Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Conners' Parent Rating Scale-48 (CPRS-48)
研究概览
简要总结
The study aims to implement and evaluate an RCT of behavioural sleep interventions for children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to address the following questions:
- To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD?
- To what extent do intervention-induced changes in sleep for children or primary caregivers (women) account for any changes in ADHD symptoms?
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 (Investigator)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants will be primary caregivers (women) of children aged 5-12 years who have been diagnosed with ADHD by a psychiatrist, using the criteria taken from Diagnostic and Statistical Manual of Mental Disorders-5 in Saudi Arabia.
- •Children with comorbidities will be also included.
- •Sleep difficulties are defined as a total score of over 41 in the Children's Sleep Habits Questionnaire (CSHQ).
排除标准
- •Children will be excluded from the study if they meet any of the following criteria:
- •They receive non-pharmacological interventions for their sleep difficulties.
- •They have been previously diagnosed as having an intellectual disability (IQ < 70).
- •They have obstructive sleep apnoea, according to the three items in the CSHQ.
结局指标
主要结局
Conners' Parent Rating Scale-48 (CPRS-48)
时间窗: 2 months
This scale consists of 48 items that focus on five subscales: conduct problems, learning disabilities, psychosomatic disorders, impulsivity and hyperactivity and anxiety. It focuses on children aged 3-17 years.
The Children's Sleep Habits Questionnaire CSHQ
时间窗: 2 months
This is used widely to assess sleep, pre and post intervention, and focuses on measurement of the following subscales: Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnias, sleep-disordered breathing and daytime sleepiness. Higher scores indicate significant sleep difficulties.
次要结局
- Conners' Teachers Rating Scale-28 (CTRS-28)(1 month)
- The Sleep Disorders Scale for primary caregivers(2 months)
- The Depression Anxiety Stress Scales DASS(2 months)
研究者
Hetaf Alammar
PhD student
University of Leeds