UMIN-CTR Clinical Trial

Basic information
Public title	An assessor-blinded randomized controlled trial evaluating efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children
Acronym	A randomized controlled trial of the Unified Protocol in children with emotional disorders
Scientific Title	An assessor-blinded randomized controlled trial evaluating efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children
Scientific Title:Acronym	A randomized controlled trial of the Unified Protocol in children with emotional disorders
Region	Japan

Condition
Condition	Major Depressive Disorder, Separation Anxiety Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the superiority of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) added to treatment as usual (TAU) in comparison with the waiting-list with TAU.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical Global Impression-Severity (CGI-S) [Time Frame: 19weeks]
Key secondary outcomes	(a) Clinical Global Impression-Improvement (CGI-I) (b) Severity of anxiety symptoms (Spence Children's Anxiety Scale, Spence Children's Anxiety Scale-Parent Report) (c) Severity of depressive symptoms (Children's Depression Inventory, Children's Depression Inventory-Parent Report) (d) Functional status (Child Outcome Rating Scale, Child Outcome Rating Scale-Parent Report) (e) Psychiatric diagnosis assessed by Mini International Neuropsychiatric Interview for children and adolescents (M.I.N.I-KID)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) with treatment as usual (TAU) UP-C is a transdiagnostic cognitive-behavioral therapy for emotional disorders, which was developed by Dr. Ehrenreich-May and her colleagues. UP-C is weekly, face to face, group psychotherapy consisting of 15 sessions. Most of the TAU will be psychoeducation, pharmacotherapy, and/or nonsystematic supportive psychotherapy.
Interventions/Control_2	Waitlist Control with treatment as usual During the waitlist period (21 weeks), the waitlist participants continue the TAU. Most of the TAU will be psychoeducation, pharmacotherapy, and/or nonsystematic supportive psychotherapy. They will receive the UP-C following the 21 weeks waiting period.
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, Separation Anxiety Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder assessed by M.I.N.I-KID. (b) Child's CGI-S is moderate or more severe at baseline (CGI-S >= 4). (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 is 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 questions or treatment materials. (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	84

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	Japan

Other related organizations
Co-sponsor	(a) Kohnodai Hospital, National Center for Global Health and Medicine (b) Iwate Medical University (c) Tokyo Metropolitan Children's Medical Center
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	(a) 国立国際医療センター 国府台病院（千葉県） (b) 岩手医科大学（岩手県） (c) 東京都立小児総合医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 26 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
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	Terminated
Date of protocol fixation	2019 Year 03 Month 27 Day
Date of IRB	2019 Year 03 Month 27 Day
Anticipated trial start date	2019 Year 08 Month 26 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 26 Day
Last modified on	2022 Year 08 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041555