Sustainable Habits for Encouraging Even Teen Sleep

NCT05378373 | Completed

• 2 other identifiers: Pro001090131R34MH128440-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Psychiatric Health

Keywords

Adolescents; Sleep; Psychiatric Health; Digital Intervention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in Self-Reported Sleep Health

  baseline, 6 weeks, 3 months, 6 months

• Change in Adolescent Reported Psychiatric Health

  baseline, 6 weeks, 3 months, 6 months

• Change in Parent Reported Psychiatric Health

  baseline, 6 weeks, 3 months, 6 months

• Sleep Regularity Index (SRI) as measured by Garmin

  6 weeks

Study Arms (2)

SHEETS Arm 1

ACTIVE COMPARATOR

Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.

Behavioral: Garmin, Pattern Health App

SHEETS Arm 2

EXPERIMENTAL

Participants will receive sleep education-related content to support good sleep, like setting schedules.

Behavioral: Garmin, Pattern Health App

Interventions

Garmin, Pattern Health App BEHAVIORAL

Wearable sensors will deliver individualized feedback to participants according to their assigned intervention

SHEETS Arm 1; SHEETS Arm 2

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke Children's Primary Care North Durham

Durham, North Carolina, 27704, United States

Location

Study Officials

• Jessica Lunsford-Avery, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• Naomi Duke, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned to one of two interventions, and will not be told which intervention they are assigned to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Digital Behavioral Intervention

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: October 21, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 4, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)