Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-22 @ 1:06 PM
Study NCT ID:
NCT02755051
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting Sleep in Kids With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-04-25', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Subjective Sleep at 12 weeks', 'timeFrame': 'Daily for 12 weeks from Baseline thru Post-treatment', 'description': 'With parental assistance, all child participants will complete daily sleep diaries each morning'}, {'measure': 'Change from Baseline Objective Sleep at 12 weeks', 'timeFrame': 'Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment', 'description': 'Child participants will wear an actigraph all day for those weeks'}, {'measure': 'Change from Baseline Subjective Sleep at 18 weeks', 'timeFrame': 'Daily 18 weeks from Baseline thru Follow-up', 'description': 'With parental assistance, all child participants will complete daily sleep diaries each morning'}, {'measure': 'Change from Baseline Objective Sleep at 18 weeks', 'timeFrame': 'Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment and 2 weeks at Follow-up', 'description': 'Child participants will wear an actigraph during those weeks'}], 'secondaryOutcomes': [{'measure': 'Child Behavior at Baseline', 'timeFrame': 'To be completed at 2 weeks', 'description': 'The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors'}, {'measure': 'Child Behavior at Post-treatment', 'timeFrame': 'To be completed at 12 weeks', 'description': 'The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors'}, {'measure': 'Child Behavior at Follow-up', 'timeFrame': 'To be completed at 18 weeks', 'description': 'The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors'}, {'measure': 'Change in subjective Parent Sleep from Baseline at 12 weeks', 'timeFrame': 'Daily for 12 weeks from Baseline thru Post-treatment', 'description': 'Parents will complete daily sleep diaries each morning'}, {'measure': 'Change in subjective Parent Sleep from Baseline at 18 weeks', 'timeFrame': 'Daily for 18 weeks from Baseline thru Follow-up', 'description': 'Parents will complete daily sleep diaries each morning'}, {'measure': 'Change in objective Parent Sleep from Baseline at 12 weeks', 'timeFrame': 'Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment', 'description': 'Parents will wear an actigraph during those weeks'}, {'measure': 'Change in objective Parent Sleep from Baseline at 18 weeks', 'timeFrame': 'Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment, and 2 weeks at Follow-up', 'description': 'Parents will wear an actigraph during those weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder', 'Chronic Insomnia']}, 'descriptionModule': {'briefSummary': '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.\n\nStudy Flow:\n\nBaseline (wk1-2) ---\\> CBT-CI-A (wk3-10) ---\\> Post-Treatment (wk11-12) ---\\>Wks 13-16 ---\\>Follow-up (wk 17-18)\n\nSession:\n\n1. Sleep education\n2. Sleep scheduling, limit setting, and stimulus control\n3. Teaching relaxation strategies and other adaptive coping skills\n4. Parenting strategies (differential attention, rewards, consequences)\n5. Identification of maladaptive \\& adaptive cognitions\n6. Problem solving \\& communication skills\n7. Sleep restriction; bright light to change circadian rhythms\n8. Review gains and plan for long-term maintenance', 'detailedDescription': "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.\n\nChildren (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.\n\nTreatment will be manualized and individually administered by graduate students trained by Drs. McCrae and Mazurek. Parent and child will be actively involved in treatment.\n\nCBT-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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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).\n* Who have IQ\\>75.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* unable to provide informed consent\n* 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\\])\n* bipolar or seizure disorder (due to risk of sleep restriction treatment)\n* other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)"}, 'identificationModule': {'nctId': 'NCT02755051', 'briefTitle': 'Targeting Sleep in Kids With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Targeting Sleep in Kids With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '2004675'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-CI-A Therapy', 'description': 'Participants in this group receive Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder (CBT-CI-A)', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT-CI-A'], 'description': '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:\n\n1. Sleep education\n2. Sleep scheduling, limit setting, and stimulus control\n3. Teaching relaxation strategies and other adaptive coping skills\n4. Parenting strategies (differential attention, rewards, consequences)\n5. Identification of maladaptive \\& adaptive cognitions\n6. Problem solving \\& communication skills\n7. Sleep restriction; bright light to change circadian rhythms\n8. Review gains and plan for long-term maintenance', 'armGroupLabels': ['CBT-CI-A Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Department of Health Psychology, University of Missouri-Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Christina S McCrae, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christina McCrae', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}