Tokyo, Sept. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059095) titled 'Development and Preliminary Evaluation of a Psychoeducational Video for Adolescents Bereaved by the Death of a Loved One' on Sept. 19.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Musashino University
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Viewing a psychoeducational video
Eligibility:
Age-lower limit - 18
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 Size - 34
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 04 Day
Anticipated trial start date - 2025 Year 09 Month 19 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067602
Disclaimer: Curated by HT Syndication.