UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063564 |
|---|---|
| Receipt number | R000072547 |
| Scientific Title | Effects of Behavioral Activation Therapy on Depression in Children with Neurodevelopmental Disorders and Subthreshold Depression: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/11/09 |
| Last modified on | 2026/11/09 10:15:12 |
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Basic information
Public title
Effects of Behavioral Activation Therapy on Depression in Children with Neurodevelopmental Disorders and Subthreshold Depression: A Pilot Randomized Controlled Trial
Acronym
Effects of Behavioral Activation Therapy on Depression in Children with Neurodevelopmental Disorders and Subthreshold Depression: A Pilot Randomized Controlled Trial
Scientific Title
Effects of Behavioral Activation Therapy on Depression in Children with Neurodevelopmental Disorders and Subthreshold Depression: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Effects of Behavioral Activation Therapy on Depression in Children with Neurodevelopmental Disorders and Subthreshold Depression: A Pilot Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Children with Neurodevelopmental Disorders and Subthreshold Depression
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the preliminary efficacy and feasibility of a behavioral activation intervention based on The Brief Behavioral Activation Treatment for Depression: Revised for children with neurodevelopmental disorders and subthreshold depression, focusing on its effects on depressive symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this trial is the mean change in Depression Self-Rating Scale for Children scores from baseline to the end of the planned intervention (Week 5).
Key secondary outcomes
The secondary outcomes are the mean changes in Child Behavior Check List, The New Stroop Test I, and Comprehensive Stress Response Inventory for Children scores from baseline to the end of the intervention (Week 5).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group will participate in five 45-minute The Brief Behavioral Activation Treatment for Depression: Revised sessions, held once a week for five weeks.
Interventions/Control_2
The control group will receive standard support at their usual after-school day service during the 5-week intervention period. They will not receive the Brief Behavioral Activation Treatment for Depression: Revised program as the study intervention.
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
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The selection criteria will be as follows: children aged 8 to 18 years who have been diagnosed with a neurodevelopmental disorder have a total score of at least 15 points on the Depression Self-Rating Scale for Children ; are able to understand and complete Depression Self-Rating Scale for Children; and use after-school day services at least once a week. The participants will be required to have sufficient cognitive ability to understand the content and purpose of the study and to provide informed consent. Written informed consent will be obtained from their parents or legal guardians prior to participation in the study.
Key exclusion criteria
The exclusion criteria will be as follows: children with a history of mental disorders other than neurodevelopmental disorders; children who are assessed as having a major depressive episode using the Mini-International Neuropsychiatric Interview for Children and Adolescents; children who are currently receiving specialized treatment for mental health problems; and children with visual or hearing impairments that interfere with daily living.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tsuchiya |
Organization
Nagano University of Health and Medicine
Division name
Graduate School of Health Sciences
Zip code
381-2227
Address
11-1 Imaihara, Kawanakajima-machi, Nagano-shi, Nagano, 381-2227, Japan
TEL
0262836111
tsuchiya.kenji@shitoku.ac.jp
Public contact
Name of contact person
| 1st name | Akiya |
| Middle name | |
| Last name | Uchida |
Organization
Nagano University of Health and Medicine
Division name
Graduate School of Health Sciences
Zip code
381-2227
Address
11-1 Imaihara, Kawanakajima-machi, Nagano-shi, Nagano, 381-2227, Japan
TEL
08037121916
Homepage URL
akiyas.593@gmail.com
Sponsor or person
Institute
Nagano University of Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagano University of Health and Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee, Nagano University of Health and Medicine
Address
11-1 Imaihara, Kawanakajima-machi, Nagano-shi, Nagano, 381-2227, Japan
Tel
026-283-6111
graduateshitoku@shitoku.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 11 | Month | 09 | Day |
Last modified on
| 2026 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072547
