UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045670