An assessor-blinded randomized controlled trial evaluating efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children

An assessor-blinded randomized controlled trial evaluating efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children - A randomized controlled trial of the Unified Protocol in children with emotional disorders

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037803

Enrollment

Registered

2019-08-26

Start date

2019-08-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, Separation Anxiety Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Clinical Global Impression-Severity (CGI-S) [Time Frame: 19weeks]	—

Secondary

Measure	Time frame
(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)	—

Measure

Time frame

(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)

—

Countries

Japan

Contacts

Public ContactHiroko Fujisato

National Center of Neurology and Psychiatry Department of Preventive Intervention for Psychiatric Disorders, National Institute of Mental Health

hfujisato@ncnp.go.jp042-341-2711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026