UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011156 |
|---|---|
| Receipt number | R000013062 |
| Scientific Title | A preliminary study of cognitive behavior therapy for children with autism spectrum disorder and anxiety |
| Date of disclosure of the study information | 2013/07/09 |
| Last modified on | 2013/07/09 12:02:21 |
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Basic information
Public title
A preliminary study of cognitive behavior therapy for children with autism spectrum disorder and anxiety
Acronym
Cognitive behavior therapy for children with autism and anxiety
Scientific Title
A preliminary study of cognitive behavior therapy for children with autism spectrum disorder and anxiety
Scientific Title:Acronym
Cognitive behavior therapy for children with autism and anxiety
Region
| Japan |
Condition
Condition
autism spectrum disorders, anxiety disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness of group cognitive behavior therapy to reduce anxiety symptoms in children with autism spectrum disorders, and determine the predictors of its effectiveness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
anxiety sympsoms in children
Key secondary outcomes
general psychopathology in chidren
stress responsiveness in children
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
group cognitive behavior therapy
Interventions/Control_2
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
| 7 | years-old | <= |
Age-upper limit
| 12 | 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 depression or psychosis
2. Parents will not be able to participate in more than 80% of sessions, or have difficulty in partipating in group activity for some reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Kamio |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health, Department of Child and Adolescent Mental Health
Zip code
Address
4-1-1 Ogawahigashi-cho,
TEL
+81-42-346-1978
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health, Department of Child and Adolescent Mental Health
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
独立行政法人 国立精神・神経医療研究センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 09 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2013 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 09 | Day |
Last modified on
| 2013 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013062
