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

Primary Purpose

Autism Spectrum Disorder, Cognitive Behaviour Therapy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cognitive behaviour therapy for insomnia
psychoeducation for ASD
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

24 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • shanghai children's medicial center affiliated shanghai jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBTI

psychoeducation

Arm Description

N= 80 participants are offered Cognitive behaviour therapy for insomnia (CBT-I)

N= 80 participants are offered psychoeducation about information on ASD

Outcomes

Primary Outcome Measures

congnitive-neural outcomes
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.
ADOS-2
The ADOS-2 is the standard instrument for assessing autism spectrum disorders (ASD) across age, developmental level, and language skills.

Secondary Outcome Measures

Sleep diaries by using Actigraphy
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.

Full Information

First Posted
February 6, 2020
Last Updated
March 20, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04319640
Brief Title
Cognitive Behaviour Therapy for Sleep Problems in Children With Autism Spectrum Disorder
Official Title
the Effects of Sleep Intervention in Children With Autism Spectrum Disorder Through Synchronized Eye-tracking and Functional Near-infrared Spectroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Cognitive Behaviour Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 parallel randomized controlled trial
Masking
Participant
Masking Description
Participant blind
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBTI
Arm Type
Experimental
Arm Description
N= 80 participants are offered Cognitive behaviour therapy for insomnia (CBT-I)
Arm Title
psychoeducation
Arm Type
Active Comparator
Arm Description
N= 80 participants are offered psychoeducation about information on ASD
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behaviour therapy for insomnia
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
psychoeducation for ASD
Intervention Description
psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.
Primary Outcome Measure Information:
Title
congnitive-neural outcomes
Description
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.
Time Frame
changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
Title
ADOS-2
Description
The ADOS-2 is the standard instrument for assessing autism spectrum disorders (ASD) across age, developmental level, and language skills.
Time Frame
changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
Secondary Outcome Measure Information:
Title
Sleep diaries by using Actigraphy
Description
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.
Time Frame
changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: meet the diagnostic criteria for autism DSM-5 and ADOS-2; age 24months to 59months s old; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Jiang, PhD
Phone
021-38626161
Email
fanjiang@shsmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan Jiang, PhD
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghai Wang, PhD
Phone
021-38626161
Email
wang-guanghai@163.com

12. IPD Sharing Statement

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

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