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

Status unconfirmed · Not applicable

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

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.

Key facts

Study ID: NCT04550507
Run by: Seattle Children's Hospital
People needed: 75
Starts: 2020-10-22
Expected to finish: 2021-10-01
Last updated by the study team: 2020-10-26

Who can join

Age: 11 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Seattle Children's Research Institute — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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