UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037573 |
|---|---|
| Receipt number | R000042834 |
| Scientific Title | Effect of modified parent training for parents of children with neurodevelopmental disorders in hospital setting: a randomized controlled trial |
| Date of disclosure of the study information | 2019/08/05 |
| Last modified on | 2023/03/18 18:53:39 |
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Basic information
Public title
Effect of modified parent training for parents of children with neurodevelopmental disorders in hospital setting: a randomized controlled trial
Acronym
Modified parent training in hospital setting: a randomized controlled trial
Scientific Title
Effect of modified parent training for parents of children with neurodevelopmental disorders in hospital setting: a randomized controlled trial
Scientific Title:Acronym
Modified parent training in hospital setting: a randomized controlled trial
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
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Modified parent training
Interventions/Control_2
Treatment as usual
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
Children
1. Subjects with neurodevelopmental disorders
2. Aged 6 years or older, and aged 12 years or younger
3. Subjects who give consent in the participation
Parents
1. Subjects who give consent in the participation
Key exclusion criteria
Children
1. No intellectual disability
Parents
1. No psychiatric disorder
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamashita |
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
h-yama03@npsych.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Katsuki |
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
d.katsuki.a26@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
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
| 2019 | Year | 08 | Month | 05 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042834
