Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents
NCT ID: NCT04550507
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2020-10-22
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
Mindful sensory awareness intervention
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.
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.
Mindful sensory awareness + mindful body awareness check-ins intervention
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.
Interventions
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Mindful sensory awareness intervention
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.
Mindful sensory awareness + mindful body awareness check-ins intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
11 Years
14 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Washington
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Michelle Garrison
Investigator
Principal Investigators
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Michelle M Garrison, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
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Seattle Children's Research Institute
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00001443
Identifier Type: -
Identifier Source: org_study_id