Clinical trial NCT05378373: Sustainable Habits for Encouraging Even Teen Sleep
Official title: Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep and Psychiatric Health in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Psychiatric Health
Keywords: Adolescents
Sleep
Psychiatric Health
Digital Intervention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-05-18
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Digital Behavioral Intervention
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Sleep Regularity Index (SRI)
timeFrame: baseline, 6 weeks, 3 months, 6 months
measure: Feasibility as measured by Recruitment rate
timeFrame: 6 months
measure: Feasibility as measured by Retention Rate
timeFrame: 6 months
measure: Acceptability as measured by activity completion
timeFrame: 6 months
Secondary outcomes:
measure: Change in Self-Reported Sleep Health
timeFrame: baseline, 6 weeks, 3 months, 6 months
measure: Change in Adolescent Reported Psychiatric Health
timeFrame: baseline, 6 weeks, 3 months, 6 months
measure: Change in Parent Reported Psychiatric Health
timeFrame: baseline, 6 weeks, 3 months, 6 months
measure: Sleep Regularity Index (SRI) as measured by Garmin
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Children's Primary Care North Durham
state: North Carolina
Study officials:
affiliation: Duke University
name: Jessica Lunsford-Avery, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Naomi Duke, M.D.
role: PRINCIPAL_INVESTIGATOR
References: