UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056548 |
|---|---|
| Receipt number | R000064620 |
| Scientific Title | Study of early intervention for young children with possible developmental problems based on child-raising psychology program |
| Date of disclosure of the study information | 2024/12/24 |
| Last modified on | 2025/05/07 11:15:08 |
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Basic information
Public title
Study of early intervention for young children based on child-raising psychology program
Acronym
Study of early intervention for young children based on child-raising psychology program
Scientific Title
Study of early intervention for young children with possible developmental problems based on child-raising psychology program
Scientific Title:Acronym
Study of early intervention for young children with possible developmental problems based on child-raising psychology program
Region
| Japan |
Condition
Condition
Developmental disorders, Mental retardation, Premature delivery, Child abuse
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of child-raising psychology program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in caregivers' cognition of child-raising and changes in their child-raising behavior (improvement of child-raising skills, reduction of inappropriate child-raising, improvement of cognition of child-raising behavior and relationships, increased acceptance of responsibility for child-raising) and changes in child behavior (mothers' evaluation of reduction of child's problematic behavior)
Key secondary outcomes
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of child-raising psychology program with real toys face to face
Interventions/Control_2
Implementation of child-raising psychology program with real toys through internet
Interventions/Control_3
Implementation of child-raising psychology program with digital toys through internet
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
| 16 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
eople who meet all of the following criteria.
(1) If the applicant agrees to participate in the child-raising psychology program (including pre- and post-surveys)
(2) Able to communicate adequately in Japanese and have no difficulty in decision-making
(3) Raising a child between 1.5 and 7 years of age
Key exclusion criteria
People who meet at least one of the following criteria
(1)Experienced a serious life event (death of a close relative, serious illness, or other extremely stressful event) within six months of the time of the preliminary survey
(2)If the researcher deems the participant ineligible for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Ohta |
Organization
Akita University Graduate School of Medicine
Division name
Department of Occupational Therapy
Zip code
010-8543
Address
Hondo 1-1-1, Akita, Akita 010-8543, Japan
TEL
018-884-6540
hideohta@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenobu |
| Middle name | |
| Last name | Ohta |
Organization
Akita University Graduate School of Medicine
Division name
Department of Occupational Therapy
Zip code
010-8543
Address
Hondo 1-1-1, Akita, Akita 010-8543, Japan
TEL
018-884-6540
Homepage URL
hideohta@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Akita University Graduate School of Medicine and Faculty of Medicine
Address
Hondo 1-1-1, Akita, Akita 010-8543, Japan
Tel
018-884-6028
soken@hos.akita-u.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
| 2024 | Year | 12 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2034 | 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
| 2024 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064620
