UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000052422
Receipt number R000058807
Scientific Title Evaluation of Intervention Effectiveness Using VR Materials to Reduce Discriminatory Attitudes of College Students Toward Persons with Autism Spectrum Disorders (ASD).
Date of disclosure of the study information 2023/10/05
Last modified on 2024/01/31 21:43:42

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Basic information

Public title

Evaluation of Intervention Effectiveness Using VR Materials to Reduce Discriminatory Attitudes of College Students Toward Persons with Autism Spectrum Disorders (ASD).

Acronym

Evaluation of Intervention Effectiveness Using VR Materials to Reduce Discriminatory Attitudes of College Students Toward Persons with Autism Spectrum Disorders (ASD).

Scientific Title

Evaluation of Intervention Effectiveness Using VR Materials to Reduce Discriminatory Attitudes of College Students Toward Persons with Autism Spectrum Disorders (ASD).

Scientific Title:Acronym

Evaluation of Intervention Effectiveness Using VR Materials to Reduce Discriminatory Attitudes of College Students Toward Persons with Autism Spectrum Disorders (ASD).

Region

Japan


Condition

Condition

Healthy people

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate how college students' perceptions of Autism Spectrum Disorder (ASD) can change over time as they learn more about ASD and figure out what kind of learning is more effective.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Japanese version of the Symbolic Disability Prejudice Scale

Key secondary outcomes

Literacy Scale of Characteristics of Autistic Spectrum Disorder: LS-ASD
Balanced Issue Desirability Response Scale Japanese version (BIDR-J)
Basic attributes


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

The following autism-related education is carried out in the intervention group.
Week 1: Listen to a lecture on ASD
Week 2: Visual experience and support methods using VR
Week 3: Listen to people with ASD
Role play to experience with ASD and support method
Secondary use of data acquired in class

Interventions/Control_2

Students in the comparison group did not receive the same education as in this intervention regarding ASD.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Intervention group: Students in the second year of the Nursing Course of Hiroshima University, School of Medicine, Program of Health Sciences, who have taken "Community and Home Health Nursing Theory" and "Community and Home Health Nursing Practicum I" in 2023, and who have agreed to provide the results of the survey conducted in the said classes and practicum.

Comparison group: Students in their first, third, or fourth year of the Nursing Course of Hiroshima University, School of Medicine, Program of Health Sciences, who voluntarily agreed to participate in the study.
(These students did not receive any education such as this intervention regarding ASD.)

Key exclusion criteria

none

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Michiko
Middle name
Last name Moriyama

Organization

Hiroshima University

Division name

Graduate School of Biomedical and Health Sciences

Zip code

734-8553

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

81-82-257-5367

Email

yasuko-fukushima@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Yasuko
Middle name
Last name Fukushima

Organization

Graduate School of Biomedical and Health Sciences

Division name

Division of Nursing Science

Zip code

734-8553

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

82-257-5365

Homepage URL


Email

yasuko-fukushima@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name

yasukofukushima


Funding Source

Organization

Fumiko Yamaji Foundations

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

Ethical Committee for Epidemiology of Hiroshima University

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

Tel

082-257-1551

Email

iryo-seisaku@office.hiroshima-u.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 10 Month 05 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

95

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

No longer recruiting

Date of protocol fixation

2023 Year 08 Month 17 Day

Date of IRB

2023 Year 08 Month 29 Day

Anticipated trial start date

2023 Year 10 Month 05 Day

Last follow-up date

2023 Year 10 Month 31 Day

Date of closure to data entry

2023 Year 10 Month 31 Day

Date trial data considered complete

2023 Year 10 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 10 Month 05 Day

Last modified on

2024 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058807


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name