NCT04319640

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

February 6, 2020

Last Update Submit

March 20, 2020

Conditions

Autism Spectrum DisorderCognitive Behaviour Therapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Sleep diaries by using Actigraphy

    changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds

Study Arms (2)

CBTI

EXPERIMENTAL

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

Behavioral: Cognitive behaviour therapy for insomniaBehavioral: psychoeducation for ASD

psychoeducation

ACTIVE COMPARATOR

N= 80 participants are offered psychoeducation about information on ASD

Behavioral: psychoeducation for ASD

Interventions

Cognitive behaviour therapy for insomniaBEHAVIORAL

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.

CBTI
psychoeducation for ASDBEHAVIORAL

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

CBTIpsychoeducation

Eligibility Criteria

Age24 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fan Jiang, PhD

    Shanghai Children's Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Jiang, PhD

CONTACT

021-38626161fanjiang@shsmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 parallel randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
staff of Research Department

Study Record Dates

First Submitted

February 6, 2020

First Posted

March 24, 2020

Study Start

March 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 31, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

CN(1)