UMIN-CTR Clinical Trial

Basic information
Public title	Research on evaluation of early intervention of parenting program for the adolescent mental health
Acronym	Study for the effect of Teen Triple P seminer
Scientific Title	Research on evaluation of early intervention of parenting program for the adolescent mental health
Scientific Title:Acronym	Study for the effect of Teen Triple P seminer
Region	Japan

Condition
Condition	Parents of 11 to 15 year-old child
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate of the parenting program effect for the parents of adolescent children.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Client Satisfaction Questionnaire
Key secondary outcomes	1.Immediately after intervention Parent status;Parenal style,Parent confidence of child-raising, Parent mental health 2.Afrer 6 weeks Child status;Child behavior Parent status;Parenal style,Parent confidence of child-raising, Parent mental health

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	parenting1 program for 90min
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	11 years-old <=
Age-upper limit	15 years-old >
Gender	Male and Female
Key inclusion criteria	parents who have the children aged from 11-15 years old.
Key exclusion criteria	parents who have the children as registerd "abused child or delinquent child"
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Toshihiko Middle name Last name Yanagawa
Organization	School of Health and Nursing Science, Wakayama Medical University
Division name	Division of Health and Nrsing Science
Zip code	6411-0011
Address	580 Mikazura, Wakayama, 641-0011, Japan
TEL	073-446-6700
Email	tyanagaw@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Toshihiko Middle name Last name Yanagawa
Organization	School of Health and Nursing Science, Wakayama Medical University
Division name	Division of Health and Nrsing Science
Zip code	6411-0011
Address	580 Mikazura, Wakayama, 641-0011, Japan
TEL	073-446-6700
Homepage URL
Email	tyanagaw@wakayama-med.ac.jp

Sponsor
Institute	School of Health and Nursing Science, Wakayama Medical University
Institute
Department

Funding Source
Organization	Ministry of Education
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	Clinical Reserch Center, Wakayama Medical University
Address	811-1 Kimiidera, Wakayama, 641-8509, Japan
Tel	073-447-2300
Email	wa-rinri@wakayama-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	和歌山県立医科大学保健看護学部（和歌山県）

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 28 Day

Related information
URL releasing protocol	Not disclose information other than what is described on this site
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	2019 Year 12 Month 24 Day
Date of IRB	2020 Year 01 Month 09 Day
Anticipated trial start date	2020 Year 01 Month 12 Day
Last follow-up date	2020 Year 12 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	2019 Year 12 Month 24 Day
Last modified on	2020 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044438