UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009892
Receipt No. R000011591
Scientific Title A psychoeducational intervention program for children with inflammatory bowel disease: a pilot randomized controlled trial
Date of disclosure of the study information 2013/01/29
Last modified on 2019/02/03

* 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 A psychoeducational intervention program for children with inflammatory bowel disease: a pilot randomized controlled trial
Acronym A pilot RCT of a psychoeducation program for children with IBD
Scientific Title A psychoeducational intervention program for children with inflammatory bowel disease: a pilot randomized controlled trial
Scientific Title:Acronym A pilot RCT of a psychoeducation program for children with IBD
Region
Japan

Condition
Condition Inflammatory Bowel Disease
Classification by specialty
Medicine in general Gastroenterology Psychiatry
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study invesitigates the effectiveness of an psychoeducation intervention program using cognitive behavior therapy for children with inflammatory bowel disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total score of the Children's Depression Inventory
Key secondary outcomes Total score of the IMACAT-3
Total score of the Pediatric Symptom Checklist

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 A psychoeducational intervention program based on cognitive behavior therapy
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
9 years-old <=
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria Children who are diagnosed as inflammatory bowel disease, and are treated at the outpatient clinic of the department of gastrointestinal medicine of the National Center for Child Health and Development in Japan.
Key exclusion criteria 1. Children who have other severe diseases and have been treated for them.
2. Children who have been treated with a psychotherapy.
3. Children who have learning disabilities or mental retardation which cause them not to be able to perform this intervention program.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Tachibana
Organization National Center for Child Health and Development
Division name Division of Maternal-Child Psychiatry, Department of Psychosocial Medicine
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL 81-(0)3-3416-0181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Tachibana
Organization National Center for Child Health and Development
Division name Division of Maternal-Child Psychiatry, Department of Psychosocial Medicine
Zip code
Address
TEL
Homepage URL
Email tachibana-y@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization National Center for Child Health and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2013 Year 01 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2012 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 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
2013 Year 01 Month 29 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011591

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.