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Cognitive Behaviour Therapy for Sleep Problems in Children With Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT04319640
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Sijia Gu, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Sleep disturbance is very common in children with autism spectrum disorder (ASD),and closely associated with their core symptom, social deficit.This trial investigates the effects of Cognitive behaviour therapy for insomnia (CBT-I) in children with autism spectrum disorder with sleep problems through synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS). This is a 1:1 parallel single-blind randomized controlled trial.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Cognitive Behaviour Therapy Behavioral: Cognitive behaviour therapy for insomnia Behavioral: psychoeducation for ASD Not Applicable

Detailed Description:
sleep disturbance is significantly associated with social deficit of ASD and but the congnitive-neural mechanism underlying this association remains unclear. Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia. After 5 consecutive sleep interventions is a 2-year following up study, the above issue is further tested with emphasis on progressive trajectory from a developmental perspective. we examine the influence of sleep disturbance on face processing and neural response during naturalistic social behavior of ASD children using synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social deficit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 parallel randomized controlled trial
Masking: Single (Participant)
Masking Description: Participant blind
Primary Purpose: Treatment
Official Title: the Effects of Sleep Intervention in Children With Autism Spectrum Disorder Through Synchronized Eye-tracking and Functional Near-infrared Spectroscopy
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBTI
N= 80 participants are offered Cognitive behaviour therapy for insomnia (CBT-I)
Behavioral: Cognitive behaviour therapy for insomnia
CBT-I for children with ASD includes sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. The treatment consists of 5 weekly modules.

Behavioral: psychoeducation for ASD
psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.

Active Comparator: psychoeducation
N= 80 participants are offered psychoeducation about information on ASD
Behavioral: psychoeducation for ASD
psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.




Primary Outcome Measures :
  1. congnitive-neural outcomes [ Time Frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds ]
    The investigators examine the influence of sleep disorders on face processing and neural response at baseline, 6 months after the intervention, 12 months after the intervention and when children 6 year olds by synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social-emotional development.

  2. ADOS-2 [ Time Frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds ]
    The ADOS-2 is the standard instrument for assessing autism spectrum disorders (ASD) across age, developmental level, and language skills.


Secondary Outcome Measures :
  1. Sleep diaries by using Actigraphy [ Time Frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds ]
    Different sleep parameters, such as sleep onset latency (SOL) and wake after sleep onset (WASO) will be determined using wrist actigraphy. Participants will be provided with an actiwatch at baseline, 6 months after the intervention , 12 months after the intervention and when children 6 year olds . The actiwatch will be worn on the non-dominant arm 24 hours a day, except for while bathing, during the 1-week screening periodmovement and nighttime sleep parameters.



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Ages Eligible for Study:   24 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. meet the diagnostic criteria for autism DSM-5 and ADOS-2;
  2. age 24months to 59months s old;
  3. willing to participate in this study, and can complete the following assessments at the specific time.

Exclusion Criteria:

Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;


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): NCT04319640


Contacts
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Contact: Fan Jiang, PhD 021-38626161 fanjiang@shsmu.edu.cn

Locations
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China, Shanghai
shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Guanghai Wang, PhD    021-38626161    wang-guanghai@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Fan Jiang, PhD Shanghai Children's Medical Center
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Responsible Party: Sijia Gu, staff of Research Department, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04319640    
Other Study ID Numbers: SCMCIRB-K2018040
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders