UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048972 |
|---|---|
| Receipt number | R000055776 |
| Scientific Title | Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2022/09/20 |
| Last modified on | 2023/04/04 15:49:31 |
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Basic information
Public title
Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Acronym
Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Scientific Title
Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Scientific Title:Acronym
Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Healthy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of film-based intervention on SRH seeking intention of Cambodian youth aged 18-24 in Cambodia.
Basic objectives2
Others
Basic objectives -Others
- Examine the effects of film-based intervention on SRH seeking behavior of Cambodian youth aged 18-24 in Cambodia
- Determine the perception of Cambodian youth, aged 18-24 in Cambodia, on the accessibility and reliability of sources of SRH information
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The outcomes for this study are SRH seeking intention and behavior. SRH seeking intention is the desire to find SRH information, whereas SRH seeking behavior is performing the action of actively looking for SRH information from various sources. Their SRH seeking intention and behavior will be measured by their level of self-efficacy towards finding SRH information and perception of the level of reliability and accessibility of sources of SRH information.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants of the intervention arm will first be introduced to the title of the film, which will hint the main topic(s) of the intervention. Participants will continue to watch the film just as they would when consuming an online video. The film will explore the character's issue as the story unfolds. However, the participants will be presented with the story in a way that is dramatic and urgent that can be somewhat personal within the context of film, and allows for the participant to be more empathetic with the character. The film will not only show the character facing the problem, but will also show the methods and steps that the character in the film takes to solve the issue. At the end of the film intervention, contact information to a local youth-friendly service will be provided to the participant.
Interventions/Control_2
Participants of the control arm will first be introduced to the main topic(s) of the text-based intervention. They will start reading the text-based intervention in which a character is faced with a SRH related situation. The scenario will continue to elaborate the chracter's issue until the end of the story. Then, the participant will be presented with possible steps that the character should take to approach the issue. Ultimately, contact information to a local youth-friendly service will be available at the end of the intervention.
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants of this study will be youths aged 18 to 24 who are living in Cambodia and have access to the Internet via a personal computer or a smartphone at the time of data collection.
Key exclusion criteria
Those who are unable to watch the film intervention, read the text-based intervention, respond to questions in Khmer language, and/or are not able to use the Internet will be excluded from the study.
Target sample size
334
Research contact person
Name of lead principal investigator
| 1st name | Inrasothythep |
| Middle name | |
| Last name | Neth |
Organization
The University of Tokyo
Division name
Department of Community and Global Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
070-4422-5240
inrasothythep.neth@gmail.com
Public contact
Name of contact person
| 1st name | Inrasothythep |
| Middle name | |
| Last name | Neth |
Organization
The University of Tokyo
Division name
Department of Community and Global Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
070-4422-5240
Homepage URL
inrasothythep.neth@gmail.com
Sponsor or person
Institute
Not applicable
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (21H03160)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan, 113-0033
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2022 | Year | 09 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055776
