UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050187 |
|---|---|
| Receipt number | R000056981 |
| Scientific Title | Development of intensive psychoeducation program for tic disorders using internet |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/31 13:49:20 |
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Basic information
Public title
Development of intensive psychoeducation program for tic disorders using internet
Acronym
Development of psychoeducation program for tic disorders.
Scientific Title
Development of intensive psychoeducation program for tic disorders using internet
Scientific Title:Acronym
Development of psychoeducation program for tic disorders.
Region
| Japan |
Condition
Condition
Tic disorder, Tourette's Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of new psychoeducation program for tic disorder which be able to be delivered on Internet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
GTS-QOL
Key secondary outcomes
Coping for tics, tic symptoms(ATQ/PTQ), Self-esteem
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
online psychoeducational program which contain the four programs and participants watch one for one week.
Interventions/Control_2
Wait list (4 weeks )
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
| 9 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
9 or more years old
Diagnosis of Tourette 's disorder or Chronic tic disorders.
Intellectual ability to understand the content of psychoeducational program.
Key exclusion criteria
Severe depressive symptoms
Suicidal Ideation
Diagnosis of Intellectual Disability
No internet environment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Kano |
Organization
The University of Tokyo
Division name
Graduate shool of medicine
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-5800-8664
kano-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Nonaka |
Organization
The University of Tokyo Hospital
Division name
Department of Child psychiatry
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-5800-8664
Homepage URL
mnonaka@p.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Yukiko Kano
Funding Source
Organization
Ministry of Education, Sports, Science and Technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056981
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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