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

NCT ID: NCT04319640

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-12-31

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.

Conditions

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Autism Spectrum Disorder Cognitive Behaviour Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 parallel randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant blind

Study Groups

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CBTI

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

Group Type EXPERIMENTAL

Cognitive behaviour therapy for insomnia

Intervention Type 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.

psychoeducation for ASD

Intervention Type BEHAVIORAL

psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.

psychoeducation

N= 80 participants are offered psychoeducation about information on ASD

Group Type ACTIVE_COMPARATOR

psychoeducation for ASD

Intervention Type BEHAVIORAL

psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.

Interventions

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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.

Intervention Type BEHAVIORAL

psychoeducation for ASD

psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

24 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sijia Gu

staff of Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fan Jiang, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Locations

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shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fan Jiang, PhD

Role: CONTACT

021-38626161

Facility Contacts

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Guanghai Wang, PhD

Role: primary

021-38626161

Other Identifiers

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SCMCIRB-K2018040

Identifier Type: -

Identifier Source: org_study_id

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