Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Child Sleep Habits Questionnaire
研究概览
简要总结
The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate sleep onset latency and/or bedtime resistance difficulties. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime resistance).
详细描述
The purpose of the Family Help Sleep Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 80 children (6-12 years of age)suffering from mild to moderate sleep onset latency and/or bedtime resistance will be randomized.
The intervention is delivered from a distance, using an educational handbook and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children 5-12 years of age
- •attending grades primary-6 (Elementary School)
- •sleep onset latency and/or bedtime resistance
- •speak and write English
- •provides parental authorization
- •has access to telephone in home
排除标准
- •any mental health disease with the exclusion of disruptive behavior disorder
- •neurological conditions
- •moderate to severe cognitive impairment
- •has received a behavioral intervention for sleep difficulties in the past 6 months
- •nocturnal enuresis
- •sleep apnea
- •co-sleeping
结局指标
主要结局
Child Sleep Habits Questionnaire
时间窗: baseline, 2months (end of treatment) & 6 month follow-up
次要结局
- Child Behaviour Checklist (CBCL)(baseline, 2months (end of treatment) & 6 month follow-up)
- Satisfaction scale (researcher developed)(end of treatment)
- Parenting Stress Index(baseline, 2months (end of treatment) & 6 month follow-up)
- Actigraph recordings(daily during treatment; baseline, 2 & 6 months follow-up)
- Sleep diary(daily during treatment; on follow-up at 2 & 6 MONTHS post randomization)
- Child Health Questionnaire(baseline, 2months (end of treatment) & 6 month follow-up)