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Targeting Sleep in Kids With Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT02755051
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Christina McCrae, University of Missouri-Columbia

Brief 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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Chronic Insomnia Behavioral: Cognitive Behavioral Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Sleep in Kids With Autism Spectrum Disorder
Actual Study Start Date : July 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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:

  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
Other Name: CBT-CI-A




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755051


Locations
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United States, Missouri
Department of Health Psychology, University of Missouri-Columbia
Columbia, Missouri, United States, 65203
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Christina S McCrae, Ph. D University of Missouri-Columbia

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Responsible Party: Christina McCrae, Principal Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02755051    
Other Study ID Numbers: 2004675
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases