UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052561
Receipt number R000059971
Scientific Title Research on sexuality education for students with intellectual disabilities
Date of disclosure of the study information 2023/10/23
Last modified on 2024/10/21 14:47:07

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Basic information

Public title

Research on sexuality education for students with intellectual disabilities

Acronym

Research on sexuality education for students with intellectual disabilities

Scientific Title

Research on sexuality education for students with intellectual disabilities

Scientific Title:Acronym

Research on sexuality education for students with intellectual disabilities

Region

Japan


Condition

Condition

NON

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Through the tutoring of sexuality education, we will reveal how students and teachers experience each other and the meanings that arise in the process.

Basic objectives2

Others

Basic objectives -Others

Meaning of Phenomena

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Do the qualitative data obtained provide new insights and understanding?

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

Provide individualized instruction in sexuality education using original teaching materials.

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

15 years-old <

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

Eligible applicants must be enrolled in the upper secondary school of a special needs school for the students with intellectual disabilities, have a mild intellectual disability, and be able to communicate verbally.

Key exclusion criteria

If you have experienced sexual trauma in the past.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name naoko
Middle name
Last name tsuruoka

Organization

Tokyo Healthcare University

Division name

Wakayama Faculty of Nursing

Zip code

6408269

Address

4-20 Komatsubaradori, Wakayama City, Wakayama Prefecture

TEL

0734355820

Email

n-tsuruoka@thcu.ac.jp


Public contact

Name of contact person

1st name naoko
Middle name
Last name tsuruoka

Organization

Tokyo Healthcare University

Division name

Wakayama Faculty of Nursing

Zip code

6408269

Address

4-20 Komatsubaradori, Wakayama City, Wakayama Prefecture

TEL

0734355820

Homepage URL


Email

n-tsuruoka@thcu.ac.jp


Sponsor or person

Institute

Tokyo Healthcare University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Healthcare University Ethics Committee on Human Research

Address

4-1-17 Higashi-Gotanda, Shinagawa-ku, Tokyo

Tel

03-5421-7656

Email

rinri@thcu.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 23 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

2023 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2023 Year 10 Month 23 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 10 Month 20 Day

Last modified on

2024 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059971