UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063252 |
|---|---|
| Receipt number | R000072398 |
| Scientific Title | Effectiveness of the TOP Program (Treasure Is Outdoor Play Program): A Controlled Trial Comparing Children With and Without Developmental Characteristics |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/13 11:38:34 |
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Basic information
Public title
TOP Program Treasure Is Outdoor Play Program An Outdoor Play Based Parent and Child Mental Health Program for Elementary School Children and Their Parents
Acronym
Tresure is Outdoor play Program
Scientific Title
Effectiveness of the TOP Program (Treasure Is Outdoor Play Program): A Controlled Trial Comparing Children With and Without Developmental Characteristics
Scientific Title:Acronym
TOP-P Study
Region
| Japan |
Condition
Condition
developmental characteristics
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of the TOP Program, a parent and child mental health program that combines outdoor play and psychoeducational videos for elementary school children and their parents. The program is designed to support children's emotional regulation, communication skills, and overall strengths, while enhancing parents' understanding of developmental characteristics and their coping skills for parenting-related stress. Children with and without developmental characteristics will participate in the same program, and the study will compare the effectiveness of the program and any differences in outcomes between these groups. The program aims to promote and maintain the mental wellbeing of both children and their parents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Strengths and Difficulties Questionnaire, Parent Version (SDQ-P)
Salivary Cortisol
Key secondary outcomes
Cognitive Function Questionnaire (Open-Ended Questionnaire)
General Self-Efficacy Scale (GSES)
Parenting Resilience Elements Questionnaire (PREQ)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group will receive a two-week intervention consisting of: (1) viewing online psychoeducational videos, (2) participating in an outdoor play program conducted on a weekend at the study site under the supervision of researchers and local collaborators, and (3) engaging in parent-child outdoor play activities at home for two weeks. During the intervention period, children will wear a wearable device to collect physiological data, including heart rate and sleep patterns. In addition to questionnaire assessments, salivary cortisol will be measured as a stress-related biomarker. Following completion of the program, a psychologist will conduct a semi-structured interview. Assessments will be conducted immediately after the intervention and again at 1-month and 3-month follow-up points.
Interventions/Control_2
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children with Developmental Characteristics
Children who have been diagnosed with Autism Spectrum Disorder (ASD) or Attention-Deficit/Hyperactivity Disorder (ADHD) by a physician.
Children who score at or above the cutoff value on the Autism-Spectrum Quotient (AQ) (20 points or higher) and/or at or above the cutoff value on the ADHD Rating Scale (ADHD-RS, Child Version).
(Children meeting either one or both of the above criteria will be included in this group.)
Children without Developmental Characteristics
Children who have not been diagnosed with ASD or ADHD by a physician.
Children who score below the cutoff value on the AQ (less than 20 points) and below the cutoff value on the ADHD Rating Scale (ADHD-RS, Child Version).
Children who score below the cutoff value on the AQ (<20 points) and below the cutoff value on the ADHD-RS (Child Version).
Key exclusion criteria
Individuals for whom informed consent cannot be obtained after receiving a full explanation of the study, or whose parent/legal guardian refuses the use of their information for research purposes.
Individuals with severe physical or psychiatric disorders that would prevent them from completing the study questionnaires.
Individuals who have been instructed by a physician to restrict physical activity, or those with an acute illness, serious medical history, or other conditions that the Principal Investigator considers unsuitable for participation in the study.
Individuals deemed inappropriate for participation in the study for any other reason at the discretion of the researchers.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | MIYUKI |
| Middle name | |
| Last name | FURUKAWA |
Organization
Chiba University
Division name
Research Center for Child Mental Development and Education
Zip code
260-8670
Address
Inohana, Chuo ku,Chiba shi, Chiba 260 8672,Japan
TEL
0432262027
n.furukawa@chiba-u.jp
Public contact
Name of contact person
| 1st name | MIYUKI |
| Middle name | |
| Last name | FURUKAWA |
Organization
Chiba University
Division name
Research Center for Child Mental Development and Education
Zip code
260-8670
Address
Inohana, Chuo ku,Chiba shi, Chiba 260 8672,Japan
TEL
09098514825
Homepage URL
https://www.cocoro.chiba-u.jp/recruit/top./
m.furukawa@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
Inohana, Chuo ku,Chiba shi, Chiba 260 8672,Japan
Tel
043-222-7171
inohana-rinri@chiba-u.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 | 10 | Month | 13 | 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 | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 30 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072398
