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OpenTrials
Completed

NCT Number: NCT02755051

Targeting Sleep in Kids With Autism Spectrum Disorder

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

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health Psychology, University of Missouri-Columbia

Columbia, Missouri, 65203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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>75.
  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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 names: CBT-CI-A

Primary outcomes

  1. Change from Baseline Subjective Sleep at 12 weeks

    Time frame: Daily for 12 weeks from Baseline thru Post-treatment

    With parental assistance, all child participants will complete daily sleep diaries each morning

  2. Change from Baseline Objective Sleep at 12 weeks

    Time frame: Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment

    Child participants will wear an actigraph all day for those weeks

  3. Change from Baseline Subjective Sleep at 18 weeks

    Time frame: Daily 18 weeks from Baseline thru Follow-up

    With parental assistance, all child participants will complete daily sleep diaries each morning

  4. Change from Baseline Objective Sleep at 18 weeks

    Time frame: 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

Secondary outcomes

  1. Child Behavior at Baseline

    Time frame: To be completed at 2 weeks

    The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors

  2. Child Behavior at Post-treatment

    Time frame: To be completed at 12 weeks

    The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors

  3. Child Behavior at Follow-up

    Time frame: To be completed at 18 weeks

    The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors

  4. Change in subjective Parent Sleep from Baseline at 12 weeks

    Time frame: Daily for 12 weeks from Baseline thru Post-treatment

    Parents will complete daily sleep diaries each morning

  5. Change in subjective Parent Sleep from Baseline at 18 weeks

    Time frame: Daily for 18 weeks from Baseline thru Follow-up

    Parents will complete daily sleep diaries each morning

  6. Change in objective Parent Sleep from Baseline at 12 weeks

    Time frame: Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment

    Parents will wear an actigraph during those weeks

  7. Change in objective Parent Sleep from Baseline at 18 weeks

    Time frame: Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment, and 2 weeks at Follow-up

    Parents will wear an actigraph during those weeks

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2016
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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