UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062614 |
|---|---|
| Receipt number | R000071673 |
| Scientific Title | A Study of the Effectiveness of Home-Visiting Parenting Programs Offered Through the 3-Year-Old Child Health Checkup |
| Date of disclosure of the study information | 2026/08/19 |
| Last modified on | 2026/08/19 15:17:41 |
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Basic information
Public title
A Study of the Feasibility and Effectiveness of a Home-Visiting Parenting Support Program
Acronym
Home-Visiting Parenting Support Study
Scientific Title
A Study of the Effectiveness of Home-Visiting Parenting Programs Offered Through the 3-Year-Old Child Health Checkup
Scientific Title:Acronym
Home-Visiting Parenting Program RCT
Region
| Japan |
Condition
Condition
Parenting stress and parenting difficulties among parents of infants and preschool-aged children
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate, using an individually randomized controlled trial, whether home-visiting parenting programs offered through the 3-year-old child health checkup reduce parenting stress and parenting difficulties. Based on each family's support needs, participating families receive one of the following parenting programs: CARE, SafeCare, Watch Me Play!, or Triple P. Outcomes are compared with those of the control group. The study also examines acceptability, ease of participation and continuation, participant burden, and conditions relevant to implementing the programs in community-based parenting support services.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Parenting stress assessed using the total score of the Parenting Stress Index-Short Form (PSI-SF) at the post-intervention assessment. Post-intervention PSI-SF total scores are compared between the intervention and control groups, taking baseline PSI-SF total scores into account.
Key secondary outcomes
1. PSI-SF total score at the post-intervention and follow-up assessments
2. Center for Epidemiologic Studies Depression Scale (CES-D) score at the post-intervention and follow-up assessments
3. PNPS score among age-eligible participants at the post-intervention and follow-up assessments
4. Acceptability, ease of participation and continuation, perceived benefits, burden, and areas for improvement assessed through interviews with parents
5. Facilitators, barriers, burden, and areas for improvement in program delivery assessed through interviews with home visitors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Based on each family's support needs, one of the following home-visiting parenting programs is provided: CARE, SafeCare, Watch Me Play!, or Triple P. The program is delivered by a trained home visitor. Each session lasts approximately 60 minutes, with a total of 5 to 10 sessions.
Interventions/Control_2
Wait-list control group: Families do not receive the study-provided home-visiting parenting program during the 12-week period after T0 but may continue to use usual municipal, medical, and welfare services. After completing the T1 assessment at 12 weeks after T0, families are offered the parenting program selected according to their support needs.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Families are eligible if all of the following criteria are met:
The family resides in Koganei City.
The questionnaire respondent is the child's father or mother and is aged 18 years or older at the time informed consent is obtained.
The target child is between birth and entry into elementary school at the time informed consent is obtained.
If there is more than one child in the family, the parent is able to identify one child as the target child whom they primarily wish to discuss and support through the program.
The questionnaire respondent is able to understand the study information provided in Japanese and provide written informed consent to participate.
The questionnaire respondent is able to complete the questionnaires and interviews in Japanese.
The family is able to receive the parenting program through face-to-face home visits.
Key exclusion criteria
Families are excluded if any of the following criteria apply:
At the time of study enrollment, staff members of the Child and Family Center and the principal investigator determine that urgent administrative, medical, psychological, or social welfare support should take priority over research participation.
The family has previously received or is currently receiving any of the following programs: CARE, SafeCare, Level 3 Primary Care Triple P, or Watch Me Play!
Staff members of the Child and Family Center and the principal investigator determine that face-to-face home visits cannot be conducted while ensuring the safety of the participant and the home visitor.
The principal investigator determines that participation is inappropriate because the assessments or intervention specified in the study protocol cannot reasonably be conducted.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Minako |
| Middle name | |
| Last name | Iwasaki |
Organization
Tokyo Gakugei University
Division name
Department of Educational Psychology, Faculty of Education
Zip code
184-8501
Address
4-1-1 Nukuikita-machi, Koganei-shi Tokyo
TEL
+81-42-329-7373
miwasaki@u-gakugei.ac.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Iwasaki |
Organization
Tokyo Gakugei University
Division name
Department of Educational Psychology, Faculty of Education
Zip code
184-8501
Address
4-1-1 Nukuikita-machi, Koganei-shi Tokyo
TEL
+81-42-329-7373
Homepage URL
miwasaki@u-gakugei.ac.jp
Sponsor or person
Institute
Tokyo Gakugei University
Institute
Department
Personal name
Funding Source
Organization
Koganei City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Gakugei University Research Ethics Committee
Address
4-1-1 Nukuikita-machi, Koganei-shi, Tokyo
Tel
+81-42-329-7228
kyoken@u-gakugei.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 | 08 | Month | 19 | 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
| 2026 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 09 | 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
This trial was registered in the UMIN Clinical Trials Registry after participant enrollment had begun. By the time of registration, five families had provided informed consent to participate in the study. Any new baseline assessments (T0), randomization, allocation-specific interventions, and T1 outcome assessments will be conducted after registration in the UMIN Clinical Trials Registry. A change to the scientific study title is currently under ethical review. Following approval, the scientific title in the registry will be updated with the amendment documented in the registration history.
Management information
Registered date
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071673
