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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBTI | Experimental | N= 80 participants are offered Cognitive behaviour therapy for insomnia (CBT-I) |
|
| psychoeducation | Active Comparator | N= 80 participants are offered psychoeducation about information on ASD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behaviour therapy for insomnia | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Jiang, PhD | Contact | 021-38626161 | fanjiang@shsmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fan Jiang, PhD | Shanghai Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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1:1 parallel randomized controlled trial
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Participant blind
| psychoeducation for ASD | Behavioral | psychoeducation contains information about ASD, The treatment consists of 5 weekly modules. |
|
| changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds |