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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033218
Receipt No. R000037826
Scientific Title The efficacy of group CBT for children with autism spectrum disorder to reduce anxiety symptoms.
Date of disclosure of the study information 2018/07/01
Last modified on 2021/01/31

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Basic information
Public title The efficacy of group CBT for children with autism spectrum disorder to reduce anxiety symptoms.
Acronym The efficacy of group CBT for children with autism spectrum disorder to reduce anxiety symptoms.
Scientific Title The efficacy of group CBT for children with autism spectrum disorder to reduce anxiety symptoms.
Scientific Title:Acronym The efficacy of group CBT for children with autism spectrum disorder to reduce anxiety symptoms.
Region
Japan

Condition
Condition autism spectrum disorder, anxiety disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 o examine effectiveness of group cognitive behavior therapy to reduce anxiety symptoms in children with autism spectrum disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes anxiety symptoms in children
Key secondary outcomes general psychopathology in chidren

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 group cognitive behavioral therapy
Interventions/Control_2 randomization
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria 1.intellectual function within average range (verbal IQ higher than 80, full scale IQ higher than 70)
2. diagnosis of autism spectrum disorders (by best practice or gold standard scales)
3. clinical level of anxiety symptoms (judged by semi-structured interview)
Key exclusion criteria 1. concurrent diagnosis of other severe psychiatric disease without ASD.

2. Patients will not be able to participate in sessions.

3.any other reason, researcher judged inappropriate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tomiki
Middle name
Last name Sumiyoshi
Organization National Center of Neurology and Psychiatry
Division name National Institute of Mental Health
Zip code 187-8553
Address 4-1-1 Ogawahigashi-cho, Kodaira city,Tokyo
TEL +81-42-341-2711
Email sumiyot@ncnp.go.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Oka
Organization National Center of Neurology and Psychiatry
Division name National Institute of Mental Health
Zip code 187-8553
Address 4-1-1 Ogawahigashi-cho, Kodaira city,Tokyo
TEL +81-42-341-2711
Homepage URL
Email okataku@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Nippon life Insurance Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Metropolitan Child Medical center, Manaboshi clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center of Neurology and Psychiatry
Address 4-1-1 Ogawahigashi-cho, Kodaira city,Tokyo
Tel 042-341-2712
Email rinri-jimu@ncnp.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京都立小児総合医療センター(東京都)、まな星クリニック(岡山県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 49
Results There was no significant difference in the anxiety symptoms of the children in the intervention group and the waiting group, but there was a significant improvement in the general psychiatric symptoms of the children in the intervention group compared to the waiting group.
Results date posted
2021 Year 01 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures Children's Anxiety Symptoms
Children's General Psychiatric Symptoms
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 05 Month 30 Day
Date of IRB
2018 Year 05 Month 16 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 30 Day
Last modified on
2021 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037826

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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