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

Shanghai Jiao Tong University School of Medicine

Status: Unknown

Conditions: Autism Spectrum Disorder; Cognitive Behaviour Therapy

Treatments: Behavioral: psychoeducation for ASD; Behavioral: Cognitive behaviour therapy for insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT04319640

SCMCIRB-K2018040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 24 to 59 months old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

CBTI

Experimental group

Description:

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

Treatment:

Behavioral: psychoeducation for ASD

Behavioral: Cognitive behaviour therapy for insomnia

psychoeducation

Active Comparator group

Description:

N= 80 participants are offered psychoeducation about information on ASD

Treatment:

Behavioral: psychoeducation for ASD