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Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents | Clinical Trials | Clareo Health

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

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

NCT04550507•Seattle Children's Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

11 - 14 years

Sex

ALL

Healthy Volunteers

Yes

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
+2 more criteria

Locations (1)

Seattle Children's Research Institute

Seattle, Washington, United States

Key Dates

Start Date

October 22, 2020

Primary Completion Date

August 1, 2021

Completion Date

October 1, 2021

Last Updated

October 26, 2020

Enrollment

ESTIMATED participants

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mindful sensory awareness intervention

BEHAVIORAL

Mindful sensory awareness + mindful body awareness check-ins intervention

BEHAVIORAL

Contacts

Clinical Research Coordinator

CONTACT

(206) 884-1422 Sleepazoid@seattlechildrens.org

Michelle M Garrison, PhD

CONTACT

michelle.garrison@seattlechildrens.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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