UMIN-CTR Clinical Trial

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
Email	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
Email	eko-tky@umin.ac.jp

Sponsor
Institute	Kameda Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024814