UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059095 |
|---|---|
| Receipt number | R000067602 |
| Scientific Title | Development and Preliminary Evaluation of a Psychoeducational Video for Adolescents Bereaved by the Death of a Loved One |
| Date of disclosure of the study information | 2025/09/19 |
| Last modified on | 2025/09/16 13:00:42 |
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Basic information
Public title
Development and Preliminary Evaluation of a Psychoeducational Video for Adolescents Bereaved by the Death of a Loved One
Acronym
Development and Preliminary Evaluation of a Psychoeducational Video for Adolescents Bereaved by the Death of a Loved One
Scientific Title
Development and Preliminary Evaluation of a Psychoeducational Video for Adolescents Bereaved by the Death of a Loved One
Scientific Title:Acronym
Development and Preliminary Evaluation of a Psychoeducational Video for Adolescents Bereaved by the Death of a Loved One
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
First, this study aims to develop a psychoeducational video addressing grief reactions among bereaved adolescents and to examine its safety and effectiveness. Second, it aims to clarify the content of support and the needs of adolescents following bereavement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distress and Impact Thermometer (DIT)
Prolonged Grief Disorder (PG-13-Revised)
Common Terminology Criteria for Adverse Events (CTCAE v5.0)
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
Viewing a psychoeducational video
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged between 18 and 24 years at the time of consent.
2. Has experienced the death of a loved one.
3. Bereavement occurred at age 8 or older.
4. At least 13 months have passed since the death.
5. Sufficient ability to understand Japanese.
6. Able to provide written informed consent.
Key exclusion criteria
1. Currently receiving psychiatric, psychosomatic, or counseling treatment.
2. Currently exhibiting suicidal ideation or suicidal behavior (e.g., suicide attempt).
3. Has previously received professional grief care.
4. Scores 13 or higher on the Japanese version of the K6 at screening.
5. Scores 5 or higher on the Brief Grief Questionnaire at screening, or if the investigator determines significant bereavement-related problems.
6. Determined by the investigator to experience excessive physical or psychological burden from participation in the study.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Tamae |
| Middle name | |
| Last name | Inomata |
Organization
Graduate School of Musashino University
Division name
Human and Social Sciences
Zip code
135-8181
Address
3-3-3 Ariake, Koto-ku, Tokyo 135-8181, Japan
TEL
03-5530-7730
g2377002@stu.musashino-u.ac.jp
Public contact
Name of contact person
| 1st name | Tamae |
| Middle name | |
| Last name | Inomata |
Organization
Graduate School of Musashino University
Division name
Human and Social Sciences
Zip code
135-8181
Address
3-3-3 Ariake, Koto-ku, Tokyo 135-8181, Japan
TEL
03-5530-7730
Homepage URL
g2377002@stu.musashino-u.ac.jp
Sponsor or person
Institute
Musashino 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
Research Ethics Committee, Graduate School of Human and Social Sciences, Musashino University
Address
3-3-3 Ariake, Koto-ku, Tokyo 135-8181, Japan
Tel
03-5530-7730
a_gakubu@musashino-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
| 2025 | Year | 09 | Month | 19 | 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
| 2025 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067602
