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

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Chronic Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Department of Health Psychology, University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CBT-CI-A Therapy; Participants in this group receive Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder (CBT-CI-A)

Behavioral: Cognitive Behavioral Therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Subjective Sleep at 12 weeks	With parental assistance, all child participants will complete daily sleep diaries each morning	Daily for 12 weeks from Baseline thru Post-treatment
Change from Baseline Objective Sleep at 12 weeks	Child participants will wear an actigraph all day for those weeks	Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Change from Baseline Subjective Sleep at 18 weeks	With parental assistance, all child participants will complete daily sleep diaries each morning	Daily 18 weeks from Baseline thru Follow-up
Change from Baseline Objective Sleep at 18 weeks	Child participants will wear an actigraph during those weeks	Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment and 2 weeks at Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Behavior at Baseline	The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors	To be completed at 2 weeks
Child Behavior at Post-treatment	The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors	To be completed at 12 weeks
Child Behavior at Follow-up	The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors	To be completed at 18 weeks
Change in subjective Parent Sleep from Baseline at 12 weeks	Parents will complete daily sleep diaries each morning	Daily for 12 weeks from Baseline thru Post-treatment
Change in subjective Parent Sleep from Baseline at 18 weeks	Parents will complete daily sleep diaries each morning	Daily for 18 weeks from Baseline thru Follow-up
Change in objective Parent Sleep from Baseline at 12 weeks	Parents will wear an actigraph during those weeks	Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Change in objective Parent Sleep from Baseline at 18 weeks	Parents will wear an actigraph during those weeks	Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment, and 2 weeks at Follow-up

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Christina S McCrae, Ph. D, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurodevelopmental Disorders; Sleep Initiation and Maintenance Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 2004675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO