Treatment of Sleep Disturbances in School-age Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)
研究概览
简要总结
The investigators long-term goal is to improve outcomes for children with Down syndrome (DS) and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will cater to the unique needs of children with DS, adapting an intervention that successfully treats behavioral sleep disturbances in children with autism1. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood.
详细描述
The investigators long-term goal is to improve outcomes for children with DS and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will catered to the unique needs of children with DS, adapting an intervention developed by a member of the investigators research team with NIH support (R34 MH082882) that successfully treats behavioral sleep disturbances in children with autism41. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood. As a critical first step towards an effective treatment, this initial efficacy study will address 3 aims:
Aim #1: Test the efficacy of manualized BST for improving the sleep of children with DS.
Hypothesis 1: Sleep duration and quality will improve more in the BST condition than the CON condition.
Aim #2: Test the impact of the BST on the daytime functioning of children with DS.
Hypothesis 2: Children receiving BST will make greater gains in inhibitory control, general behavior problems and other measures of executive dysfunction than in the CON condition.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of Down Syndrome
- •6-17 years of age
- •behavioral sleep problem (presence of 5 or more nights a week of: bedtime resistance, delayed sleep onset, problematic sleep associations, nighttime awakenings or morning awakenings)
- •English as primary language
排除标准
- •past diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified/Autism Spectrum Disorder
- •History of blindness,deafness,motor impairment
- •nonverbal mental age below 36 months
- •any medication change w/in past 2 months affecting sleep
研究组 & 干预措施
SMART
Treatment group targeting behavioral sleep problems for 5 weeks.
- Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems
- Information on healthy sleep hygiene, preventative techniques, and use of visual supports
- Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking
- Information on procedures for delayed sleep onset and problematic sleep associations
- Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future
干预措施: Behavioral Sleep Treatment (Behavioral)
WISE
Standard of care sleep treatment enhanced with psychoeducation. 1 Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome 2 Introduction to understanding and interpreting results from clinical evaluations 3 Introduction to educational planning, expectations, and transition planning 4 Introduction to lifespan development and advocacy and support services available 5 Feedback on current concerns and methods for obtaining services to manage concerns
干预措施: Standard of care sleep treatment enhanced with psychoeducation (Behavioral)
结局指标
主要结局
Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)
时间窗: Baseline, 6 Weeks, 19 Weeks
33-item Parent reported sleep quality for Child over past week. Each item is scored 1-3 (1 = Rarely, 0-1x/week; 2 = Sometimes, 2-4x/week; 3= Usually, 5-7x/week). There are 6 questions with reverse scoring. This will yield a total between 33 and 99. This will be acquired from parent three times throughout study, data scored and entered into SPSS by coordinator using total score data for comparatives to actigraph results for total sleep.
次要结局
- Improved child behaviors as measured by parent report on Child Behavior Checklist (CBCL)(Baseline, 6 Weeks, 19 Weeks)
- Longer Parent sleep duration as measured by actigraphy and reduced parental stress as measured by the Family Impact Questionnaire (FIQ).(Baseline, 6 Weeks, 19 Weeks)