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.
研究组 & 干预措施
Intervention group
Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks
干预措施: Good Night Project (Behavioral)
Control group - usual care
Participants in the control group will receive usual care. They will also attend their usual appointments with the psychiatrists. They will not receive any intervention.
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