Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr

Обзор

The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.

Подробное описание

This is a pilot study to examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children aged 6-12 with insomnia and their caregiver(s) compared to a waitlist control.

Вмешательства

• Поведенческое CBT-I
  Cognitive behavioral therapy for insomnia

Первичные конечные точки

• Electronic Sleep Diaries - Child [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Actigraphy - Child [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Session Completion [Срок оценки: within 1 week post-treatment]
• Treatment Adherence [Срок оценки: within 1 week post-treatment]
• Internet Intervention Utility Questionnaire (IIUQ) [Срок оценки: within 1 week post-treatment]
• Treatment Satisfaction Survey [Срок оценки: within 1 week post-treatment]
• Pediatric Insomnia Severity Index [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]

Вторичные конечные точки (12)

• Child Sleep Habits Questionnaire-Abbreviated [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Pediatric Symptom Checklist-17 [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2) [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Pediatric Daytime Sleepiness Scale [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Revised Children's Anxiety and Depression Scale-25 [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Strengths and Difficulties Questionnaire [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Heart rate variability - Child [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Peds Quality of Life [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Heart rate variability - Caregiver [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Actigraphy - Caregiver [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• Electronic Sleep Diaries - Caregiver [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]
• State-Trait Anxiety Inventory (STAI-Y1) - Caregiver [Срок оценки: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up]

Критерии участия

Критерии включения

Child inclusion:

• 6-12 yrs
• Verbal IQ > 70 (to ensure verbal skills are sufficient to participate in treatment)
• participation of child's parent or legal guardian living in the same home
• child diagnosed with insomnia, 5) willing to accept random assignment.

Insomnia:

1\) insomnia complaints for 3+ months by child report or caregiver observation that consist of (a) difficulties falling asleep, staying asleep, and/or waking up too early, (b) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, and (c) Pediatric Insomnia Severity Index score >8

Caregiver inclusion:

• ability to read and understand English at the 5th grade level
• willing to accept random assignment.

Критерии исключения

Child exclusion:

• child unable to provide informed consent or child unable to provide assent
• child unwilling to accept random assignment
• child participation in another randomized research project
• child unable to complete forms or implement treatment procedures due to cognitive impairment
• child untreated medical comorbidity including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
• child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin as described in #7 (see Notes below for details)
• child stimulants, sleep medications (prescribed or OTC), and/or melatonin within the last 1 month (unless stabilized on medication for 3+ months)
• child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
• child other conditions adversely affecting trial participation.

Caregiver exclusion criteria:

• unable to provide informed consent
• unwilling to accept random assignment
• caregiver participation in another randomized research project
• unable to complete forms or implement treatment procedures due to cognitive impairment
• caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of South Florida — Tampa

Публикации

• McCrae CS, Stearns MA, Mazurek MO, Page J, Holland B, Takagishi J, Emmanual P, Zhang X, Kapolka M, Craggs C, Gonzalez D, Owens J. Digital Cognitive Behavioral Treatment of Insomnia in Youth: Protocol for an RCT Examining Feasibility, Acceptability, and Efficacy of LAMBI. Behav Sleep Med. 2026 May 28:1-15. doi: 10.1080/15402002.2026.2667840. Online ahead of print. PMID 42210669

Идентификаторы

NCT: NCT07091149 · STUDY006258

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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