UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037803 |
|---|---|
| Receipt number | R000041555 |
| Scientific Title | An assessor-blinded randomized controlled trial evaluating efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2022/08/01 12:12:15 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041555
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