Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents (Sleepazoid)
22 ottobre 2020 aggiornato da: Michelle Garrison, Seattle Children's Hospital
Mind-Body Interventions to Mitigate Effects of Media Use on Sleep (Sleepazoid Study)
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.
Panoramica dello studio
Stato
Sconosciuto
Tipo di studio
Interventistico
Iscrizione (Anticipato)
75
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Clinical Research Coordinator
- Numero di telefono: (206) 884-1422
- Email: Sleepazoid@seattlechildrens.org
Backup dei contatti dello studio
- Nome: Michelle M Garrison, PhD
- Email: michelle.garrison@seattlechildrens.org
Luoghi di studio
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Washington
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Seattle, Washington, Stati Uniti, 98121
- Reclutamento
- Seattle Children's Research Institute
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Contatto:
- Michelle M Garrison, PhD
- Email: michelle.garrison@seattlechildrens.org
-
Contatto:
- Clinical Research Coordinator
- Numero di telefono: 206-884-1422
- Email: Sleepazoid@seattlechildrens.org
-
Investigatore principale:
- Michelle M Garrison, PhD
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 11 anni a 14 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Altro: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime
Lasso di tempo: 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).
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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).
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state arousal measured by heart rate variability (HRV), beginning at usual bedtime
Lasso di tempo: 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).
|
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).
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state arousal measured by heart rate variability (HRV), when youth started trying to fall asleep
Lasso di tempo: 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).
|
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).
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state arousal measured by heart rate variability (HRV), during game play exposure
Lasso di tempo: 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).
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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).
|
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state arousal measured by heart rate variability (HRV), during recovery period
Lasso di tempo: 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).
|
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).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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state arousal measured by electrodermal activity (EDA)
Lasso di tempo: 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).
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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.
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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).
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PreSleep Arousal Scale, modified for Children (PSAS-C), remote assessment visits
Lasso di tempo: 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).
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The PSAS-C (PreSleep Arousal Scale, modified for Children) is a 16-item scale that has been successfully used to assess perceived cognitive and somatic arousal at bedtime in children ages 8-14; and the adult version (PSAS) has been shown to be a significant mediator of the relationship between evening media use and sleep in adolescents and young adults, and been used to test state arousal mechanisms of mindfulness interventions on sleep.
Youth will complete this at the end of the post-exposure recovery period during each remote assessment visit.
Possible scores range from 16-80, with higher scores indicating worse pre-sleep arousal levels.
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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).
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PreSleep Arousal Scale, modified for Children (PSAS-C), home measurement weeks
Lasso di tempo: 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).
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The PSAS-C (PreSleep Arousal Scale, modified for Children) is a 16-item scale that has been successfully used to assess perceived cognitive and somatic arousal at bedtime in children ages 8-14; and the adult version (PSAS) has been shown to be a significant mediator of the relationship between evening media use and sleep in adolescents and young adults, and been used to test state arousal mechanisms of mindfulness interventions on sleep.
Youth will complete this each night during all home measurement weeks as part of the sleep diary, and the mean result across the week will be used.
Possible scores range from 16-80, with higher scores indicating worse pre-sleep arousal levels.
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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).
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mean sleep onset latency (SOL)
Lasso di tempo: 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).
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time from diary-reported "going to bed" time to diary-reported time of sleep onset, averaged across one week
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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).
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mean sleep duration
Lasso di tempo: 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).
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diary-reported time of sleep onset to diary-reported time of sleep offset, averaged across one week
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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).
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Adolescent Sleep Wake Scale (ASWS) total sleep scale score
Lasso di tempo: 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).
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The ASWS (Adolescent Sleep Wake Scale) is a symptom scale of behavioral 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.
Possible scores range from 5-30, with higher scores indicating better sleep.
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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).
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time to reach baseline arousal (HRV and EDA)
Lasso di tempo: 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).
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We will also evaluate the time to reach baseline state arousal levels (via HRV and EDA) after ceasing evening media use will be decreased in the intervention compared to the control group, in both remote assessment visit and home measurement week settings.
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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).
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Adolescent Sleep Hygiene Scale (ASHS) total sleep hygiene score
Lasso di tempo: 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).
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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.
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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).
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Cleveland Adolescent Sleepiness Questionnaire (CASQ)
Lasso di tempo: 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).
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Survey instrument to measure excessive daytime sleepiness in adolescent, collected via youth self-report surveys.
Possible scores range from 0-80, with higher scores indicating worse daytime sleepiness.
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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).
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MAIA-2
Lasso di tempo: 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).
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This is a tool for evaluating interoceptive awareness, with subscales for noticing body sensations, attention regulation to body sensations, awareness of emotion signals in body sensations, etc.
It is collected via youth self-report surveys.
Possible scores range from 0-40, with higher scores indicating greater levels of positive awareness.
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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).
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Revised Child Anxiety and Depression Scale, short form (RCADS-25)
Lasso di tempo: 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).
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This is a survey tool for assessing parent and youth report of anxiety and depression symptoms in the youth, collected via youth self-report surveys.
Possible scores range from 0-75, with higher scores indicating more severe levels of anxiety and depression symptoms.
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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).
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average screentime blackout
Lasso di tempo: 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).
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This will be measured as the average time across a diary week at which a youth discontinued media use for the night.
If the youth fell asleep while using media use, the time of sleep onset is used.
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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).
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Michelle M Garrison, PhD, Seattle Children's Research Institute
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
22 ottobre 2020
Completamento primario (Anticipato)
1 agosto 2021
Completamento dello studio (Anticipato)
1 ottobre 2021
Date di iscrizione allo studio
Primo inviato
28 agosto 2020
Primo inviato che soddisfa i criteri di controllo qualità
8 settembre 2020
Primo Inserito (Effettivo)
16 settembre 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 ottobre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 ottobre 2020
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00001443
- R61AT009859 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .