UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038979
Receipt number R000044438
Scientific Title Research on evaluation of early intervention of parenting program for the adolescent mental health
Date of disclosure of the study information 2019/12/28
Last modified on 2020/06/25 11:33:27

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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 or person

Institute

School of Health and Nursing Science, Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044438


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name