Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents with Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in sleep impairment by using The Insomnia Severity Index (ISI)
研究概览
简要总结
This trial investigates the behavioural effects of Internet-based Cognitive behaviour therapy for insomnia (CBT-I) in adolescents with autism spectrum disorder with sleep problems. This is a randomised controlled trial.
详细描述
Sleep problems are common in adolescents with autism spectrum disorder (ASD)1. Internet-based Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia 2. To date, no Internet-based CBT-I delivered treatment for sleep problems in adolescents with ASD has been undertaken. The objective of the study is to investigate the efficacy and effectiveness of the Internet-based CBT-I for sleep problems in adolescents with ASD.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents with a clinical ASD diagnosis based on the Diagnostic and Statistical Manual-fifth edition (DSM-5). Participants have been investigated with the Autism Diagnostic Observation Schedule (ADOS).
- •Insomnia diagnosis or sleep problems according to DSM-5
- •Intelligence quotient (IQ) > 70 according to Wechsler Intelligence Scale for Children - fourth edition
- •Psychiatric comorbidities according to DSM-5: anxiety disorders or depression.
排除标准
- •The presence of clinically assessed self-injury
- •High risk of suicidal behaviour
- •borderline personality disorder or any form of schizophrenia or related disorders;
- •substance abuse as well as physical illness or condition that was largely influence sleep condition.
结局指标
主要结局
Change in sleep impairment by using The Insomnia Severity Index (ISI)
时间窗: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
The ISI is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Participants rate the following components on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely): (a) severity of sleep-onset, sleep-maintenance, and early morning awakening problems; (b) satisfaction with current sleep pattern; (c) interference with daily functioning; (d) noticeability of impairment attributed to the sleep problem; and (e) level of distress caused by the sleep problem. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity.
次要结局
- Sleep diaries by using Actigraphy(Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up)
- Quality of sleep by using Athens Insomnia Scale (AIS)(Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up)
- Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16)(Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up)
- Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS)(Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up)
- Anxiety problems by using Spence Children's Anxiety Scale(Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up)
研究者
Nora Choque Olsson
PhD, Principal investigator
Stockholm University