UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041306
Receipt No. R000047162
Scientific Title Effectiveness of online health guidance program based on cognitive behavioral therapy(CBT for Parent to Support Accepting Children's Uniqueness: CBT-PAC)for parent to understand children with autism spectrum tendency and deal with parenting stress:A pilot study
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effectiveness of online health guidance program based on cognitive behavioral therapy(CBT for Parent to Support Accepting Children's Uniqueness: CBT-PAC)for parent to understand children with autism spectrum tendency and deal with parenting stress:A pilot study
Acronym CBT-PAC
Scientific Title Effectiveness of online health guidance program based on cognitive behavioral therapy(CBT for Parent to Support Accepting Children's Uniqueness: CBT-PAC)for parent to understand children with autism spectrum tendency and deal with parenting stress:A pilot study
Scientific Title:Acronym CBT-PAC
Region
Japan

Condition
Condition A parent of child with suspected Autism spectrum
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of online health guidance CBT program for parenting resilience of parents with suspected autism spectrum child aged 2 to 3 by the single arm pilot study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Development and Evaluation of a Parenting Resilience Elements Questionnaire(PREQ)
Key secondary outcomes (1)Parenting Stress Index(PSI)
(2)The General Health Questionnaire(GHQ-28)
(3)State-Trait Anxiety Inventory-JYZ(STAI)
(4)Eyberg Child Behavior Inventory(ECBI)
(5)Ministry of Health, Labor and Welfare Maternal and Child Health Guidelines Healthy Parents and Children 21(Secondary)Question 4 items

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
Maneuver
Interventions/Control_1 The health guidance using cognitive behavioral model
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)A parent with child aged between 2 to 3
(2)Child met ASD criteria in M-CAT.
(3)Individual with the score above"190.6"in PSI.
(4)Indivudal who falls under any of the following:"has no died/self-harm consideration,"has not" or "has had a moment"in GHQ-28.
(5)Individual who understands the explanation and has consent.
(6)Individual who have an access to internet and computer environment
(7)Individual taking health guidance from the government and not planned to start a new drug therapy (psychiatric field)during the test period.
(8)Individual have a mental and physical condition enough to take the program continuously.
(9)Individual who have not received other cognitive behavioral therapy during the study period.
(10)Individual who can participate in the weekly CBT program.
Key exclusion criteria 1) Individual with who have an organic disorder,have serious psychicalpsycical disorder.(in five years)
2) Individual who have low IQ(under 89 of VIQ)
3)individual who are receiving medical treatment in psychiatry.
4)Individual with antisocial conditions.
5) Individual with serious psychical disorder.
6)Individual who is judged inappropriate to participate by the researchers
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Shimizu
Organization Chiba University
Division name Research Center for Child Mental Development; Department of Cognitive Behavioral Physiology; Cognitive Behavioral Therapy Center
Zip code 260-8670
Address 1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba , Japan
TEL 043-226-2028
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Kawasaki
Organization Chiba University
Division name Research Center for Child Mental Development; Department of Cognitive Behavioral Physiology
Zip code 260-8670
Address 1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba , Japan
TEL 043-226-2028
Homepage URL
Email tomoko-kawasaki.rengo@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science/MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chiba University Hospital
Address 1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba 260-8670, Japan
Tel 043-222-7171
Email prc-jim@chiba-u.jp

Secondary IDs
Secondary IDs YES
Study ID_1 G2020015
Org. issuing International ID_1 Chiba University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 17 Day
Date of IRB
2020 Year 06 Month 17 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 04 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047162

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.