UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050803 |
|---|---|
| Receipt number | R000057894 |
| Scientific Title | Intervention Studies to Improve Children's Social-Emotional Skills |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/10 16:39:26 |
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Basic information
Public title
Intervention Studies to Improve Children's Social-Emotional Skills
Acronym
Intervention Studies to Improve Children's Social-Emotional Skills
Scientific Title
Intervention Studies to Improve Children's Social-Emotional Skills
Scientific Title:Acronym
Intervention Studies to Improve Children's Social-Emotional Skills
Region
| Japan |
Condition
Condition
Children's Social-Emotional Skills
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Social-emotional skills such as perseverance, social skills, and self-esteem, rather than cognitive skills such as so-called language and math skills, are important for children to benefit from the opportunities that the challenges of the 21st century will bring and to succeed in the future. Caregivers can help children develop these skills by improving the learning environment in which they are developed. There is evidence that families, schools, and communities have an important role to play in promoting children's social-emotional skills and that coherence among multiple learning environments needs to be ensured. An important part of fostering social-emotional skills is listening to the child's voice. It is known that listening to the child's voice increases the child's own sense of security, self-affirmation, and sense of attachment (safe base), motivates them to engage in exploratory behaviors, and improves the quality of the interactions of the adults involved. This study will conduct an intervention study by conducting a "child-care time: 3-minute listen" by parents. 3-minute listen will be conducted by a parent or caregiver. Before listening, the parent or caregiver teaches the child that this is a time when he or she is free to talk about anything, that he or she is not to deny anything that is said, not to ask why, and to listen without giving his or her opinion, in order to ensure the child's psychological safety. Let the child speak freely about whatever he/she wants to talk about, and listen to the end without interrupting as much as possible. Conclude by thanking them for their talk. Ask the child to put a sticker on the card when he or she has had three minutes of parent-child dialogue. The program will be conducted at least once a week for three months, and every month, we will collect examples of how children's voices were successfully heard and points to be improved, and share them with the research participants.
Basic objectives2
Others
Basic objectives -Others
An information session will be held at a parent-teacher conference at a kindergarten attached to the Faculty of Education of Mie University in July 2023, and those who wish to participate in the intervention will be recruited and designated as the intervention group. Those who did not wish to participate in the intervention will be the control group. The target population consists of three kindergarten grades (3 to 6 years old), with approximately 20 children per grade. The study design is shown in Figure 2. The DESSA-mini (Devereux Student Strengths Assessment) will be administered by homeroom teachers to all students (intervention and control group) prior to the intervention (July) as a baseline survey. Participants will participate in a 3-minute listen intervention at least once a week for 3 months starting in August 2023.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An information session will be held at a parent-teacher conference at a kindergarten attached to the Faculty of Education of Mie University in July 2023 to recruit potential participants who can provide the intervention (referred to as the intervention group). Those who agree to the study but did not wish to participate in the intervention will be the control group. The target population includes three grades (ages 3-6), with approximately 20 preschoolers per grade. The DESSA-mini, a standardized questionnaire measuring social-emotional skills, will be administered by homeroom teachers to all participants who are eligible for the intervention (intervention group) and non-participants (control group) as a baseline survey (July). Devereux Student Strengths Assessment) is a scale to assess social-emotional skills of children between the ages of 5 and 13. It assesses non-cognitive skills by looking at the positive aspects and strengths of children rather than their problem behaviors. Respondent homeroom teachers must have been in contact with the target children for at least 4 weeks. 3-month participants will receive a 3-minute listen intervention beginning in August 2023. As a follow-up, in November after the intervention, homeroom teachers will administer the DESSA-mini assessment to all participants and non-participants who participated in the intervention. At this point, the homeroom teachers are blinded to the identity of the participants. After the intervention, a parent questionnaire about the parenting environment will be administered to both intervention and non-intervention participants. Changes in DESSA-mini will be compared between intervention participants (intervention group) and non-participants (target group). Free-response statements about how they hear their child's voice will also be compared between participants and non-participants.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Beginning in August 2023, 3-month participants will receive a 3-minute listen intervention.
Interventions/Control_2
Those who did not wish to participate in the intervention will be the control group
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
| 3 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
An information session will be held at a parent-teacher conference at a kindergarten attached to the Faculty of Education of Mie University in July 2023, and those who wish to participate in the intervention will be recruited and designated as the intervention group. Those who did not wish to participate in the intervention will be the control group. The target population consisted of three kindergarten grades (3 to 6 years old), with approximately 20 children per grade.
Key exclusion criteria
Not set in particular.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Fujiwara |
Organization
Tokyo Medical and Dental University
Division name
Globa Health Promotion
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5187
fujiwara.hlth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Fujiwara |
Organization
Tokyo Medical and Dental University
Division name
Global Health Promotion
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5187
Homepage URL
fujiwara.hlth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental university, operating expenses
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo M&D Tower 16F South
Tel
03-3813-6111
syomu1.adn@tmd.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
| 2023 | Year | 05 | Month | 01 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | 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
| 2023 | Year | 04 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057894
