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

NCT04550507 | Unknown DMC

• 2 other identifiers: STUDY00001443R61AT009859
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (5)

• 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.

  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), during game play exposure

  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 during the remote assessment visit during the last 5 minutes of the game play exposure.

  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), during recovery period

  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 during the remote assessment visit during the last 5 minutes of the recovery period post-exposure.

  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 (7)

• state arousal measured by electrodermal activity (EDA)

  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).

• PreSleep Arousal Scale, modified for Children (PSAS-C), remote assessment visits

  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).

• PreSleep Arousal Scale, modified for Children (PSAS-C), home measurement weeks

  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).

• mean sleep onset latency (SOL)

  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).

• mean sleep duration

  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 (5)

• Adolescent Sleep Hygiene Scale (ASHS) total sleep hygiene score

  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).

• Cleveland Adolescent Sleepiness Questionnaire (CASQ)

  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).

• MAIA-2

  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).

Study Arms (2)

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

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.

Group A: Mindful Sensory Awareness

Mindful sensory awareness + mindful body awareness check-ins intervention BEHAVIORAL

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.

Group B: Mindful Sensory and Body Awareness

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Washington: collaborator

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98121, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Michelle M Garrison, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

(206) 884-1422; Sleepazoid@seattlechildrens.org

Michelle M Garrison, PhD

CONTACT

michelle.garrison@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 16, 2020
• Study Start: October 22, 2020
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

US (1)