UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059124 |
|---|---|
| Receipt number | R000067635 |
| Scientific Title | Evaluating the effectiveness of support program for parents |
| Date of disclosure of the study information | 2025/09/19 |
| Last modified on | 2025/09/18 17:07:14 |
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Basic information
Public title
Evaluating the effectiveness of support program for parents
Acronym
Effectiveness of support program for parents
Scientific Title
Evaluating the effectiveness of support program for parents
Scientific Title:Acronym
Effectiveness of support program for parents
Region
| Japan |
Condition
Condition
Parents
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement the support program for parents and evaluate its effectiveness as an indicator of improvement in parental mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Health Questionnaire-9 (PHQ-9) (9 items)
Key secondary outcomes
Positive and negative parenting scale (PNPS) (24 items)
Parenting self-efficacy scale (PSE) (14 items)
Strength and difficulties questionnaire (SDQ) (24 items)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A support program for parents consists of six 90-minute sessions, forming one course. The sessions are held at two-week intervals.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who understand the purpose of the study and agree to participate in the study.
Native speakers of Japanese and those who can fill in the questionnaire.
Key exclusion criteria
N/A.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Okumura |
Organization
Hamamatsu University School of Medicine
Division name
Research Center for Child Mental Development
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Japan
TEL
053-435-2331
okumura@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Okumura |
Organization
Hamamatsu University School of Medicine
Division name
Research Center for Child Mental Development
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Japan
TEL
053-435-2331
Homepage URL
okumura@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Akemi Okumura
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Japan
Tel
053-435-2331
okumura@hama-med.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
| 2025 | Year | 09 | 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
| 2025 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067635
