Duke Children's Primary Care North Durham
Durham, North Carolina, 27704, United States
NCT Number: NCT05378373
This study will examine the feasibility, acceptability, and effectiveness of two digital sleep interventions in improving sleep regularity and psychiatric health during a critical period of adolescence.
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Notify Me12 year–14 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27704, United States
This study will be testing two digital sleep health interventions for adolescents. Adolescents in both conditions will receive sleep education-related content. This project also uses an innovative digital platform and wearable sensors to deliver feedback.
The purpose of this research study is to evaluate a 6-week digital sleep intervention to promote healthy sleep patterns. The study will be broken up into two phases: Phase 1: Focus group participation. Participants and their guardian will be asked to participate in a focus group to get their thoughts/opinions on the intervention. Phase 2: Participants and their guardian will be asked to come to 4 different study visits: baseline, post-intervention, 3 month and 6 month follow up. Participants will be asked to complete questionnaires about demographics, psychiatric health, and sleep patterns. The participants will be asked to wear an ActiGraph watch for 24hrs/day for a week for 4 separate weeks, a Garmin for the duration of the 6-week intervention and keep a sleep diary through an online program.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
Time frame: Baseline, 6 weeks, 3 months, 6 months
A measure of sleep regularity collected continuously over 7 days via actigraphy. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity.
Time frame: 6 months
The number of participants consenting (and assenting) divided by the number who were invited (i.e., passed the telephone prescreen) x 100 to produce a percentage.
Time frame: 6 weeks, 3 months, 6 months
Time frame: 6 weeks
Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100.
Time frame: Baseline, 6 weeks, 3 months, 6 months
Self-reported sleep will be assessed via the PROMIS pediatric sleep disturbances survey, an 8 item survey (each item is on a 5-point Likert scale ranging from Never to Always). The total score ranges from 0 to 32, where lower scores indicate better outcomes.
Time frame: Baseline, 6 weeks, 3 months, 6 months
As measured by the Youth Self Report, a 112-item questionnaire, with a 3-point Likert scale ranging from Not True to Very True. The internalizing subscale is based on 31 items. The standardized T-score has a population mean of 50 with a standard deviation of 10. Lower scores indicate better outcomes.
Time frame: Baseline, 6 weeks, 3 months, 6 months
As measured by the Child Behavior Checklist, a 112-item questionnaire, with a 3-point Likert scale ranging from Not True to Very True. The internalizing subscale is based on 31 items. The standardized T-score has a population mean of 50 with a standard deviation of 10. Lower scores indicate better outcomes.
Time frame: 6 weeks
A measure of sleep regularity collected continuously over 7 days via Garmin. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity.
Duke University
Other
Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep and Psychiatric Health in Adolescents
Acronym: SHEETS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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