Sustainable Habits for Encouraging Even Teen Sleep

Study Overview
=================
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.

Official Title
-----------------
Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep and Psychiatric Health in Adolescents

Conditions
-----------------
Sleep, Psychiatric Health

Intervention / Treatment
-----------------
* Behavioral: Garmin, Pattern Health App


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Digital Behavioral Intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SHEETS Arm 1<br>Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise. | Behavioral: Garmin, Pattern Health App<br>* Wearable sensors will deliver individualized feedback to participants according to their assigned intervention<br>|
| Experimental: SHEETS Arm 2<br>Participants will receive sleep education-related content to support good sleep, like setting schedules. | Behavioral: Garmin, Pattern Health App<br>* Wearable sensors will deliver individualized feedback to participants according to their assigned intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Regularity Index (SRI) | 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 | baseline, 6 weeks, 3 months, 6 months | 
| Feasibility as measured by Recruitment rate | The number of participants consenting (and assenting) divided by the number who were invited. | 6 months | 
| Feasibility as measured by Retention Rate | The number of participants who return for each sleep regularity assessment divided by the number who were eligible upon completion of the baseline assessment. | 6 months | 
| Acceptability as measured by activity completion | The number of participants who complete all weekly sessions divided by the total number of weekly sessions. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-Reported Sleep Health | 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. | baseline, 6 weeks, 3 months, 6 months | 
| Change in Adolescent Reported Psychiatric Health | 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. | baseline, 6 weeks, 3 months, 6 months | 
| Change in Parent Reported Psychiatric Health | 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. | baseline, 6 weeks, 3 months, 6 months | 
| Sleep Regularity Index (SRI) as measured by Garmin | 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 | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescents, Sleep, Psychiatric Health, Digital Intervention