Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02755051
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2016-03-11
Brief Title:
Targeting Sleep in Kids With Autism Spectrum Disorder
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
Targeting Sleep in Kids With Autism Spectrum Disorder
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children with Autism Spectrum Disorder ASD and insomnia and their parents 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 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 parents 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 ADOS27 andor Autism Diagnostic Interview - Revised ADI-R28 The Thompson Center database currently includes 337 children with ASD ages 6-12 who have completed the ADOS andor ADIR and have IQ75 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 diaries30 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 childs 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 strategies5-7 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 Mazureks 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 repetitionpractice incorporation of special interests and video modeling
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 ADOS27 andor Autism Diagnostic Interview - Revised ADI-R28 The Thompson Center database currently includes 337 children with ASD ages 6-12 who have completed the ADOS andor ADIR and have IQ75 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 diaries30 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 childs 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 strategies5-7 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 Mazureks 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 repetitionpractice incorporation of special interests and video modeling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None