UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009892 |
|---|---|
| Receipt number | 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 21:16:43 |
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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
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
tachibana-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011591
