diary-reported time of sleep offset, averaged across one week
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Adolescent Sleep Wake Scale (ASWS) total sleep scale score
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
The ASWS (Adolescent Sleep Wake Scale) is a symptom scale of behavioral sleep problems common across pre-adolescence and adolescence, chosen because it does not focus on school days (and so appropriate year-round) and is written at Flesch-Kincaid Grade 4.5. Possible scores range from 5-30, with higher scores indicating better sleep.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
time to reach baseline arousal (HRV and EDA)
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
We will also evaluate the time to reach baseline state arousal levels (via HRV and EDA) after ceasing evening media use will be decreased in the intervention compared to the control group, in both remote assessment visit and home measurement week settings.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).

其他结果措施

结果测量
措施说明
大体时间
Adolescent Sleep Hygiene Scale (ASHS) total sleep hygiene score
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
The ASHS (Adolescent Sleep Hygiene Scale) is a scale measuring environmental and behavioral factors contributing to sleep problems common across pre-adolescence and adolescence, chosen because it does not focus on school days (and so appropriate year-round) and is written at Flesch-Kincaid Grade 4.5. It is collected via youth self-report surveys. Possible scores range from 8-48, with higher scores indicating better sleep hygiene.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Cleveland Adolescent Sleepiness Questionnaire (CASQ)
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Survey instrument to measure excessive daytime sleepiness in adolescent, collected via youth self-report surveys. Possible scores range from 0-80, with higher scores indicating worse daytime sleepiness.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
MAIA-2
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
This is a tool for evaluating interoceptive awareness, with subscales for noticing body sensations, attention regulation to body sensations, awareness of emotion signals in body sensations, etc. It is collected via youth self-report surveys. Possible scores range from 0-40, with higher scores indicating greater levels of positive awareness.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
Revised Child Anxiety and Depression Scale, short form (RCADS-25)
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
This is a survey tool for assessing parent and youth report of anxiety and depression symptoms in the youth, collected via youth self-report surveys. Possible scores range from 0-75, with higher scores indicating more severe levels of anxiety and depression symptoms.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
average screentime blackout
大体时间:At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
This will be measured as the average time across a diary week at which a youth discontinued media use for the night. If the youth fell asleep while using media use, the time of sleep onset is used.
At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michelle M Garrison, PhD、Seattle Children's Research Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年10月22日

初级完成 (预期的)

2021年8月1日

研究完成 (预期的)

2021年10月1日

研究注册日期

首次提交

2020年8月28日

首先提交符合 QC 标准的

2020年9月8日

首次发布 (实际的)

2020年9月16日

研究记录更新

最后更新发布 (实际的)

2020年10月26日

上次提交的符合 QC 标准的更新

2020年10月22日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • STUDY00001443
  • R61AT009859 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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