Psychiatry, University of Missouri, Columbia, MO, USA
School of Education and Human Development, University of Virginia, Charlottesville, VA, USA.
BMJ Open. 2021 Aug 25;11(8):e045944. doi: 10.1136/bmjopen-2020-045944.
Insomnia affects up to 80% of children with autism spectrum disorder (ASD). Negative consequences of insomnia in ASD include decreased quality of life (QOL), impaired learning and cognition, increased stereotypic and challenging behaviours, and increased parental stress. Cognitive behavioural treatment for childhood insomnia (CBT-CI) is a promising treatment for dealing with insomnia and its negative consequences but has not yet been studied in school-aged children with ASD and comorbid insomnia. Access to healthcare is another challenge for children with ASD, particularly in rural and underserved regions. Previous studies indicate that ASD and insomnia share common arousal-based underpinnings, and we hypothesise that CBT-CI will reduce the hyperarousal associated with insomnia and ASD. This trial will be the first to examine CBT-CI adapted for children with ASD and will provide new information about two different modes of delivery across a variety of primary and secondary child and parent sleep and related outcomes. Knowledge obtained from this trial might allow us to develop new or modify current treatments to better target childhood insomnia and ASD.
Children (N=180) 6-12 years of age with ASD and insomnia will be recruited from an established autism database, a paediatric clinic and community outreach in the Columbia, MO and surrounding areas. Participants will be randomised to CBT-CI adapted for children with ASD (in-person or remote using computers with cameras) or Sleep Hygiene and Related Education. Participants will be assessed at baseline, post-treatment, 6-month and 12-month follow-ups. The following assessments will be completed regarding the children: objective and subjective sleep, daytime functioning (adaptive functioning, attention, challenging behaviours, anxiety), QOL and physiological arousal (heart rate variability) and parents: objective and subjective sleep, daytime functioning (anxiety, depression, fatigue), QOL, physiological arousal and parental burden/stress.
Ethics approval was obtained in January 2020 from the University of Missouri. Ethics approval was obtained in July 2020 from the US Army Medical Research and Development Command, Office of Research Protections and Human Research Protection Office. All data are expected to be collected by 2024. Full trial results are planned to be published by 2025. Secondary analyses of baseline data will be subsequently published.
NCT04545606; Pre-results.
失眠影响了多达 80%的自闭症谱系障碍（ASD）儿童。失眠在 ASD 中的负面影响包括生活质量（QOL）下降、学习和认知受损、刻板和挑战性行为增加以及父母压力增加。认知行为疗法治疗儿童失眠（CBT-CI）是一种治疗失眠及其负面影响的有前途的治疗方法，但尚未在患有 ASD 合并失眠的学龄儿童中进行研究。获得医疗保健也是 ASD 儿童面临的另一个挑战，特别是在农村和服务不足的地区。先前的研究表明，ASD 和失眠具有共同的基于唤醒的基础，我们假设 CBT-CI 将减少与失眠和 ASD 相关的过度唤醒。这项试验将是第一个针对 ASD 儿童进行的 CBT-CI 适应性试验，将提供关于儿童和父母睡眠及相关结果的各种主要和次要的两种不同传递模式的新信息。从这项试验中获得的知识可能使我们能够开发新的或修改现有的治疗方法，以更好地针对儿童失眠和 ASD。
将从密苏里哥伦比亚市的一个已建立的自闭症数据库、儿科诊所和社区外展中招募 6-12 岁患有 ASD 和失眠的儿童（N=180）。参与者将被随机分配到针对 ASD 儿童的 CBT-CI（面对面或远程使用带摄像头的计算机）或睡眠卫生和相关教育。参与者将在基线、治疗后、6 个月和 12 个月随访时进行评估。将对儿童完成以下评估：客观和主观睡眠、白天功能（适应功能、注意力、挑战性行为、焦虑）、生活质量和生理唤醒（心率变异性）以及父母：客观和主观睡眠、白天功能（焦虑、抑郁、疲劳）、生活质量、生理唤醒和父母负担/压力。
该研究于 2020 年 1 月获得密苏里大学的伦理批准。该研究于 2020 年 7 月获得美国陆军医学研究与发展司令部、研究保护办公室和人类研究保护办公室的伦理批准。预计所有数据将于 2024 年收集完毕。计划于 2025 年发表完整的试验结果。随后将发表基线数据的二次分析。
NCT04545606；预结果。
