UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044285 |
|---|---|
| Receipt number | R000046396 |
| Scientific Title | Evaluation of effectiveness in behavioral parenting intervention through videoconferencing delivery format |
| Date of disclosure of the study information | 2021/06/10 |
| Last modified on | 2021/05/21 16:17:40 |
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Basic information
Public title
Evaluation of parenting support program Triple P through zoom
Acronym
Evaluation of Triple P through zoom
Scientific Title
Evaluation of effectiveness in behavioral parenting intervention through videoconferencing delivery format
Scientific Title:Acronym
Effectiveness of parenting intervention through telehealth
Region
| Japan |
Condition
Condition
Behavior problem of children
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To deliver behavioral parenting program to those parents who have trouble with behavior fo children and evaluate the effectiveness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
within one week after intervention
Parenting scale
Strength and difficulty questionnaire
Depression, anxiety and stress score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Level 4 group Triple P
Behavioral intervention for eight weeks. Five times group works for two hours and three times telephone session for 30 minutes.
Interventions/Control_2
No intervention
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
Intervention group: parents whose children have behavioral difficulties who are recruited from fliers or websites
Control group: community panel parents who have some trouble with behavior of children
Key exclusion criteria
do not read and write Japanese
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Kato |
Organization
Jumonji University
Division name
Department of Early Childhood Care and Education
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza,Saitama
TEL
048-423-0124
n-katou@jumonji-u.ac.jp
Public contact
Name of contact person
| 1st name | Isoko |
| Middle name | |
| Last name | Morita |
Organization
Specified non-profit organization Triple P Japan
Division name
Secretariat
Zip code
140-0014
Address
3F Agora 1-6-3 Ooi, Shonagawa-ku, Tokyo
TEL
03-3777-2722
Homepage URL
office@triplep-japan.org
Sponsor or person
Institute
Department of Early Childhood Care and Education, Jumonji University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Jumonji University
Address
2-1-28 Sugasawa, Niiza, Saitama 352-8510 Japan
Tel
048-477-0555
k-kenkyu@jumonji-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
| 2021 | Year | 06 | Month | 10 | 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
36
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
Completed
Date of protocol fixation
| 2000 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046396
