Mind-Body Interventions to Mitigate Effects of Media Use... | NCT04550507

ID	Type	Description	Link
R61AT009859	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH
University of Washington	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: Mindful Sensory Awareness	Experimental	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.	Behavioral: Mindful sensory awareness intervention
Group B: Mindful Sensory and Body Awareness	Other	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.	Behavioral: Mindful sensory awareness + mindful body awareness check-ins intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindful sensory awareness intervention	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime	HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at 30 minutes prior to usual bedtime.	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).
state arousal measured by heart rate variability (HRV), beginning at usual bedtime	HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at usual bedtime.	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).
state arousal measured by heart rate variability (HRV), when youth started trying to fall asleep	HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning when the youth reported on the diary starting to try to fall asleep.

Secondary Outcomes

Measure	Description	Time Frame
state arousal measured by electrodermal activity (EDA)	The Empatica E4 wrist-worn wireless telemetry device also measures electrodermal activity (EDA) in µSiemens, sampled at 4Hz. EDA will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods per measurement night at each of the following time periods, both in the home measurement weeks: a) beginning at 30 minutes prior to usual bedtime, b) beginning at usual bedtime, and c) beginning when the youth reported starting to try to fall asleep, with (b) and (c) being further apart on nights with greater behavioral bedtime delay, and in the remote assessments: d) in the last 5 minutes of the game play exposure, and e) in the last 5 minutes of the recovery period post-exposure.

Other Outcomes

Measure	Description	Time Frame
Adolescent Sleep Hygiene Scale (ASHS) total sleep hygiene score	The ASHS (Adolescent Sleep Hygiene Scale) is a scale measuring environmental and behavioral factors contributing to sleep problems common across pre-adolescence and adolescence, chosen because it does not focus on school days (and so appropriate year-round) and is written at Flesch-Kincaid Grade 4.5. It is collected via youth self-report surveys. Possible scores range from 8-48, with higher scores indicating better sleep hygiene.

Eligibility Module

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.

Name	Role	Phone	Extension	Email
Clinical Research Coordinator	Contact	(206) 884-1422		Sleepazoid@seattlechildrens.org
Michelle M Garrison, PhD	Contact			michelle.garrison@seattlechildrens.org

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders