Effects of Digitally Delivered Parent-based Behavioural Sleep Intervention in Children With Autism Spectrum Disorder (ASD) - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Child: Change of child's sleep problems
研究概览
简要总结
The goal of this randomised controlled trial is to examine the following research questions: 1) whether digitally delivered parent-based behavioural sleep intervention with or without personalised support is effective in improving sleep, clinical and daytime symptoms, and 2) whether such interventions can also improve parental sleep, mental health, and parenting stress in children with ASD and insomnia.
详细描述
A randomised, assessor-blind, parallel-group controlled trial (RCT) will be conducted in children with ASD and insomnia. Eligible participants will be randomised to one of the following groups: app-based cognitive behavioural therapy for insomnia (CBT-I) with personalised support, app-based CBT-I without personalised support, or treatment-as-usual (TAU). Randomisation will be carried out using an automated online system and stratified by gender. Assessments will be conducted at pre-treatment and post-treatment (1 week after intervention completion). The two active treatment groups will be additionally followed up at post-treatment 3 months and posttreatment 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •(1) Parents/caregivers with a child aged 6 to 12 years old, and attending a local mainstream primary school at the time of recruitment;
- •(2) The child is diagnosed to have ASD, which will be based on the assessment conducted by a psychiatrist or a clinical psychologist that incorporates the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) assessment criteria, with corroboration by the Autism Diagnostic Interview - Revised (ADI-R);
- •(3) The child is reported by the parent/caregiver to have insomnia symptoms, typically a difficulty in falling asleep with or without bedtime resistance, which is operationally defined as sleep onset latency exceeding 25 minutes and occurring three or more times per week. The child's sleep problems have lasted for a minimum of three months and have led to an impairment in the daily functioning of the child and/or parents. Such inclusion criteria are based on the DSM-V criteria for insomnia, with the choice of a 25-minute sleep onset latency criteria based on the normative values reported by Scholle et al.;
- •(4) Parent owns and knows how to use smartphones and can comprehend Chinese language;
- •(5) The child's parent or guardian gives written informed consent of participation into the study;
- •(6) Being able to comply with the study protocol.
排除标准
- •(1) Children with diagnosed intellectual disability;
- •(2) Children with any diagnosed co-morbid neurological or medical conditions which could have affected their sleep, such as blindness, traumatic brain injury, epilepsy and poorly controlled eczema;
- •(3) Children with diagnosed sleep disorders other than insomnia or with suspected sleep apnoea (as assessed by the Children's Sleep Habits Questionnaire (CSHQ): obtaining a score of 4 or above on the sleep-disordered breathing subscale on the CSHQ) that may potentially contribute to a disruption in sleep continuity and quality. Children who are currently receiving regular melatonin treatment, as well as other medications such as Selective Serotonin Reuptake Inhibitors (SSRIs), will be considered for inclusion in the trial if they continue to meet the eligibility criteria.
研究组 & 干预措施
App-based CBT-I with personalised telephone support
App-based cognitive behavioural therapy for insomnia with personalised telephone support
干预措施: App-based CBT-I with personalised telephone support (Behavioral)
App-based CBT-I without personalised support
App-based cognitive behavioural therapy for insomnia without personalised telephone support
干预措施: App-based CBT-I without personalised telephone support (Behavioral)
TAU group
Participants will continue their usual clinical follow-up and receive standard treatment where needed. No app-based intervention and telephone support will be provided to this group.
结局指标
主要结局
Child: Change of child's sleep problems
时间窗: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
The Children's Sleep Habits Questionnaire (CSHQ) - parent report is a commonly used measure to assess sleep symptoms in children aged 4-12 years. It consists of 33 items to evaluate a child's sleep behavior over the past week. Items are rated on a 3-point scale to indicate the frequency of each sleep behavior: "usually/five to seven times per week," "sometimes/two to four times per week," and "rarely/zero to once per week." The CSHQ total score is the sum of the 33 questions and ranges from 33 to 99. Higher scores indicate more severe sleep disturbances.
次要结局
- Child: Change of child's ASD symptoms(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Child: Change of child's emotional and behavioural problems(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Child: Change of child's executive function(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Child: Change of child's daytime sleepiness(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Child: Change of child's quality of life(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Child: Change of parent-reported child sleep diary measures(Baseline, Post-Treatment (1 week after intervention completion) for all consented participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Child: Change of child's actigraphy-based measures(Baseline, Post-Treatment (1 week after intervention completion) for all consented participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for these participants in the treatment groups.)
- Child: Change of overall severity of child's clinical symptoms(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Parent: Change of parental insomnia symptoms(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Parent: Change of parental sleep quality(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Parent: Change of parental mental health(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Parent: Change of parenting stress(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Parent: Change of parental quailty of life(Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Parent: Change of parental sleep diary measures(Baseline, Post-Treatment (1 week after intervention completion) for all consented participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Parent: Change of parental actigraphy-based measures(Baseline, Post-Treatment (1 week after intervention completion) for all consented participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
研究者
Dr. Shirley Xin Li
Associate Professor
The University of Hong Kong