Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Electronic Sleep Diaries - Child
研究概览
简要总结
The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child inclusion:
- •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.
- •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.
排除标准
- •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
研究组 & 干预措施
CBT-I
Immediate CBT-I for typically developing children using a 4-session digital intervention.
干预措施: CBT-I (Behavioral)
Waitlist Control
Participants in the waitlist control will have delayed treatment (4 weeks later).
干预措施: CBT-I (Behavioral)
结局指标
主要结局
Electronic Sleep Diaries - Child
时间窗: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Primary: child sleep onset latency (lights-out until sleep onset) and total sleep time. All other sleep diary variables are secondary (e.g., sleep efficiency (total sleep time/time in bed x 100%). Child (with caregiver assistance) and caregiver complete electronic diaries each morning (\~5 mins) during each 1-week assessment and throughout treatment.
Actigraphy - Child
时间窗: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
Primary variables: child sleep onset latency and total sleep time. All other actigraphy variables are secondary. Children wear actigraphs (Fitbit Inspire 3, Google), watch-like device, that monitors light and gross motor activity. Data analyzed using 30s epochs. Validated algorithm estimates SOL, TST, WASO, sleep efficiency and other variables provided by diaries. A combination of diary and actigraphy data estimates bed/waketime variability. Children wear devices 24/7 during each 1-week assessment.
Session Completion
时间窗: within 1 week post-treatment
Percentage of treatment sessions completed
Treatment Adherence
时间窗: within 1 week post-treatment
Percentage of instructions followed as indicated on treatment adherence logs
Internet Intervention Utility Questionnaire (IIUQ)
时间窗: within 1 week post-treatment
16-item measure designed to assess usability, likeability, usefulness, understandability, and convenience of an Internet intervention using a 5-point Likert scale, ranging from 0 (not at all) to 4 (very). Two additional open-ended questions ask about the most and least helpful aspects of the program. Scoring range is 0-64.
Treatment Satisfaction Survey
时间窗: within 1 week post-treatment
9-item measure designed to provide feedback on the study, including its structure, assessments, scheduling, working with study staff, and the usability of the intervention platforms using a 10-point Likert scale, ranging from 1 (strongly disagree) to 10 (strongly agree) and open-ended questions
Pediatric Insomnia Severity Index
时间窗: baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
The Pediatric Insomnia Severity Index is a six-item questionnaire that assesses insomnia symptom severity in children 4-10 years old. Items are rated on a 0-6 point scale based on the child's sleep over the past week. Scoring range is 0-30 with with higher scores indicating greater insomnia severity.
次要结局
- Child Sleep Habits Questionnaire-Abbreviated(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Pediatric Symptom Checklist-17(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2)(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Pediatric Daytime Sleepiness Scale(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Revised Children's Anxiety and Depression Scale-25(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Strengths and Difficulties Questionnaire(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Heart rate variability - Child(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Peds Quality of Life(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Heart rate variability - Caregiver(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Actigraphy - Caregiver(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Electronic Sleep Diaries - Caregiver(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- State-Trait Anxiety Inventory (STAI-Y1) - Caregiver(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Beck Depression Inventory -II - Caregiver(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Fatigue Severity Scale - Caregiver(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Daily Fatigue - Caregiver(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
- Caregiver Strain Index - Caregiver(baseline, within 1 week post treatment, 1 month follow up, 3 month follow up)
研究者
Christina McCrae
Professor
University of South Florida