UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052125 |
|---|---|
| Receipt number | R000059494 |
| Scientific Title | Research on Mental Health Care by Digital System for Children and Adolescents |
| Date of disclosure of the study information | 2023/09/11 |
| Last modified on | 2023/09/05 21:06:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on Mental Health Care by Digital System for Children and Adolescents
Acronym
Digital Mental Health Care for Children and Adolescents
Scientific Title
Research on Mental Health Care by Digital System for Children and Adolescents
Scientific Title:Acronym
Digital Mental Health Care for Children and Adolescents
Region
| Japan |
Condition
Condition
depression symptom; anxiety symptom; stress
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the psychological state of children and adolescents using a smartphone application and to investigate the effectiveness of a psychological state improvement program based on the results of the applicatio
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychological test forms such as Depression, Anxiety, Stress (DASS)-21 before and after the use of the smartphone application show improvement in psychological status.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use of a smartphone application that estimates the state of psychological improvement and suggests psychological state programs based on this estimation.
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
| 15 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have indicated their willingness to participate in the study and have agreed to participate in the study based on their understanding of the explanation.
Age of participants is over 15 years old and under 30 years old
For the application use group, applicants whose private smartphone is an iPhone (iOS 13 or higher, iPhone 8 or higher), have at least approximately 800 MB of free space, and are able to install the specified applications.
Key exclusion criteria
Those who are taking medications on a daily basis that may affect the evaluation of this study (medications claiming to improve fatigue, stress, or sleep).
Hearing problems that interfere with daily life.
Participants in other intervention studies.
Other subjects deemed inappropriate by the study staff.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Okuyama |
Organization
Tohoku University Hospital
Division name
rehabilitation
Zip code
980-8574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Japan
TEL
022-717-7353
junko.okuyama@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Okuyama |
Organization
Tohoku University Hospital
Division name
Rehabilitation
Zip code
980-8574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Japan
TEL
022-717-7353
Homepage URL
junko.okuyama@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Junko Okuyama
Funding Source
Organization
MEXT
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
Tohoku University Hospital
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Japan
Tel
0227177353
junko.okuyama@med.tohoku.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
| 2023 | Year | 09 | Month | 11 | 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
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059494
