Sustainable Habits for Encouraging Even Teen Sleep

Not Applicable

Completed

• Conditions: Psychiatric Health; Sleep
• Interventions: Behavioral: Garmin, Pattern Health App

• Registration Number: NCT05378373
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Study Start: 2022-10-21
• Status Verified: 2024-07
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• ages 12-14 years
• parent concern on the routines/consistency subscale of the Pediatric Sleep Practices Questionnaire, indicating poor sleep practices (score of 2) in at least one of the following: bedtime consistency, wake time consistency, and bedtime routines;
• ability to speak, read and write in English
• access to internet and smartphone device with capacity to download intervention App (iOS and Android)
• valid email address
• ability to follow written and verbal instructions
• ability and willingness to comply with study procedures.

Exclusion Criteria

• diagnosed sleep disorder
• psychiatric disorder under treatment (medication and/or therapy) or intellectual disability
• chronic pain condition interfering with sleep
• substance use disorder
• use of medication for sleep (prescription or over-the-counter)
• has a sibling also enrolled/participating in the same study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHEETS Arm 1	Garmin, Pattern Health App	Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
SHEETS Arm 2	Garmin, Pattern Health App	Participants will receive sleep education-related content to support good sleep, like setting schedules.

Primary Outcome Measures

Name	Time	Method
Feasibility as measured by Retention Rate	6 months	The number of participants who return for each sleep regularity assessment divided by the number who were eligible upon completion of the baseline assessment.
Acceptability as measured by activity completion	6 months	The number of participants who complete all weekly sessions divided by the total number of weekly sessions.
Change in Sleep Regularity Index (SRI)	baseline, 6 weeks, 3 months, 6 months	A measure of sleep regularity collected continuously over 7 days via Actigraphy. The SRI is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status
Feasibility as measured by Recruitment rate	6 months	The number of participants consenting (and assenting) divided by the number who were invited.

Secondary Outcome Measures

Name	Time	Method
Sleep Regularity Index (SRI) as measured by Garmin	6 weeks	A measure of sleep regularity collected continuously over 6 weeks via Garmin. The SRI is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status
Change in Self-Reported Sleep Health	baseline, 6 weeks, 3 months, 6 months	Self-reported sleep will be assessed via the PROMIS pediatric sleep survey, a 5-point Likert scale ranging from Never to Always. Lower scores indicate better outcomes.
Change in Parent Reported Psychiatric Health	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. Lower scores indicate better outcomes.
Change in Adolescent Reported Psychiatric Health	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. Lower scores indicate better outcomes.

Trial Locations

Locations (1)

Duke Children's Primary Care North Durham; 🇺🇸 Durham, North Carolina, United States