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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026911
Receipt No. R000030860
Scientific Title feasibility study of the unified protocol for children with emotional disorders
Date of disclosure of the study information 2017/04/08
Last modified on 2019/04/10

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Basic information
Public title feasibility study of the unified protocol for children with emotional disorders
Acronym open label study of the unified protocol for children with emotional disorders
Scientific Title feasibility study of the unified protocol for children with emotional disorders
Scientific Title:Acronym open label study of the unified protocol for children with emotional disorders
Region
Japan

Condition
Condition major depressive disorder, persistent depressive disorder, unspecified depressive disorder, separation anxiety disorder, specific phobia, social anxiety disorder, panic disorder, agoraphobia, generalized anxiety disorder, unspecified anxiety disorder, obsessive-compulsive disorder
Classification by specialty
Psychiatry Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will examine the feasibility and potential efficacy of the unified protocol for children with emotional disorders.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clinical global impression-severity (CGI-S) [Time Frame: 16 weeks]
Key secondary outcomes 1. children's severity of anxiety (Spence children's anxiety scale, Spence children's anxiety scale for parents)
2. children's severity of depression (depression self-rating scale for children, depression parent-rating scale)
3. children's function (the sense of emotional well-being scale, pediatric symptom checklist, child outcome rating scale, child outcome rating scale for parents)
4. adverse event

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 cognitive behavioral therapy (unified protocol)
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
8 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria (a) child with principal diagnosis of DSM-5 major depressive disorder, persistent depressive disorder, unspecified depressive disorder, separation anxiety disorder, specific phobia, social anxiety disorder, panic disorder, agoraphobia, generalized anxiety disorder, unspecified anxiety disorder, obsessive-compulsive disorder.
(b) child's clinical global impression-severity >= 4 at baseline.
(c) child is third-grade to sixth-grade at baseline.
(d) child and parent give full consent in the participation of the study.
Key exclusion criteria (a) child with DSM-5 diagnosis of manic episode, hypomanic episode, or psychotic disorders at baseline.
(b) child with serious suicidal ideation at baseline.
(c) child receiving other structured psychotherapy at baseline or planning to receive it during the intervention.
(d) child or parent with severe intellectual disabilities or learning disorders to interfere with the understanding of the question or treatment material.
(e) child or parent is assured to absent from at least 5 of 15 sessions.
(f) parent has physical, mental, or cognitive disorders to make him/her difficult to support his/her child.
(g) child has some problematic behaviors to interfere with the implementation of the group.
(h) other relevant reason decided by the investigators.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Masaru
Middle name
Last name Horikoshi
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Zip code 187-8551
Address Ogawahigashicho 4-1-1, Kodaira-shi, Tokyo, Japan
TEL 042-341-2711
Email mhorikoshi@ncnp.go.jp

Public contact
Name of contact person
1st name Hiroko
Middle name
Last name Fujisato
Organization National Center of Neurology and Psychiatry
Division name Department of Preventive Intervention for Psychiatric Disorders, National Institute of Mental Health
Zip code 187-8551
Address Ogawahigashicho 4-1-1, Kodaira-shi, Tokyo, Japan
TEL 042-341-2711
Homepage URL
Email hfujisato@ncnp.go.jp

Sponsor
Institute National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
Institute
Department

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

Other related organizations
Co-sponsor Department of Child and Adolescent Psychiatry, Kohnodai Hospital, National Center for Global Health and Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board, National Center of Neurology and Psychiatry
Address Ogawahigashicho 4-1-1, Kodaira-shi, Tokyo, Japan
Tel 042-341-2711
Email ml_rinrijimu@ncnp.go.jp

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 国立国際医療センター 国府台病院 児童精神科(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 08 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 17
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 Completed
Date of protocol fixation
2016 Year 10 Month 07 Day
Date of IRB
2016 Year 10 Month 07 Day
Anticipated trial start date
2017 Year 04 Month 08 Day
Last follow-up date
2018 Year 10 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 08 Day
Last modified on
2019 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030860

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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