UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033218 |
|---|---|
| Receipt number | 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 | 2023/01/24 00:01:27 |
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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
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
okataku@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037826
