UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040056 |
|---|---|
| Receipt number | R000045670 |
| Scientific Title | Research of involved factors for the outcome of the treatment in child and adolescent mental health services |
| Date of disclosure of the study information | 2020/04/04 |
| Last modified on | 2021/04/05 17:30:34 |
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Basic information
Public title
Research of involved factors for the outcome of the treatment in child and adolescent mental health services
Acronym
IF-CAMHS
Scientific Title
Research of involved factors for the outcome of the treatment in child and adolescent mental health services
Scientific Title:Acronym
IF-CAMHS
Region
| Japan |
Condition
Condition
Psychiatric Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is known that stigma, adversity, duration of untreated mental illness (DUI), and the mental health of parents affect outcomes in child adolescent psychiatry. However, no studies have comprehensively evaluated these.
Basic objectives2
Others
Basic objectives -Others
In this study, we clarify the correlation between treatment outcome (QOL, mental symptoms, treatment satisfaction) and stigma, adversity experience, DUI, and parental mental health.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL
Key secondary outcomes
Severity, adversity experience, parental stigma, parental mental health, duration of untreated illness
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients who first visited Biwako Hospital
Key exclusion criteria
Patients who do not wish to receive treatment at Biwako Hospital
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | Inagaki |
| Last name | Inagaki |
Organization
Biwako Hospital
Division name
Adolescent Mental Health Service
Zip code
520-2153
Address
1-8-5, Sakamoto, Otsu, Shiga
TEL
077-578-2023
kerosuke3@gmail.com
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | Inagaki |
| Last name | Inagaki |
Organization
Biwako Hospital
Division name
Adolescent Mental Health Service
Zip code
520-2153
Address
1-8-5, Sakamoto, Otsu, Shiga
TEL
077-578-2023
Homepage URL
kerosuke3@gmail.com
Sponsor or person
Institute
Adolescent Mental Health Service, Biwako Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Biwako Howpital
Address
1-8-5, Sakamoto, Otsu, Shiga
Tel
077-578-2023
kerosuke3@gmail.com
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
琵琶湖病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 04 | 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
| 2020 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At the first consultation, 6 to 8 weeks period, 12 to 16 weeks period, 24 to 28 weeks period, 36 to 48 weeks period and 36 to 40 weeks period, we will assess we will evaluate the following items as shown below.
For patients: Peds-QL for patients, ACE questionnaire and GHQ 30
For parents: Peds-QL for parents, DDS and K6
Management information
Registered date
| 2020 | Year | 04 | Month | 04 | Day |
Last modified on
| 2021 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045670
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
