Deakin University, Geelong, Victoria, Australia
Deakin University, Geelong, Victoria, Australia.
BMJ Open. 2019 Nov 19;9(11):e029767. doi: 10.1136/bmjopen-2019-029767.
Sleep problems are a characteristic feature of children with autism spectrum disorder (ASD) with 40% to 80% of children experiencing sleep difficulties. Sleep problems have been found to have a pervasive impact on a child's socio-emotional functioning, as well as on parents' psychological functioning. The project aims to evaluate the efficacy of a brief behavioural sleep intervention in reducing ASD children's sleep problems in a fully powered randomised controlled trial (RCT). Intervention impact on child and family functioning is also assessed.
The RCT aims to recruit 234 children with a diagnosis of ASD, aged 5-13 years, who experience moderate to severe sleep problems. Participants are recruited from paediatrician clinics in Victoria, Australia, and via social media. Families interested in the study are screened for eligibility via phone, and then asked to complete a baseline survey online, assessing child sleep problems, and child and family functioning. Participants are then randomised to the intervention group or treatment as usual comparator group. Families in the intervention group attend two face-to-face sessions and a follow-up phone call with a trained clinician, where families are provided with individually tailored behavioural sleep strategies to help manage the child's sleep problems. Teacher reports of sleep, behavioural and social functioning are collected, and cognitive ability assessed to provide measures blind to treatment group. The primary outcome is children's sleep problems as measured by the Children's Sleep Habits Questionnaire at 3 months post-randomisation. Secondary outcomes include parent and child quality of life; child social, emotional, behavioural and cognitive functioning; and parenting stress and parent mental health. Cost-effectiveness of the intervention is also evaluated.
Findings from this study will be published in peer-reviewed journals and disseminated at national and international conferences, local networks and online.
ISRCTN14077107 (ISRCTN registry dated on 3 March 2017).
睡眠问题是自闭症谱系障碍（ASD）儿童的一个特征，40%至 80%的儿童存在睡眠困难。研究发现，睡眠问题对儿童的社会情感功能以及父母的心理功能都有广泛的影响。本项目旨在评估一项简短行为睡眠干预在全功率随机对照试验（RCT）中减少 ASD 儿童睡眠问题的疗效。还评估了干预对儿童和家庭功能的影响。
RCT 旨在招募 234 名被诊断为 ASD、年龄在 5-13 岁、有中度至重度睡眠问题的儿童。参与者从澳大利亚维多利亚州的儿科诊所和社交媒体招募。对有兴趣参与研究的家庭进行电话筛选，然后要求他们在线完成基线调查，评估儿童的睡眠问题以及儿童和家庭功能。然后将参与者随机分配到干预组或常规治疗对照组。干预组的家庭参加两次面对面会议和一次与训练有素的临床医生的随访电话，在电话中，为家庭提供个性化的行为睡眠策略，以帮助管理儿童的睡眠问题。收集教师报告的睡眠、行为和社会功能，并评估认知能力，以提供对治疗组盲目的措施。主要结局是儿童在随机分组后 3 个月时通过儿童睡眠习惯问卷测量的睡眠问题。次要结局包括父母和儿童的生活质量；儿童的社会、情感、行为和认知功能；以及育儿压力和父母的心理健康。还评估了干预的成本效益。
本研究的结果将发表在同行评议的期刊上，并在全国和国际会议、当地网络和在线上传播。
ISRCTN81034455（ISRCTN 注册表日期为 2017 年 3 月 3 日）。
