UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046719 |
|---|---|
| Receipt number | R000053255 |
| Scientific Title | Mental health literacy for parents |
| Date of disclosure of the study information | 2022/01/25 |
| Last modified on | 2023/02/02 16:05:41 |
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Basic information
Public title
Knowledge and understanding of mental health in parents
Acronym
Knowledge and understanding of mental health in parents
Scientific Title
Mental health literacy for parents
Scientific Title:Acronym
Mental health literacy for parents
Region
| Japan |
Condition
Condition
Mental health literacy
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a mental health literacy educational program developed for parents of adolescents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental health literacy will be assessed using a self-reported questionnaire as follows.
1. General knowledge about mental health and illnesses such as lifetime-prevalence of mental illnesses, increase of mental illnesses in teens, and association between school life or sleep habits and mental health, will be assessed using items developed for this study by the authors.
2. After reading a vignette which describes a student with depression, and assuming that a child of respondents is in the same situation as the student in the vignette, (1) intention to deal with their child, (2) what they feel when their child is diagnosed to have a mental illness, and (3) stigmatizing attitude towards the state of their child, will be assessed. For the assessment of (1) and (2), items developed for this study will be used. For (3), some question items will be adapted from the "weak-not-sick" subscale of the Depression Stigma Scale (Yap et al., 2014). Among this scale, the items and the answer choices that are appropriate to ask parents in Japan will be selected, and the wording of the items and the answer choices will be modified so that the wordings are more suitable for parents in Japan.
Each outcome will be assessed at immediately before and after the intervention.
Yap et al., International Journal of Methods in Psychiatric Research.2014;23(1):49-61.
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
Uncontrolled
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
One 15-minute program regarding mental health literacy will be delivered. The program will be taught using slides with narration and an animated film. Main topics of the program will be as follows: (1) the prevalence of mental illnesses increases in teens, (2) mental illnesses are common diseases that are experienced by 1 in 5 people, (3) mental health problems are associated with lifestyle, (4) how adults need to deal with child's mental health problems.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parents of students in junior and senior high schools.
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Sasaki |
Organization
The University of Tokyo
Division name
Department of Physical and Health Education, Graduate School of Education
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3985
psytokyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Sasaki |
Organization
The University of Tokyo
Division name
Department of Physical and Health Education, Graduate School of Education
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3985
Homepage URL
psytokyo@yahoo.co.jp
Sponsor or person
Institute
Department of Physical and Health Education, Graduate School of Education, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Research Ethics Committee of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0284
lifescience.adm@gs.mail.u-tokyo.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
| 2022 | Year | 01 | Month | 25 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 25 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Scientific Title of the present registration is different from the title submitted to the research ethics committee ("Mental health literacy for school teachers and parents"), since only parents will be targeted to this study.
Management information
Registered date
| 2022 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053255
