ACTRN12619001360101终止未知
Assessing the effect of melatonin on sleep behaviour and executive functioning in children with Fetal Alcohol Spectrum Disorder
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 9
研究概览
简要总结
Data being processed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 5 Years 至 12 Years（—）
- 性别
- All
入选标准
- •Children aged between 5- and 12-years with confirmed prenatal alcohol exposure and who have been assessed using the Australian Guidelines for the diagnosis of FASD to have either FASD with 3 Sentinel Facial Features (SFF); FASD with < 3 SFF or At Risk” of FASD (Bower & Elliott, 2016), and with reported sleep problems (see Inclusion Criteria).
- •Sleep Problem Inclusion Criteria
- •Children will be included in the study if their parents/caregivers report that they have problems with sleep initiation, whereby sleep onset latency is equal to or greater than 30 minutes, three nights or more a week, for equal to or more than three months.
排除标准
- •1) Are not currently receiving sedative medications,
- •2) Who have changed place of residence or primary carers in the last three months (as this instability may be contributing to sleep problems independent from FASD).
- •3) Have been diagnosed with Type 1 diabetes.
研究者
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