Targeting Sleep in Kids With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline Subjective Sleep at 18 weeks
研究概览
简要总结
Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 8 sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and ASD (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up.
Study Flow:
Baseline (wk1-2) ---> CBT-CI-A (wk3-10) ---> Post-Treatment (wk11-12) --->Wks 13-16 --->Follow-up (wk 17-18)
Session:
- Sleep education
- Sleep scheduling, limit setting, and stimulus control
- Teaching relaxation strategies and other adaptive coping skills
- Parenting strategies (differential attention, rewards, consequences)
- Identification of maladaptive & adaptive cognitions
- Problem solving & communication skills
- Sleep restriction; bright light to change circadian rhythms
- Review gains and plan for long-term maintenance
详细描述
Children with ASD and insomnia, and their parent(s) will undergo 8 sessions of CBT-CI-A. Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up.
Children (6-12 yrs; n = 30) who meet full DSM (Diagnostic and Statistical Manual) criteria18 for ASD and insomnia will be recruited from an existing clinical registry database. Eligibility criteria for initial recruitment will include IQ (intelligence quotient) of 75 or above (to ensure ability to participate in cognitive components of treatment), previous DSM diagnosis of ASD, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).28 The Thompson Center database currently includes 337 children with ASD ages 6-12 who have completed the ADOS and/or ADIR and have IQ>75. Following initial recruitment, eligibility for participation will include DSM diagnosis of insomnia. Insomnia will be diagnosed by study staff using gold standard diagnostic tools, a brief (10 min.) structured interview, Child Sleep Habits Questionnaire29, and sleep diaries.30 Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries. Dr. Sahota will provide referrals for children with suspected sleep apnea. Additional criteria will include participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level. Given previous experience, size of the database and insomnia prevalence in ASD, the investigators expect no difficulty recruiting our target sample size.
Treatment will be manualized and individually administered by graduate students trained by Drs. McCrae and Mazurek. Parent and child will be actively involved in treatment.
CBT-CI-A will use established behavioral sleep strategies.5-7 Treatment will be adapted from a manualized protocol developed and tested by Dr. McCrae in TD children. Adaptations for children with ASD will be based on Dr. Mazurek's experience and expertise, practice pathway recommendations of the ATN, and previously published CBT adaptations for treatment of anxiety in children with ASD. Adaptations will include increased use of visual supports, greater opportunities for repetition/practice, incorporation of special interests, and video modeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •previous Diagnostic and Statistical Manual of Mental Disorders diagnosis of Autism Spectrum Disorder, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).
- •Who have IQ>
- •Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries.
- •Participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level.
排除标准
- •unable to provide informed consent
- •unable to implement treatment due to sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI >15], Periodic Limb Movement Disorder (PLMD [myoclonus arousals per hour >15])
- •bipolar or seizure disorder (due to risk of sleep restriction treatment)
- •other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
研究组 & 干预措施
CBT-CI-A Therapy
Participants in this group receive Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder (CBT-CI-A)
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Change from Baseline Subjective Sleep at 18 weeks
时间窗: Daily 18 weeks from Baseline thru Follow-up
With parental assistance, all child participants will complete daily sleep diaries each morning
Change from Baseline Subjective Sleep at 12 weeks
时间窗: Daily for 12 weeks from Baseline thru Post-treatment
With parental assistance, all child participants will complete daily sleep diaries each morning
Change from Baseline Objective Sleep at 12 weeks
时间窗: Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Child participants will wear an actigraph all day for those weeks
Change from Baseline Objective Sleep at 18 weeks
时间窗: Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment and 2 weeks at Follow-up
Child participants will wear an actigraph during those weeks
次要结局
- Change in subjective Parent Sleep from Baseline at 12 weeks(Daily for 12 weeks from Baseline thru Post-treatment)
- Change in objective Parent Sleep from Baseline at 18 weeks(Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment, and 2 weeks at Follow-up)
- Child Behavior at Baseline(To be completed at 2 weeks)
- Child Behavior at Follow-up(To be completed at 18 weeks)
- Change in objective Parent Sleep from Baseline at 12 weeks(Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment)
- Child Behavior at Post-treatment(To be completed at 12 weeks)
- Change in subjective Parent Sleep from Baseline at 18 weeks(Daily for 18 weeks from Baseline thru Follow-up)
研究者
Christina McCrae
Principal Investigator
University of Missouri-Columbia