UMIN-CTR Clinical Trial

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
Email	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
Email	office@triplep-japan.org

Sponsor
Institute	Department of Early Childhood Care and Education, Jumonji University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046396