ACTRN12620000374965尚未招募未知
Does the treatment of sleep problems in adolescents with ADHD improve outcomes? A randomised controlled trial.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 13 Years 至 16 Years(—)
- 性别
- All
入选标准
- •1. Adolescent has been previously diagnosed with ADHD and currently meets DSM-5 criteria for ADHD as assessed using the ADHD Rating Scale IV. During the screening interview parents will be administered the ADHD Rating Scale and asked to rate their adolescent's behaviour when not on stimulant medication. As per DSM 5 criteria, parents will need to endorse at least 6/9 Inattention and/or 6/9 Hyperactivity/impulsivity symptoms, symptom duration of at least 6 months, age of onset prior to 12 years, and evidence of impairment across settings.
- •2. Both parent AND adolescent report that the adolescent has a mild, moderate or severe sleep problem that fulfils criteria for chronic insomnia disorder and/or delayed sleep-wake phase disorder according to the American Academy of Sleep Medicine, International Classification of Sleep Disorders (3rd Edition).
- •Adolescent participants currently taking melatonin, as well as any other medications (SSRI’s etc.), will be included in the trial if they continue to meet the above eligibility criteria.
排除标准
- •1. Adolescents with a major medical condition (e.g., cerebral palsy, Fragile X disorder)
- •2. Adolescents with obstructive sleep apnoea.
- •3. Adolescents with an intellectual disability.
- •4. Adolescents with current suicidality, psychosis or mania
- •5. Adolescents who are currently receiving psychosocial treatment for their sleep difficulties.
- •6. Non-English speaking families.
研究者
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