Targeting Sleep in Kids With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      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:

        1. Sleep education

        2. Sleep scheduling, limit setting, and stimulus control

        3. Teaching relaxation strategies and other adaptive coping skills

        4. Parenting strategies (differential attention, rewards, consequences)

        5. Identification of maladaptive & adaptive cognitions

        6. Problem solving & communication skills

        7. Sleep restriction; bright light to change circadian rhythms

        8. Review gains and plan for long-term maintenance
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder involves 8, one-hour sessions of a non-drug cognitive behavioral intervention. Session content listed below:
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
Other intervention name(s): CBT-CI-A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment