Sleep Promotion Program Primary Care

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• Parasomnias 755
• Sleep Deprivation 298

Study arms

• Experimental
  Sleep Promotion Program

  Participants will receive the Sleep Promotion Program (SPP), consisting of 2 individual sessions with a clinician via telehealth (or in-person if desired), about 2 weeks apart, and web-based intervention components.

  Behavioral: SPP

• Active comparator
  Sleep Psychoeducation

  Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person).

  Behavioral: Sleep Psychoeducation

Interventions

• BehavioralSPP

  SPP prioritizes increasing sleep duration and regularizing sleep-wake timing. The provider and youth review the youth's sleep pattern, based on sleep diary data collected before and during the program and actigraphy data collected at baseline. They discuss benefits to the current sleep pattern, reasons for changing sleep, and they create an action plan. Psychoeducation about healthy sleep is offered via a handout developed by our group. Youth and provider jointly select SPP strategies relevant to the contributors to poor sleep for each youth (e.g., time management, limiting weekend oversleep). In the second session they review progress and adjust the plan. Parents participate for part of each session to learn about their child's sleep and to discuss ways they can support their child to make the planned changes.

• BehavioralSleep Psychoeducation

  Using the pamphlet also used in SPP, SPE will present sleep hygiene practices commonly included in sleep education programs and endorsed by national health organizations.

Primary outcomes

1. Feasibility of Intervention Measure

   The Feasibility of Intervention Measure (FIM) is a 4-item measure that assesses the feasibility of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.

   Time frame: Post-Intervention (~8 weeks)

2. Acceptability of Intervention Measure

   The Acceptability of Intervention Measure (AIM) is a 4-item measure that assesses the acceptability of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.

   Time frame: Post-Intervention (~8 weeks)

3. Intervention Appropriateness Measure

   The Intervention Appropriateness Measure (IAM) is a 4-item measure that assesses the appropriateness of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5.

   Time frame: Post-Intervention (~8 weeks)

4. Clinical Global Impressions Scale - Improvement

   This is a clinician rating of improvement in sleep and psychopathology. Clinicians rate domains of sleep health, psychiatric symptoms, and overall health on a range from 1 very much improved) to 7 (very much worse). A score of 0 indicates no assessment. Scores for each domain are reported individually.

   Time frame: Post-Intervention (~8 weeks)

5. Patient Health Questionnaire - 9 - M

   This is a self-report measure of depressive symptoms. It consists of 9 items rated 0 (not at all) to 3 (nearly every day) over the past 2 weeks. Scores on those 9 items are summed to create a total score (0-27, higher score indicates greater depression).

   Time frame: Change Screening to Post-Intervention (~10 weeks)

Secondary outcomes

1. Pediatric Sleep Survey Sleep Knowledge (SK)

   This is a provider self-report of knowledge about sleep. The sleep knowledge domain has 21 items that assess provider knowledge or sleep. The response options are true, false, or don't know. The number or percentage of correctly scored items is reported.

   Time frame: Training Start to End of Study Involvement (Up to 2.5 years)

2. SPP Therapy Rating Scale

   This is a form completed by an independent rater who will review session recordings and rate them for fidelity. The scale has 5 items rated no (0) or yes (1), and 24 items rated 0 (not discussed/delivered) to 3 (excellent use of the skill). Items can be reported individually or can be summed to obtain a total score. Scale score range is 0 to 77

   Time frame: Completed at each SPP Session (2 and 4 weeks after baseline)

3. Sleep Diary Sleep Duration

   This is a youth daily self-report of sleep, from which will be extracted sleep duration, reported in hours and minutes.

   Time frame: Baseline to Post-Intervention (~8 weeks)

4. Sleep Diary Sleep-Wake Regularity

   This is a youth daily self-report of sleep, from which will be extracted sleep regularity, reported as difference in sleep-wake timing between weekdays and weekends.

   Time frame: Baseline to Post-Intervention (~8 weeks)

5. Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR)

   This is a secondary measure of youth depression, completed by self-report, with 17 items rated on a 0 to 3 likert scale. The total score is made by summing some of the items with a total score range of 0-27.

   Time frame: Baseline to Post-Intervention (~8 weeks)

6. Pediatric Sleep Survey PC

   This is a provider self-report of their comfort and capacity delivering the SPP intervention. The comfort and capacity domain asks about provider comfort delivering 14 behavioral sleep strategies, with responses on a likert scale from not at all comfortable to very comfortable. Responses can be reported individually, as well as a percentage of strategies that providers stated they were somewhat or very comfortable providing.

   Time frame: Training Start to End of Study Involvement (up to 2.5 years)

Individual participant data

Plan to share: Yes — In accordance with the National Institute of Mental Health (NIMH) Data Archive Data Use Certification, investigators will share data collected as part of this proposal with outside investigators. To access data from this study, outside investigators will be asked to submit a proposal that incudes project aims and hypotheses, variables and analytic approach, and rationale for the proposed analysis. The proposal would also include information on how and where the data will be used, investigators' qualifications, timeframe in which data will be analyzed/submitted/published, source of financial support, and conflict of interest statement. They will be asked to sign a data sharing agreement and confidentiality statement prior to the sharing of this data.

Supporting information: Study protocol, Sap, Icf