UMIN-CTR Clinical Trial

Basic information
Public title	Adolescent health promotion through health supervision and mobile technology
Acronym	Adolescent health supervision / CBT application
Scientific Title	Adolescent health promotion through health supervision and mobile technology
Scientific Title:Acronym	Adolescent health supervision / CBT application
Region	Japan

Condition
Condition	Well-child
Classification by specialty	Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Promotion for adolescent health by health supervision and CBT application
Basic objectives2	Others
Basic objectives -Others	Stress coping with help seeking behavior and self-monitoring
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To promote adolescent health
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	1) Adolescent Health Supervision group Observaiton period: 4 months
Interventions/Control_2	2) Adolescent Health Supervision and Cognitive Behavioral Therapy group Observaiton period: 4 months
Interventions/Control_3	3) Non interventional group Observaiton period: 4 months
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	13 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Children showing consent to attend this project 2. Children's caregivers showing consent to attend this project 3. Children's age: ranged from 13 to 18 4. Having a smartphone
Key exclusion criteria	1. Children having depressive symptoms 2. Children being suspected as depression or suicidal ideation by psychometric profiles 3. Children who were judged as inappropriate subjects by researcher
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Shinichiro Middle name Last name Nagamitsu
Organization	Kurume University School of Medicine
Division name	Department of Pediatrics & Child Health
Zip code	8300011
Address	67 Asahi-machi Kurume city
TEL	0942317565
Email	kaoru@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Nagamitsu
Organization	Kurume University School of Medicine
Division name	Department of Pediatrics & Child Health
Zip code	8300011
Address	67 Asahi-machi Kurume city
TEL	0942317565
Homepage URL	http://www.amed-teen.com/
Email	kaoru@med.kurume-u.ac.jp

Sponsor
Institute	Department of Pediatrics & Child Health, Kurume University school of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	Kurume University Hospital Clinical Trial Center
Address	67 Asahi machi Kurume city
Tel	0942317201
Email	rinsyou-cen@kurume-u.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	2019 Year 04 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	No longer recruiting
Date of protocol fixation	2019 Year 03 Month 12 Day
Date of IRB	2019 Year 03 Month 12 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2020 Year 03 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	2019 Year 03 Month 29 Day
Last modified on	2019 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041246