ACTRN12618001446257进行中（未招募）未知
Testing the use of an app intervention to improve behavioural sleep problems in children.
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participant (caregiver is the participant) must meet the following criteria to be enrolled in this study:
- •Participant (caregiver) is aged 18 years or older and the primary caregiver of a child referred to the Royal Children's Hospital (RCH) Sleep Clinic or self-referred from the community to study based on the child having behavioural sleep problems
- •Participant is capable of understanding an informed consent document and giving consent
- •Be a caregiver of a child is aged from 24 months, up to and including 13 years* with one or more behavioural sleep problem(s) as assessed by the American Academy of Sleep Medicine diagnostic criteria:
- •o sleep onset association disorder
- •o limit setting disorder
- •o delayed sleep phase
- •o primary insomnia
- •o anxiety-related insomnia
- •o night terrors, nightmares
- •o sleep walking/talking and rhythmic movement disorders;
- •The participant (caregivers) must also rate their child's sleep problem as moderate/severe according to the item below;
- •Over the last 2 weeks, how much of problem has your child’s sleep been? Response options are none, mild, moderate, or severe.
排除标准
- •Participants (caregivers) meeting any of the following criteria will be excluded from the study:
- •Known history of caregiver intellectual disability or neurological disorder
- •Identified to have insufficient English to complete the intervention and study questionnaire
- •Their child if the child has a major illness or disability (such as cerebral palsy, cancer, etc.).
- •Parents who rate their child's sleep problem as no/mild problem
- •Children who have a diagnosis of attention deficit hyperactivity disorder (ADHD) or autism may be included in the study depending on severity and the impairment associated with their condition. Cases where the child is non-verbal or has a known IQ less than 70 (many children with ASD/autism will have had IQ testing for as part of service provision) will be excluded from the study. Unclear cases will be referred to Dr Harriet Hiscock (Paediatrician and study P.I.; see next point). An IQ below 70 indicates intellectual disability, which is likely to interfere in the effectiveness of the intervention. While the App is used by the parent, the intervention is unsuitable for children with developmental delays as the intervention is based on the parent communicating new boundaries and instructions to the child based on their chronological age.
- •Where researchers are unclear regarding patient eligibility, their case will be referred to Dr Harriet Hiscock (Paediatrician and study P.I.) for review, based on information provided by the caregiver about the child’s functioning and communication.
- •Participants who do not have access to a mobile phone or device that can run the App (both Apple and Android devices are compatible with the App).
- •Their child’s sleep condition child is suspected to have a non-behavioural sleep problem, such as obstructive sleep apnoea (OSA). The likelihood of the sleep problem being an OSA will be established during the two phases of screening (see screening procedures in 5.3.3). OSA will either be advised by the referring clinician (Screening A) or by the caregiver during the screening call (Screening B). During the parent screening call, three items of the Child’s Sleep Habits Questionnaire will be asked to identify the existence of potential OSA.
研究者
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