UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027647
Receipt number R000031674
Scientific Title Development of a Bangladeshi version of a schizophrenia educational awareness program
Date of disclosure of the study information 2017/07/10
Last modified on 2023/06/21 16:42:28

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Basic information

Public title

Development of a Bangladeshi version of a schizophrenia educational awareness program

Acronym

Intervention study

Scientific Title

Development of a Bangladeshi version of a schizophrenia educational awareness program

Scientific Title:Acronym

Intervention study

Region

Asia(except Japan)


Condition

Condition

Schizophrenia

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to improve mental health in Bangladesh by developing an educational program for early detection and increased awareness of schizophrenia.We plan to modify an existing Japanese educational awareness program that helps parents of adolescent children to better understand schizophrenia and identify the disorder early, when it is easiest to treat.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Help-seeking

Key secondary outcomes

Basic knowledge of schizophrenia
Discrimination of symptom
Attitude


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Educational program

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cardiff International School, Mohammadpur
Preparatory School, Residential Model School & College, Firoza Bashar Ideal School and College , S.F.X. Green Herald International School, other (Parents of students).
There is an agreement to answer questions about schizophrenia.

Key exclusion criteria

Less than 20 years old

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Hatsumi
Middle name -
Last name Yoshii

Organization

Tohoku University, Graduate School of Medicine

Division name

Health Sciences

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan

TEL

022-717-7954

Email

hatsumi@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Hatsumi
Middle name -
Last name Yoshii

Organization

Tohoku University, Graduate School of Medicine

Division name

Health Sciences

Zip code

980-8575

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan

TEL

022-717-7954

Homepage URL


Email

hatsumi@med.tohoku.ac.jp


Sponsor or person

Institute

Health Sciences, Tohoku University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Thikana psychiatric/ Drug Addiction Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University Graduate School of Medicine Ethics Committee

Address

2-1 seiryo-machi, Aoba-ku,Sendai-City, Japan

Tel

0227178007

Email

med-kenkyo@grp.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

2017 Year 07 Month 10 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

809

Results

Parents of adolescents with basic knowledge of schizophrenia facilitated help seeking.

Results date posted

2023 Year 06 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Parents of adolescents

Participant flow

Parents of secondary school students and hight school students who agree to participate.

Adverse events

None

Outcome measures

Basic knowledge, attitudes and help-seeking regarding schizophrenia.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 05 Month 21 Day

Date of IRB

2015 Year 05 Month 01 Day

Anticipated trial start date

2015 Year 06 Month 02 Day

Last follow-up date

2021 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2025 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2017 Year 06 Month 05 Day

Last modified on

2023 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031674


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name