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

Seattle Children's Healthcare System

Status: Unknown

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Behavioral: Mindful sensory awareness + mindful body awareness check-ins intervention; Behavioral: Mindful sensory awareness intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04550507

R61AT009859 (U.S. NIH Grant/Contract)

STUDY00001443

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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75 participants in 2 patient groups

Group A: Mindful Sensory Awareness

Experimental group

Description:

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.

Treatment:

Behavioral: Mindful sensory awareness intervention

Group B: Mindful Sensory and Body Awareness

Other group

Description:

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.

Treatment:

Behavioral: Mindful sensory awareness + mindful body awareness check-ins intervention