Psychiatric Health, Sleep
Conditions
Keywords
Adolescents, Sleep, Psychiatric Health, Digital Intervention
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.
Interventions
BEHAVIORALGarmin, Pattern Health App
Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
Sponsors
Duke University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will be randomly assigned to one of two interventions, and will not be told which intervention they are assigned to.
Intervention model description
Digital Behavioral Intervention
Eligibility
Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity. |
| Feasibility as Measured by Recruitment Percentage | 6 months | The number of participants consenting (and assenting) divided by the number who were invited (i.e., passed the telephone prescreen) x 100 to produce a percentage. |
| Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment | 6 weeks, 3 months, 6 months | — |
| Acceptability as the Average Adherence Rate | 6 weeks | Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Sleep Health | Baseline, 6 weeks, 3 months, 6 months | Self-reported sleep will be assessed via the PROMIS pediatric sleep disturbances survey, an 8 item survey (each item is on a 5-point Likert scale ranging from Never to Always). The total score ranges from 0 to 32, where lower scores indicate better outcomes. |
| Change in Adolescent Reported Psychiatric Health - Internalizing | 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. The internalizing subscale is based on 31 items. The standardized T-score has a population mean of 50 with a standard deviation of 10. Lower scores indicate better outcomes. |
| Change in Parent Reported Psychiatric Health - Internalizing | 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. The internalizing subscale is based on 31 items. The standardized T-score has a population mean of 50 with a standard deviation of 10. Lower scores indicate better outcomes. |
| Sleep Regularity Index (SRI) as Measured by Garmin | 6 weeks | A measure of sleep regularity collected continuously over 7 days via Garmin. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Lunsford-Avery, Ph.D.
Duke University
PRINCIPAL_INVESTIGATORNaomi Duke, M.D.
Duke University
Participant flow
Recruitment details
Recruitment occurred during well-check visits in pediatric primary care clinics, via digital fliers through schools and social media, and by contacting parents or guardians of potentially eligible adolescents using contact information in the electronic health record (EHR).
Pre-assignment details
There are two phases to the study, and adolescent participants could participate in one or both phases. The first phase was for participation in focus groups in which adolescents, parents, and pediatricians provided feedback to refine both digital interventions for Phase 2 of this study. Phase 2 was the randomized controlled trial in which only adolescents were enrolled, and they completed one of two digital interventions.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 13.35 years STANDARD_DEVIATION 0.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 54 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 0 | 2 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 0 | 0 / 27 | 0 / 27 |
Outcome results
None listed