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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035285
Receipt No. R000040192
Scientific Title Effect of modified parent training for parents of children with neurodevelopmental disorders in hospital setting: a pilot study
Date of disclosure of the study information 2018/12/17
Last modified on 2019/08/01

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Basic information
Public title Effect of modified parent training for parents of children with neurodevelopmental disorders in hospital setting: a pilot study
Acronym Modified parent training in hospital setting: a pilot study
Scientific Title Effect of modified parent training for parents of children with neurodevelopmental disorders in hospital setting: a pilot study
Scientific Title:Acronym Modified parent training in hospital setting: a pilot study
Region
Japan

Condition
Condition Neurodevelopmental disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effect of modified parent training for parents of children with neurodevelopmental disorders
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in quality of life (QOL) using the KINDL
Key secondary outcomes

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
Behavior,custom
Interventions/Control_1 Modified parent training
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
7 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Patients with neurodevelopmental disorders and parents
Key exclusion criteria Parents who can't participate in all the programs
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yamashita
Middle name
Last name Hiroshi
Organization Kyushu University Hospital
Division name Department of Child Psychiatry
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5624
Email h-yama03@npsych.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Katsuki
Middle name
Last name Daisuke
Organization Kyushu University Hospital
Division name Department of Child Psychiatry
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5624
Homepage URL
Email 3MD15041T@s.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Fukuoka prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Section of IRB & Ethics Committee Administration, Academic Research Support Division, Kyushu University Hospital
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel 092-642-5082
Email byskenkyu@jimu.kyushu-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
2018 Year 12 Month 17 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 10
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
2018 Year 12 Month 10 Day
Date of IRB
2018 Year 12 Month 10 Day
Anticipated trial start date
2018 Year 12 Month 17 Day
Last follow-up date
2019 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
2018 Year 12 Month 17 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040192

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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