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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040056
Receipt No. 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 2020/04/04

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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
Email 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
Email kerosuke3@gmail.com

Sponsor
Institute Adolescent Mental Health Service, Biwako Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 31 Day
Date of IRB
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
2020 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045670

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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