UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061382 |
|---|---|
| Receipt number | R000070097 |
| Scientific Title | Process Evaluation of an Online Imagery Rescripting Intervention for School Refusal Children with Distressing School Experiences |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/04/26 22:40:55 |
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Basic information
Public title
Process Evaluation of an Online Imagery Rescripting Intervention for School Refusal Children with Distressing School Experiences
Acronym
Online Imagery Rescripting Intervention for School Refusal Children
Scientific Title
Process Evaluation of an Online Imagery Rescripting Intervention for School Refusal Children with Distressing School Experiences
Scientific Title:Acronym
Online Imagery Rescripting Intervention for School Refusal Children
Region
| Japan |
Condition
Condition
Individuals with school refusal (more than 30 days of non-attendance in the past year)
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
recruitment rate of eligible participants, retention rate, adherence rate of sessions and Presence or Absence of Adverse Event
Key secondary outcomes
for participants
Acceptability of Intervention Measure
Visual Analog Scale for the distress associated with the image
vividness of image
frequency of image for 1 week
Visual Analog Scale for the emotions associated with the image
credibility of the meaning associated with the image
attendance rate
PTSD Checklist for DSM-5
Patient Health Questionnaire-A
Generalized Anxiety Disorder-7
EQ-5D-Y-5L
Heart Rate Variability
satisfaction
Qualitative feedback
for therapist
Fidelity
Intervention Appropriateness Measure
Feasibility of Intervention Measure
Clinical Global Impression
feedback
for parents
cost-effectiveness
Qualitative feedback
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
Online Imagery Rescripting
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
| 10 | years-old | <= |
Age-upper limit
| 15 | 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 sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Mirai |
| Middle name | |
| Last name | Miyoshi |
Organization
university of the ryukyus
Division name
Department of mental health nursing, faculty of medicine
Zip code
901-2720
Address
1076 Kiyuna, Ginowan City, Okinawa, Japan
TEL
098-894-5203
miyoshi_ft5k@cs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Mirai |
| Middle name | |
| Last name | Miyoshi |
Organization
university of the ryukyus
Division name
Department of mental health nursing, faculty of medicine
Zip code
901-2720
Address
1076 Kiyuna, Ginowan City, Okinawa, Japan
TEL
098-894-5203
Homepage URL
miyoshi_ft5k@cs.u-ryukyu.ac.jp
Sponsor or person
Institute
university of the ryukyus
Institute
Department
Personal name
Funding Source
Organization
The Telecommunications Advancement Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
chiba university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus Hospital Clinical Research Support Center
Address
1076 Kiyuna, Ginowan City, Okinawa, Japan
Tel
098-894-1455
creemryukyu@gmail.com
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
琉球大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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
| 2026 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | 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
| 2026 | Year | 04 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070097
