UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A psychoeducational intervention program for children with inflammatory bowel disease: a pilot randomized controlled trial
Title of the study (Brief title)	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	Yoshiyuki Tachibana
Organization	National Center for Child Health and Development
Division name	Division of Maternal-Child Psychiatry, Department of Psychosocial Medicine
Address	2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL	81-(0)3-3416-0181
Email

Public contact
Name of contact person	Yoshiyuki Tachibana
Organization	National Center for Child Health and Development
Division name	Division of Maternal-Child Psychiatry, Department of Psychosocial Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 08 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011591