UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026911
Receipt number 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 09:41:54

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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