Sustainable Habits for Encouraging Even Teen Sleep (SHEETS)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Psychiatric Health
• Intervention / Treatment: Behavioral: Garmin, Pattern Health App

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke Children's Primary Care North Durham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jessica Lunsford-Avery, Ph.D., Duke University; Principal Investigator: Naomi Duke, M.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Sleep; Digital Intervention; Psychiatric Health
• Other Study ID Numbers: Pro00109013; 1R34MH128440-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial (including data dictionaries) will be available for this study after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Data will be accessible by researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals and questions for data access should be directed to NDAHelp@mail.nih.gov. To gain access, data requestors will need to sign a data access agreement at https://nda.nih.gov/nda/access-data-info.html.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No