UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021535 |
|---|---|
| Receipt number | R000024814 |
| Scientific Title | Mental health status of caregivers supporting children with special health care needs(CSHCN) |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2021/09/21 14:14:52 |
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Basic information
Public title
Mental health status of caregivers supporting children with special health care needs(CSHCN)
Acronym
Mental health status of caregivers supporting children with special health care needs(CSHCN)
Scientific Title
Mental health status of caregivers supporting children with special health care needs(CSHCN)
Scientific Title:Acronym
Mental health status of caregivers supporting children with special health care needs(CSHCN)
Region
| Japan |
Condition
Condition
Children with special health care needs (CSHCN)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate validity of Patient Health Questionnnaire-2, 9(PHQ-2, 9) to screen caregivers of children with special health care needs(CSHCN) for depression.
Basic objectives2
Others
Basic objectives -Others
To investigate association between depression screening results and medical and social factors surrounding CSHCN and their caregivers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
PatientHealth Questionnaire-2(PHQ-2), Patient Health Questionnaire-9(PHQ-9)
Key secondary outcomes
Parent Stress Index Short Form (PSI-SF), Functional Independence Measure for Children (WeeFIM)
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Questionnaires
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
| 6 | months-old | <= |
Age-upper limit
| 96 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Caregivers supporting children with special health care needs who visit Department of Pediatrics at Kameda Medical Clinic (Kamogawa, Chiba, Japan) and fulfill one or more of the following conditions: 1)children with chronic pediatric diseases of specified categories designated by the Minister of Health, Labour and Welfare, Japan; 2)children who have Rehabilitation Certificate; 3)children who have Physical Disability Certificate; 4)children who require home medical devices including home oxygen therapy, home mechanical ventilation, tracheotomy tube, home tubal feeding, urethral catheterization; 5)children who require rehabilitation therapy.
Key exclusion criteria
Children whose caregivers do not wish to participate in the study will be excluded regardless of inclusion criteria status.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Obikane |
Organization
Kameda Medical Center
Division name
Department of Pediatrics
Zip code
2968602
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
TEL
41+4-7092-2211
eko-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Obikane |
Organization
Kameda Medical Center
Division name
Department of Pediatrics
Zip code
2968602
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
TEL
41+4-7092-2211
Homepage URL
eko-tky@umin.ac.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center
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
Kameda Medical Center
Address
929 Higashi-cho, Kamogawa, Chiba, Japan
Tel
41+4-7092-2211
clinical_research@kameda.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
亀田クリニック
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 18 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a cross-sectional study to evaluate association between caregivers' mental health state and medical/social factors of children with special health care needs(CSHCN).
Management information
Registered date
| 2016 | Year | 03 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024814
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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