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

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 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


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

Value
https://center6.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