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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name