UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030751 |
|---|---|
| Receipt number | R000034987 |
| Scientific Title | A controlled pilot study for evaluating the effects of a psychoeducational program for parents with cerebral palsy children |
| Date of disclosure of the study information | 2018/01/10 |
| Last modified on | 2020/01/31 17:30:53 |
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Basic information
Public title
A controlled pilot study for evaluating the effects of a psychoeducational program for parents with cerebral palsy children
Acronym
A controlled pilot study for evaluating the effects of a psychoeducational program for parents with cerebral palsy children
Scientific Title
A controlled pilot study for evaluating the effects of a psychoeducational program for parents with cerebral palsy children
Scientific Title:Acronym
A controlled pilot study for evaluating the effects of a psychoeducational program for parents with cerebral palsy children
Region
| Japan |
Condition
Condition
Cerebral palsy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this pilot study it to confirm a feasibility of multi center RCT to test the efficacy of a psychoeducational treatment, in targeting children with cerebral palsy and their parents' quality of life and parenting distress in families.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Parents: PSI
Children: CP-QOL
Key secondary outcomes
EQ-5D-5L
PHQ-9
GAD-7
KIDSCREEN-10
SDQ
FACES 3
adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions: Psychoeducational program (90 min. x 6, in 12weeks) / Waiting control: Ordinary treatment
Interventions/Control_2
Waiting control: Psychoeducational program (90 min. x 6, in 12weeks)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
primary-care giver for children with cerebral palsy aged 2 - 12 years old
Key exclusion criteria
persons who have physical and/or psychological disorder
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaeko Ogura |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
Address
2-1-88,Morinomiya ,Joto-ku, Osaka, Osaka, Japan
TEL
06-6969-0111
ogurakaeko@icloud.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Okuda |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
Address
2-1-88,Morinomiya ,Joto-ku, Osaka, Osaka, Japan
TEL
06-6969-0111
Homepage URL
okuda@omichikai.or.jp
Sponsor or person
Institute
Neurorehabilitation Research Institute, Morinomiya Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | Month | 10 | 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
81
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
| 2017 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2020 | 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 | 01 | Month | 10 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034987
