UMIN-ICDS Clinical Trial

Public title

Knowledge and understanding of mental health in caregivers (cluster randomized controlled trial)

Acronym

Knowledge and understanding of mental health in caregivers (cluster RCT)

Scientific Title

Mental health literacy for caregivers (cluster randomized controlled trial)

Scientific Title:Acronym

Mental health literacy for caregivers (cluster RCT)

Region

Japan

Condition

Mental health literacy

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness of a mental health literacy educational program developed for caregivers of adolescents.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Mental health literacy will be assessed using a self-reported questionnaire as follows.

General knowledge about mental health and illnesses will be assessed using items developed for this study by the authors.

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) stigmatizing attitude towards their child, (2) intention to help their child, will be assessed. For the assessment of (1), some question items will be adapted from the "weak-not-sick" items of the Depression Stigma Scale (Yap et al., 2014). The items and the answer choices that are appropriate to ask caregivers in Japan will be selected, and the wording will be modified so that it is more suitable for them. For (2), items developed for this study will be used.

Acceptance when their child is diagnosed with a mental illness will be assessed using an item developed for this study.

The outcome will be assessed at before and immediately after the intervention.

Yap et al., International Journal of Methods in Psychiatric Research.2014;23(1):49-61.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Intervention group
A program regarding mental health literacy will be delivered. 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 is associated with lifestyle, (4) how adults need to deal with child's mental health problems.

Interventions/Control_2

Control group
A program regarding the appropriate use of smartphones and tablets will be delivered. Topic of the program will include how to prevent their child's overuse of smartphones.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Caregivers of students in junior and senior high schools.

Key exclusion criteria

People whose mother tongue is not Japanese.

Target sample size

1000

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

Email

psytokyo@yahoo.co.jp

Name of contact person

1st name	Sasaki
Middle name
Last name	Tsukasa

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

Email

psytokyo@yahoo.co.jp

Institute

The University of Tokyo

Institute

Department

Personal name

Tsukasa Sasaki

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee of the University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8654

Tel

03-5841-0284

Email

lifescience.adm@gs.mail.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

01

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

1835

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

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

01

Month

18

Day

Date of IRB

2022

Year

12

Month

16

Day

Anticipated trial start date

2023

Year

01

Month

27

Day

Last follow-up date

2023

Year

04

Month

28

Day

Date of closure to data entry

2023

Year

07

Month

26

Day

Date trial data considered complete

Date analysis concluded

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 caregivers"), since only caregivers will be targeted to this study.

Registered date

2023

Year

01

Month

23

Day

Last modified on

2024

Year

02

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057070