Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061382) titled 'Process Evaluation of an Online Imagery Rescripting Intervention for School Refusal Children with Distressing School Experiences' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - university of the ryukyus
Condition:
Condition - Individuals with school refusal (more than 30 days of non-attendance in the past year)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to comprehensively examine the feasibility and safety of an online support program, Imagery Rescripting, for students who have become school-refusing due to distressing school experiences.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Online Imagery Rescripting
Eligibility:
Age-lower limit - 10
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Children aged 10 to 15 years (from 5th grade of elementary school to 3rd grade of junior high school)
2. Individuals experiencing school refusal (defined as absence from school for 30 or more days in the past year) associated with distressing school experiences
3. A distress level of 30 or higher (on a screening measure) related to school-related distressing experiences
4. Provision of informed consent from both the participant and their parent/guardian
5. Currently receiving care at the University of the Ryukyus Hospital
6. Access to the internet (via computer, smartphone, or tablet)
7. Ability to participate in the online program once a week for seven consecutive weeks
8. Availability of a parent/guardian at home or reachable immediately during sessions for emergency support
9. Native Japanese speakers who are able to understand explanations in Japanese and provide informed consent voluntarily
Key exclusion criteria - 1. Individuals with a diagnosis of psychotic disorders (including schizophrenia), intellectual disability, bipolar I disorder, eating disorders, substance use disorders, or personality disorders
2. Individuals with a history of neurological injury (e.g., cerebrovascular disease, brain tumor, or traumatic brain injury)
3. Individuals at imminent risk of suicide (defined as a score of 2 or higher on Item 9 of the PHQ-A)
4. Individuals whose type or dosage of prescribed medication for mental health problems has been changed within the past two months at the time of program entry, or who are expected to have changes during the study period
5. Individuals who plan to receive other psychological interventions during the program (including school counseling)
6. Individuals with whom it is difficult to maintain contact
7. Individuals deemed unsuitable for safe participation in this study by the principal investigator or study staff
Target Size - 5
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 26 Day
Anticipated trial start date - 2026 Year 08 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070097
Disclaimer: Curated by HT Syndication.
