A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Actigraphy (Total Sleep Time)
研究概览
简要总结
The objective of this K01 study was to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize sleep health in adolescents 10-18 years of age with neurodevelopmental disorders (NDDs).
详细描述
The investigators conducted a sequential, multiple assignment, randomized trial (SMART) pilot feasibility study to inform implementation of a future full-scale SMART design that will be used to construct adaptive biobehavioral sleep intervention strategies involving melatonin, a behavioral sleep intervention (The Bedtime Bank), and their combination for the management of sleep disturbance in adolescents with neurodevelopmental (NDDs). Participants completed 1 week of baseline data collection, and than were randomly assigned to either melatonin or The Bedtime Bank. Response (>/= 18 minute average nightly increase in total sleep time [TST]) was measured at Week 4 and Week 8. Participants who responded (>/= 18 minute average nightly increase in TST) at Week 4 remained on the assigned intervention. Participants who were non-responsive at Week 4 were re-randomized to a different sleep intervention or combined interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10-18 years and consistently living with parental (or legal guardian) supervision.
- •Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).
- •Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ>70).
- •Parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the Children's Sleep Habits Questionnaire.
- •Medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medication (unless provider directed) during study participation.
排除标准
- •Unwillingness to stop melatonin 2 months prior to enrollment in the study.
- •Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).
- •Adolescents who are not able to take oral medication.
- •Adolescents who are visually impaired with known inability to detect light.
- •Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).
- •Unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial.
研究组 & 干预措施
Melatonin than Bedtime Bank
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 2, non-responders to melatonin will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
干预措施: Melatonin (Dietary Supplement)
Bedtime Bank than Bedtime Bank+Melatonin Combo
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 2, non-responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
干预措施: Melatonin (Dietary Supplement)
The Bedtime Bank Only
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 2, responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks).
干预措施: Bedtime Bank (Behavioral)
Melatonin than Bedtime Bank
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 2, non-responders to melatonin will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
干预措施: Bedtime Bank (Behavioral)
Melatonin than Melatonin+Bedtime Bank Combo
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 2, non-responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
干预措施: Bedtime Bank (Behavioral)
Bedtime Bank than Melatonin
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 2, non-responders to The Bedtime Bank will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
干预措施: Bedtime Bank (Behavioral)
Melatonin Only
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 2, responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks).
干预措施: Melatonin (Dietary Supplement)
Bedtime Bank than Bedtime Bank+Melatonin Combo
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 2, non-responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
干预措施: Bedtime Bank (Behavioral)
Bedtime Bank than Melatonin
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 2, non-responders to The Bedtime Bank will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
干预措施: Melatonin (Dietary Supplement)
Melatonin than Melatonin+Bedtime Bank Combo
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 2, non-responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Actigraphy (Total Sleep Time)
时间窗: To be worn daily for the entirety of the study (9 weeks total). Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)
Objective measure of sleep patterns based on the correlation between sleep-wake state and motor activity. A sleep diary was utilized to guide data analysis.
AARP- Abbreviated Acceptability Rating Profile
时间窗: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)
Parents completed the Abbreviated Acceptability Rating Profile (AARP), which will be used to indicate minimal treatment acceptability. Parent(s) and adolescent completed a semi-structured interview to discuss treatment acceptability. Min/Max Values: 8-48 Higher scores=more acceptable/better
次要结局
- Urinary Melatonin(Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.)
- PROMIS Pediatric Item Bank Sleep Disturbance(Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.)
- Cleveland Adolescent Sleepiness Questionnaire (CASQ)(Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8))
- PROMIS Pediatric Item Bank Sleep Related Impairment(Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.)