UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058747 |
|---|---|
| Receipt number | R000067172 |
| Scientific Title | A research study on psychological education textbooks for children living with parents who are undergoing psychiatric treatment |
| Date of disclosure of the study information | 2025/08/09 |
| Last modified on | 2025/08/09 10:55:08 |
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Basic information
Public title
Research survey for parents regarding the psychological education textbook: Books That May Help You (Short Version)
Acronym
ATB-P research
Scientific Title
A research study on psychological education textbooks for children living with parents who are undergoing psychiatric treatment
Scientific Title:Acronym
Text for COPMI: Parent Survey
Region
| Japan |
Condition
Condition
The target population consists of parents raising children with mental disorders who are outpatients at pediatric or psychiatric departments of research institutions, and who themselves have mental disorders.
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether a psychological education text titled: A Book That Might Help You (Short Version). designed for elementary school students in the lower grades can serve as a source of reassurance for parents with mental illnesses who are beginning or already engaged in child-rearing. Additionally, we aim to clarify the potential of this text to contribute to improving attachment and help-seeking abilities in parent-child dyads where one or both parents have mental illnesses.
Basic objectives2
Others
Basic objectives -Others
By utilizing this text from an early age, we expect to reduce parents' feelings of guilt toward their children and alleviate tension that often arises in parent-child relationships. As a result, we expect that not only will the bond between parents and children be strengthened, but both parents and children will improve their ability to seek support from those around them. At the same time, this study will examine the role of such texts in promoting more effective parenting attitudes and reducing parenting stress.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in attitudes toward explaining mental illness to children
Key secondary outcomes
1. Relationship between K6 (psychiatric symptoms), help-seeking attitudes, positive and negative parenting attitudes, and stressors experienced by parents of children with developmental disorders
2. Relationship between measures of children's strengths and difficulties, help-seeking attitudes, positive and negative parenting attitudes, and stressors experienced by parents of children with developmental disorders
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
Read A Book That May Help You (Short Version), a psychological education text for children of parents with mental illness.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Parents of patients currently receiving outpatient or inpatient treatment at the Department of Psychiatry and Pediatrics at Kurume University Hospital, the Department of Pediatrics and Psychiatry at Fukuoka University Hospital, or the Children's Mental Health Center at Dokkyo Medical University Saitama Medical Center, who have a mental disorder and are currently undergoing treatment
(2) The age of the child of the subject is between 0 and 20 years old
(3) Individuals who have obtained permission from the child's attending physician
(4) Individuals who have received written explanation about this study and have provided written consent.
Key exclusion criteria
(1) If reading the psychological education text is deemed invasive
(2) If permission from the attending physician cannot be obtained
(3) If the patient's understanding of Japanese is insufficient
(4) If there are significant intellectual challenges in understanding the text
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Matsuoka |
Organization
Kurume University
Division name
Department of Neuropsychiatry, School of Medicine
Zip code
8300011
Address
67 Asahi-machi, Kurume-shi, Fukuoka
TEL
0942-31-7564
matsuoka_michiko@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Matsuoka |
Organization
Kurume University
Division name
Department of Neuropsychiatry, School of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka
TEL
0942-31-7564
Homepage URL
matsuoka_michiko@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Michiko Matsuoka
Funding Source
Organization
Japanese Society of Psychosomatic Pediatrics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University Medical Ethics Committee
Address
67 Asahi-machi, Kurume-shi, Fukuoka
Tel
0942-65-3749
i_rinri@kurume-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 | 08 | Month | 09 | 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
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067172
