Autism Spectrum DisorderNCT04319640
Cognitive Behaviour Therapy for Sleep Problems in Children With Autism Spectrum Disorder
A study testing Cognitive behaviour therapy for insomnia and psychoeducation for ASD in people with Autism Spectrum Disorder and Cognitive Behaviour Therapy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 59 months
- Conditions the study is for
- Autism Spectrum Disorder, Cognitive Behaviour Therapy
- What is being tested?
- Cognitive behaviour therapy for insomnia and psychoeducation for ASD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Guanghai Wang, PhD, 021-38626161, wang-guanghai@163.com
About this study
Official title: the Effects of Sleep Intervention in Children With Autism Spectrum Disorder Through Synchronized Eye-tracking and Functional Near-infrared Spectroscopy
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.
Read the detailed 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.
- Being tested
- Cognitive behaviour therapy for insomnia, psychoeducation for ASD
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behaviour therapy for insomniaBehavioural
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 ASDBehavioural
psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.
| Study group | Role | What they receive |
|---|---|---|
| CBTI | Experimental | N= 80 participants are offered Cognitive behaviour therapy for insomnia (CBT-I) Receives: Behavioral: Cognitive behaviour therapy for insomnia; Behavioral: psychoeducation for ASD |
| psychoeducation | Active comparator | N= 80 participants are offered psychoeducation about information on ASD Receives: Behavioral: psychoeducation for ASD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Mar 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sijia Gu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Fan Jiang, PhD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319640
- Sponsor's protocol ID
- SCMCIRB-K2018040
- Status last verified
- Mar 2020
- First submitted
- 6 Feb 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of Sleep Intervention in Children With Autism Spectrum Disorder Through Synchronized Eye-tracking and Functional Near-infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT04319640
- Acronym / sponsor ID
- SCMCIRB-K2018040
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1:1 parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| CBTI | Experimental | Behavioral: Cognitive behaviour therapy for insomnia, Behavioral: psychoeducation for ASDN= 80 participants are offered Cognitive behaviour therapy for insomnia (CBT-I) |
| psychoeducation | Active comparator | Behavioral: psychoeducation for ASDN= 80 participants are offered psychoeducation about information on ASD |
Who may qualify
- Ages
- 24 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behaviour therapy for insomniaCBT-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. | Behavioural | CBTI |
| psychoeducation for ASDpsychoeducation contains information about ASD, The treatment consists of 5 weekly modules. | Behavioural | CBTI, psychoeducation |
Primary outcome
congnitive-neural outcomes
Time frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
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.
ADOS-2
Time frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
The ADOS-2 is the standard instrument for assessing autism spectrum disorders (ASD) across age, developmental level, and language skills.
1 secondary outcome
Sleep diaries by using Actigraphy
Time frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fan Jiang, PhD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behaviour therapy for insomnia and psychoeducation for ASD in people with Autism Spectrum Disorder and Cognitive Behaviour Therapy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Jiang, PhD (021-38626161, fanjiang@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
congnitive-neural outcomes (time frame: changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.