Clinical trial NCT04550507: Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents
Official title: Mind-Body Interventions to Mitigate Effects of Media Use on Sleep (Sleepazoid Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of Washington
First posted: 2020-09-16
Enrollment: 75
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime
timeFrame: 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).
measure: state arousal measured by heart rate variability (HRV), beginning at usual bedtime
timeFrame: 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).
measure: state arousal measured by heart rate variability (HRV), when youth started trying to fall asleep
timeFrame: 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).
measure: state arousal measured by heart rate variability (HRV), during game play exposure
timeFrame: 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).
measure: state arousal measured by heart rate variability (HRV), during recovery period
timeFrame: 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).
Secondary outcomes:
measure: state arousal measured by electrodermal activity (EDA)
timeFrame: 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).
measure: PreSleep Arousal Scale, modified for Children (PSAS-C), remote assessment visits
timeFrame: 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).
measure: PreSleep Arousal Scale, modified for Children (PSAS-C), home measurement weeks
timeFrame: 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).
measure: mean sleep onset latency (SOL)
timeFrame: 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).
measure: mean sleep duration
timeFrame: 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).
measure: Adolescent Sleep Wake Scale (ASWS) total sleep scale score
timeFrame: 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).
measure: time to reach baseline arousal (HRV and EDA)
timeFrame: 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).
Other outcomes:
measure: Adolescent Sleep Hygiene Scale (ASHS) total sleep hygiene score
timeFrame: 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).
measure: Cleveland Adolescent Sleepiness Questionnaire (CASQ)
timeFrame: 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).
measure: MAIA-2
timeFrame: 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).
measure: Revised Child Anxiety and Depression Scale, short form (RCADS-25)
timeFrame: 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).
measure: average screentime blackout
timeFrame: 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).
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Michelle M Garrison, PhD
role: PRINCIPAL_INVESTIGATOR
References: