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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism Spectrum Disorder, Cognitive Behaviour Therapy

Intervention / Treatment
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* Behavioral: Cognitive behaviour therapy for insomnia
* Behavioral: psychoeducation for ASD


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 parallel randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBTI<br>N= 80 participants are offered Cognitive behaviour therapy for insomnia (CBT-I) | Behavioral: Cognitive behaviour therapy for insomnia<br>* 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.<br>Behavioral: psychoeducation for ASD<br>* psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.<br>|
| Active Comparator: psychoeducation<br>N= 80 participants are offered psychoeducation about information on ASD | Behavioral: psychoeducation for ASD<br>* psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.<br>|

What is the study measuring?
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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 |