UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032638
Receipt number R000037014
Scientific Title Educational intervention to improve active listening skills in medical school for suicide prevention: A randomized controlled trial
Date of disclosure of the study information 2018/05/18
Last modified on 2018/05/18 17:17:02

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Basic information

Public title

Educational intervention to improve active listening skills in medical school for suicide prevention: A randomized controlled trial

Acronym

Educational intervention to improve active listening skills in medical school for suicide prevention: A randomized controlled trial

Scientific Title

Educational intervention to improve active listening skills in medical school for suicide prevention: A randomized controlled trial

Scientific Title:Acronym

Educational intervention to improve active listening skills in medical school for suicide prevention: A randomized controlled trial

Region

Japan


Condition

Condition

Suicidal Ideation

Classification by specialty

Psychosomatic Internal Medicine Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To show the effectiveness of an educational program for medical students to improve active listening skills using educational material

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Active listening skills of medical students

Key secondary outcomes

Knowledge of active listening, and self-efficacy


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Watch DVD regarding communication with persons in psychological crisis, and DVD regarding good and bad listening skills.

Interventions/Control_2

Watch DVD intended to facilitate parental child care, and DVD regarding infant crying and shaken baby syndrome.

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

The 4th grades medical students in Tokyo medical and dental university.

Key exclusion criteria

Student not present in a class.

Target sample size

105


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeo Fujiwara

Organization

Tokyo Medical and Dental University

Division name

Grobal Health Promotion

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-6111

Email

fujiwara.hlth@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuri Hiramoto

Organization

Tokyo Medical and Dental University

Division name

Grobal Health Promotion

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-6111

Homepage URL


Email

hiramoto.hlth@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 05 Month 18 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

2018 Year 05 Month 18 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 18 Day

Last modified on

2018 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037014


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name