Unique ID issued by UMIN | UMIN000026911 |
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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 |
feasibility study of the unified protocol for children with emotional disorders
open label study of the unified protocol for children with emotional disorders
feasibility study of the unified protocol for children with emotional disorders
open label study of the unified protocol for children with emotional disorders
Japan |
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
Psychiatry | Child |
Others
NO
This study will examine the feasibility and potential efficacy of the unified protocol for children with emotional disorders.
Safety,Efficacy
clinical global impression-severity (CGI-S) [Time Frame: 16 weeks]
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Behavior,custom |
cognitive behavioral therapy (unified protocol)
8 | years-old | <= |
12 | years-old | >= |
Male and Female
(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.
(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.
18
1st name | Masaru |
Middle name | |
Last name | Horikoshi |
National Center of Neurology and Psychiatry
National Center for Cognitive Behavior Therapy and Research
187-8551
Ogawahigashicho 4-1-1, Kodaira-shi, Tokyo, Japan
042-341-2711
mhorikoshi@ncnp.go.jp
1st name | Hiroko |
Middle name | |
Last name | Fujisato |
National Center of Neurology and Psychiatry
Department of Preventive Intervention for Psychiatric Disorders, National Institute of Mental Health
187-8551
Ogawahigashicho 4-1-1, Kodaira-shi, Tokyo, Japan
042-341-2711
hfujisato@ncnp.go.jp
National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
Japan Society for the Promotion of Science
Japanese Governmental office
Department of Child and Adolescent Psychiatry, Kohnodai Hospital, National Center for Global Health and Medicine
Institutional Review Board, National Center of Neurology and Psychiatry
Ogawahigashicho 4-1-1, Kodaira-shi, Tokyo, Japan
042-341-2711
ml_rinrijimu@ncnp.go.jp
NO
国立国際医療センター 国府台病院 児童精神科(千葉県)
2017 | Year | 04 | Month | 08 | Day |
Unpublished
17
Completed
2016 | Year | 10 | Month | 07 | Day |
2016 | Year | 10 | Month | 07 | Day |
2017 | Year | 04 | Month | 08 | Day |
2018 | Year | 10 | Month | 05 | Day |
2017 | Year | 04 | Month | 08 | Day |
2019 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030860
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