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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030751
Receipt No. 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 2018/01/15

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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
Email 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
Email okuda@omichikai.or.jp

Sponsor
Institute Neurorehabilitation Research Institute, Morinomiya Hospital
Institute
Department

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
Email

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
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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 13 Day
Last follow-up date
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
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034987

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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