Pilot RCT to Compare a Home Based Tailored Cognitive Behavioral Therapy for Insomnia (CBT-I) Versus Webased CBT-I to Improve Sleep in Caregivers With Insomnia in the Context of Caring for a Child With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Feasibility of pilot study
研究概览
简要总结
Autism Spectrum Disorder (ASD) represents one of the most perplexing neurobiological disorders with a prevalence of 1 in 54 children. The lifelong challenging and disruptive behaviors often associated with ASD requires caregivers to change their behavior and modify their environments to provide an ecosystem for optimal outcomes for their child, family and themselves. ASD behaviors can have significant impact on caregivers mental health and family functioning, including the ability to develop and maintain healthy sleep routines. The caregiving population in US has a high prevalence of insomnia; two thirds of caregivers experiencing difficulties falling and/or staying asleep. The prevalence of insomnia in children with ASD is equally high, 60-80% experiencing night waking contributing to poor daytime behavior and disrupted sleep in the caregivers. This pilot RCT will focus on improving caregivers sleep in the context of caring for a child with ASD and insomnia with a multi-disciplinary team. The investigators will compare a home-based tailored CBT for Insomnia (CBT-I) versus a web-based Way to Health CBT-I intervention. This data will support a larger RCT with the Department of Defense funding opportunity through the Congressionally Directed Medical Research Program. This Autism Research Program focuses on improving lives of those living with ASD.
详细描述
Overall objectives
The investigators propose to compare a home-based tailored CBT-I intervention versus a web-based Way to Health (WTH) platform tailored CBT-I intervention for caregivers with insomnia in the context of caring for a child with ASD and insomnia. This pilot RCT will further the investigators previous work and investigate the feasibility, acceptability, and efficacy of a web based versus home-based CBT-I intervention for both the caregiver with insomnia and the child with ASD and insomnia. The investigators also hope to gain a greater understanding of the relationships between child and caregiver sleep, caregiver psychiatric conditions, child behavior, and maternal self-efficacy. These findings will provide preliminary data for a larger RCT to improve sleep for all family members. The specific aims of this pilot study are:
- To determine the acceptability and feasibility of a RCT design utilizing a novel, web-based WTH platform versus a home- based CBT-I intervention to improve sleep of a caregiver with insomnia and a child with ASD and insomnia. The investigators plan to evaluate the recruitment, retention, randomization, and training required for this study.
- To examine the relationship between caregiver self- efficacy, caregiver psychiatric conditions and sleep, and child daytime behaviors and sleep pre and post intervention.
- To compare the effect of a home- based tailored CBT-I versus web based WTH CBT-I on child and caregiver sleep with a primary endpoint of total sleep time and sleep latency measured with Actigraphy, caregiver mental health scores, and child daytime behaviors.
Primary outcome variable(s)
- To determine the acceptability and feasibility of a RCT design with the Opinion Survey assessing acceptability with an 8 items rated on a 7- point Likert scale survey This study will be considered feasible if we obtain a 70% completion rate for the repeated measures. Acceptability of the web-based and home based will be determined by parent acceptability survey. This protocol will be considered acceptable to parents if the acceptability score is 70% or greater.
- To compare the effect of a home- based tailored CBT-I versus web based WTH CBT-I on child and caregiver sleep with a primary endpoint of total sleep time and sleep latency measured with Actigraphy Secondary outcome variable(s) To examine the relationship between caregiver self- efficacy, caregiver psychiatric conditions, child daytime behaviors and sleep parameters pre and post intervention. To examine the mediation effect of caregiver self-efficacy on the relationship between depressive symptoms, caregiver and child sleep, and child symptom severity and behavior, the investigators will use the Baron and Kenny 4-step regression model.71 Independent predictors of depressive symptoms will be tested and adjusted in all analytical steps. Mediation analysis will be performed for all subjects in a pooled sample, followed by a sensitivity analysis to determine the moderating role of child's symptom severity. Conduct a Sobel test to analyze the statistical significance of the mediation effect.
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
- None
入排标准
- 年龄范围
- 3 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Caregiver with a child with ASD:
- •Caregiver age 18 years or older
- •Diagnosis of Insomnia
- •Parental/guardian will give permission (informed consent) for child
- •Telephone and web Access
- •Stable medical and behavioral conditions, with no change in health status in the past three months
- •Commitment to maintaining stable medication doses and keeping medication consistent
- •Inclusion Criteria for Children with ASD:
- •Children age 3 to 17 years and one of their parents
- •Diagnosis of Autism Spectrum Disorders, confirmed with Autism Diagnostic Observation Schedule and/or DSM-IV criteria.
- •Diagnosis of Behavioral Insomnia or Insomnia due to ASD (Insomnia due to internal
- •Parental/guardian permission (informed consent) and if appropriate, child assent.
- •Telephone and web Access
- •Stable medical and behavioral conditions, with no change in health status in the past
- •Commitment to maintaining stable medication doses and keeping child's sleep medication consistent
排除标准
- •for Caregiver and child with ASD:
- •Insomnia due to co-occurring medical conditions and/ or sleep disorders such as obstructive sleep apnea (OSA), narcolepsy, restless leg syndrome, severe reflux, nocturnal asthma
- •Unstable co-occurring medical conditions such as epilepsy or other neurological disorders, sickle cell anemia, diabetes or severe eczema
- •Significant hearing or vision loss
- •Known genetic disorders such as Fragile X, 22ql 1.2 Deletion Syndrome, Rett Disorder, Down Syndrome.
- •Subjects who, in the opinion of the Investigator, may be non¬ compliant with study schedules or procedures.
研究组 & 干预措施
Home-based
home- based CBT-Insomnia intervention
干预措施: Cognitive behavioral therapy for Insomnia (Behavioral)
web-based
web-based CBT-Insomnia intervention
干预措施: Cognitive behavioral therapy for Insomnia (Behavioral)
结局指标
主要结局
Feasibility of pilot study
时间窗: At week 8
This study will be considered feasible if we obtain a 70% completion rate for the all measures.
Caregiver Acceptability Opinion Survey
时间窗: At week 8
Opinion Survey with 8 items rated on a 7- point Likert scale. minimum of 0 and max of 56 with a score of 40 or greater will be considered acceptable for this study.
次要结局
- Change in reported sleep on sleep diaries(8 weeks)
- Change in Child Daytime behaviors(week 8)
- Change in wake after sleep onset as measured by actigraphy for child(week 8)
- Change in total sleep time average measured by an actigraphy watch for caregiver(week 8)
- Change in sleep latency as measured by actigraphy watch for child(week 8)
- Change in Caregiver behaviors(week 8)
- Change in sleep latency as measured by actigraphy watch for caregiver(week 8)
- Change in wake after sleep onset as measured by by actigraphy watch for caregiver(week 8)
- Change in Maternal Self-efficacy(week 8)
- Change in total sleep time as measured by actigraphy watch for child(week 8)