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

the Effects of Sleep Intervention in Children With Autism Spectrum Disorder Through Synchronized Eye-tracking and Functional Near-infrared Spectroscopy

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder; Cognitive Behaviour Therapy
• Intervention / Treatment: Behavioral: Cognitive behaviour therapy for insomnia; Behavioral: psychoeducation for ASD

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fan Jiang, PhD; Phone Number: 021-38626161; Email: fanjiang@shsmu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
      • Contact: Guanghai Wang, PhD; Phone Number: 021-38626161; Email: wang-guanghai@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Fan Jiang, PhD, Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: SCMCIRB-K2018040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No