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Идёт набор NCT06240325

Sleep Promotion Program Primary Care

Без фазы С лечением Sleep Sleep Disturbance Insufficient Sleep

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SPP, Sleep Psychoeducation.
Кому может быть актуально
Состояния в реестре: Sleep, Sleep Disturbance, Insufficient Sleep. Базовые параметры: 12 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care

Обзор

Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on two individual sessions and smart phone technology to deliver evidence-based strategies. This R34 will test the feasibility and initial effectiveness of the SPP program and provider training via pilot randomized controlled trial (RCT, n=50) comparing SPP to Sleep Psychoeducation, a brief session on healthy sleep habits. Participants will be adolescents (12-18 years) with short sleep duration, sleep-wake irregularity, and depression.

Вмешательства

  • Поведенческое SPP
    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 t
  • Поведенческое Sleep 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.

Первичные конечные точки

  • Feasibility of Intervention Measure [Срок оценки: Post-Intervention (~8 weeks)]
  • Acceptability of Intervention Measure [Срок оценки: Post-Intervention (~8 weeks)]
  • Intervention Appropriateness Measure [Срок оценки: Post-Intervention (~8 weeks)]
  • Clinical Global Impressions Scale - Improvement [Срок оценки: Post-Intervention (~8 weeks)]
  • Patient Health Questionnaire - 9 - M [Срок оценки: Change Screening to Post-Intervention (~10 weeks)]
Вторичные конечные точки (6)
  • Pediatric Sleep Survey Sleep Knowledge (SK) [Срок оценки: Training Start to End of Study Involvement (Up to 2.5 years)]
  • SPP Therapy Rating Scale [Срок оценки: Completed at each SPP Session (2 and 4 weeks after baseline)]
  • Sleep Diary Sleep Duration [Срок оценки: Baseline to Post-Intervention (~8 weeks)]
  • Sleep Diary Sleep-Wake Regularity [Срок оценки: Baseline to Post-Intervention (~8 weeks)]
  • Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR) [Срок оценки: Baseline to Post-Intervention (~8 weeks)]
  • Pediatric Sleep Survey PC [Срок оценки: Training Start to End of Study Involvement (up to 2.5 years)]

Критерии участия

Критерии включения

Youth:

  • Able and willing to provide informed assent (with consent from parent/guardian)
  • Ages 12-18
  • Currently a patient at Kids Plus Pediatrics
  • Currently depressed
  • Report short sleep duration (<7 hours on school nights) and/or weekday-weekend sleep timing difference of >=2 hours

Parents:

Parents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week.

Критерии исключения

Youth:

  • Significant or unstable medical conditions
  • Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder
  • Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder
  • Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep
  • Changes in medications in the month prior to screening
  • Active suicidality requiring immediate treatment
  • Unable or unwilling to comply with study procedures
  • Have any physical or mental condition that would preclude study participation.

Parents will be excluded if they:

  • Express active suicidality that requires immediate treatment;
  • Have any physical or mental condition that would preclude study participation; OR
  • Are unable or unwilling to comply with study procedures.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06240325 · STUDY23010211 (RCT) · R34MH132724

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗