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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH128440-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHEETS Arm 1 | Active Comparator | Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise. |
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| SHEETS Arm 2 | Experimental | Participants will receive sleep education-related content to support good sleep, like setting schedules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garmin, Pattern Health App | Behavioral | Wearable sensors will deliver individualized feedback to participants according to their assigned intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Regularity Index (SRI) | 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. | Baseline, 6 weeks, 3 months, 6 months |
| Feasibility as Measured by Recruitment Percentage | 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. | 6 months |
| 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 | Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Reported Sleep Health | 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. | Baseline, 6 weeks, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Lunsford-Avery, Ph.D. | Duke University | Principal Investigator |
| Naomi Duke, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Children's Primary Care North Durham | Durham | North Carolina | 27704 | United States |
All of the individual participant data collected during the trial (including data dictionaries) will be available for this study after deidentification.
Immediately following publication. No end date.
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.
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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 Focus Groups - Adolescents | The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study. |
| FG001 | Phase 1 Focus Groups - Parents/Guardians | The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study. |
| FG002 | Phase 1 Focus Groups - Pediatricians | The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study. |
| FG003 | SHEETS Arm 1 - Adolescents | Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise. Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention |
| FG004 | SHEETS Arm 2 - Adolescents | Participants will receive sleep education-related content to support good sleep, like setting schedules. Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
| |||||||||||||
| Phase 2 |
|
Only adolescents enrolled in Phase 2 (the randomized clinical trial) participated in baseline analysis. Phase 1 (Focus Groups) concluded prior to Phase 2 (the randomized clinical trial). Baseline data was not collected on Phase 1 Focus Groups participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | SHEETS Arm 1 - Adolescents | Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise. Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Sleep Regularity Index (SRI) | 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. | Phase 2 randomized trial participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 weeks, 3 months, 6 months |
|
Up to 1 week
Data not collected on Phase 1 Focus Groups participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 Focus Groups - Adolescents | The first phase was for participation in focus groups in which adolescents provided feedback to refine both digital interventions for Phase 2 of this study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort with Actigraph watch | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica R. Lunsford-Avery, Ph.D. | Duke University | (919) 681-0035 | jessica.r.avery@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2025 | Jan 28, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2023 | Jul 19, 2024 | ICF_000.pdf |
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Digital Behavioral Intervention
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Participants will be randomly assigned to one of two interventions, and will not be told which intervention they are assigned to.
| Change in Adolescent Reported Psychiatric Health - Internalizing |
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. |
| Baseline, 6 weeks, 3 months, 6 months |
| Change in Parent Reported Psychiatric Health - Internalizing | 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. | Baseline, 6 weeks, 3 months, 6 months |
| Sleep Regularity Index (SRI) as Measured by Garmin | 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. | 6 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| SHEETS Arm 2 - Adolescents |
Participants will receive sleep education-related content to support good sleep, like setting schedules. Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| SHEETS Arm 2 |
Participants will receive sleep education-related content to support good sleep, like setting schedules. Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention |
|
|
|
| Primary | Feasibility as Measured by Recruitment Percentage | 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. | All invited participants prior to randomization. | Posted | Number | percentage of participants | 6 months |
|
|
|
| Primary | Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment | Phase 2 randomized trial participants. | Posted | Count of Participants | Participants | 6 weeks, 3 months, 6 months |
|
|
|
| Primary | Acceptability as the Average Adherence Rate | Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100. | Phase 2 randomized trial participants who completed the study. | Posted | Mean | Standard Deviation | percentage of sessions completed | 6 weeks |
|
|
|
|
| Secondary | Change in Self-Reported Sleep Health | 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. | Phase 2 randomized trial participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 3 months, 6 months |
|
|
|
|
| Secondary | Change in Adolescent Reported Psychiatric Health - Internalizing | 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. | Phase 2 randomized trial participants who completed the study and had a sufficient number of items completed in order to score. | Posted | Mean | Standard Deviation | T-score | Baseline, 6 weeks, 3 months, 6 months |
|
|
|
|
| Secondary | Change in Parent Reported Psychiatric Health - Internalizing | 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. | Phase 2 randomized trial participants who completed the study and had a sufficient number of items completed in order to score. | Posted | Mean | Standard Deviation | T-score | Baseline, 6 weeks, 3 months, 6 months |
|
|
|
|
| Secondary | Sleep Regularity Index (SRI) as Measured by Garmin | 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. | Phase 2 randomized trial participants who completed the study and had sufficient Garmin data to calculate an SRI during the intervention phase. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | SHEETS Arm 1 - Adolescents | Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise. Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention | 0 | 27 | 0 | 27 | 2 | 27 |
| EG002 | SHEETS Arm 2 - Adolescents | Participants will receive sleep education-related content to support good sleep, like setting schedules. Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention | 0 | 27 | 0 | 27 | 0 | 27 |
| Possible allergic reaction to Garmin watch | Product Issues | Non-systematic Assessment |
|
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| 6 months |
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| 3 months |
|
| 6 months |
|
| 3 months |
|
| 6 months |
|
| 3 months |
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| 6 months |
|