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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036343
Receipt No. R000041246
Scientific Title Adolescent health promotion through health supervision and mobile technology
Date of disclosure of the study information 2019/04/01
Last modified on 2019/09/29

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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/ctr_e/ctr_view.cgi?recptno=R000041246

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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