Transdiagnostic Sleep and Circadian Treatment for Autistic Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Multidimensional sleep health (MSH) score
研究概览
简要总结
Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt and optimize an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adults, who are at increased risk for mental health disorders, using a transdiagnostic approach. The knowledge gained from this study will help to address a critical need for accessible transdiagnostic sleep interventions for autistic adults, who experience a broad range of sleep and circadian problems at high rates and often lack access to specialty care treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autistic adults diagnosed with ASD.
- •Between the ages of 18 and 65 years.
- •English-speaking
- •One or more sleep or circadian problem(s) for a period of at least 3 months assessed with the Sleep and Circadian Problems Interview.
排除标准
- •A history of IQ <
- •A history of psychotic, bipolar or seizure disorders as per medical record.
- •Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome, as per structured interview based on risk screeners.
研究组 & 干预措施
Transdiagnostic Sleep and Circadian Intervention
干预措施: Transdiagnostic Intervention for Sleep and Circadian Dysfunction (Behavioral)
结局指标
主要结局
Multidimensional sleep health (MSH) score
时间窗: baseline (pretreatment)
Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.
Multidimensional sleep health (MSH) score
时间窗: posttreatment (up to 6 weeks post baseline)
Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.
次要结局
- Participants retention rate (feasibility)(from enrollment to session 6 (up to 6 months))
- Enrollment rate (feasibility)(up to 6 months)
- Therapist Evaluation Questionnaire (TEQ) Total Score at End of Treatment(posttreament (up to 3 months from baseline))
- Therapy Homework Completion Rate(from first session to posttreament (up to 3 months from baseline))
- Treatment Session Completion Rate(from first session to posttreament (up to 3 months from baseline))
- Treatment Fidelity: Therapist Strategy Use(from first session to posttreament (up to 3 months from baseline))
研究者
Kristina Lenker
Assistant Professor of Psychiatry and Behavioral Health
Milton S. Hershey Medical Center