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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000027232
Receipt No. R000031158
Scientific Title The efficacy of resilience enhancing program for parents focused on the emotion of anger: Randomized controlled trial
Date of disclosure of the study information 2017/05/03
Last modified on 2019/05/06

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Basic information
Public title The efficacy of resilience enhancing program for parents focused on the emotion of anger: Randomized controlled trial
Acronym The efficacy of resilience enhancing program for parents focused on the emotion of anger: Randomized controlled trial
Scientific Title The efficacy of resilience enhancing program for parents focused on the emotion of anger: Randomized controlled trial
Scientific Title:Acronym The efficacy of resilience enhancing program for parents focused on the emotion of anger: Randomized controlled trial
Region
Japan

Condition
Condition Anger
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of the resilience enhancing program for parents focused on the emotion of anger
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes STAXI(State-Trait Anger Expression Inventory)Anger-Out Anger-In Anger-Control
Pre/Post intervention /Two-month follow-up
Key secondary outcomes Cognition on Children's Behavior Inventory
Communication Attitude in Marriage Inventory
Pre/Post intervention /Two-month follow-up

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Intervention group
1.Mothers in intervention group participate in two-hour group program four times every other week.
2.Content of the program: 1st session: Elements to enhance resilience, emotion management, 2nd session: Strengthening the relationship with children, 3rd session: Strengthening the relationship with spouse, 4th session: Improving self-esteem
3.Each group consists of 6 to 14 mothers and group discussion, role-play and workshop are led by a facilitator.

Mothers and fathers answer the questionnaire at pre/post intervention and two-month follow-up.
Interventions/Control_2 Control group
1.Mothers in control group participate in two-hour tea party four times every other week.
2.Content of the tea party: In each session, participants freely discuss their daily stress and their coping strategy
3.Each group consists of 6 to 14 mothers and group discussion is led by a group leader.

Mothers and fathers answer the questionnaire at pre/post intervention and two-month follow-up.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Parents who have a child/children between the age of three to six
2.Healthy adult older than 18 years old
Key exclusion criteria 1.Those who don't understand Japanese
2.Those who have mental illness
Target sample size 280

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Tobe
Organization The University of Tokyo
Graduate School of Medicine
School of Health Sciences and Nursing
Division name Department of Family Nursing
Zip code 113-0033
Address 7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan
TEL 03-5841-3694
Email hiromitobe-tky@umin.ac.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Tobe
Organization The University of Tokyo Graduate School of Medicine School of Health Sciences and Nursing
Division name Department of Family Nursing
Zip code 113-0033
Address 7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan
TEL 03-5841-3399
Homepage URL
Email hiromitobe-tky@umin.ac.jp

Sponsor
Institute Department of Family Nursing
School of Health Sciences and Nursing
Graduate School of Medicine
The University of Tokyo
Institute
Department

Funding Source
Organization Gushinkai Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dapartment of Family Nursing
Address 7-3-1, Hongo, Bunkyo, Tokyo, Japan
Tel 81-3-5841-4694
Email hiromitobe-tky@umin.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 東京大学大学院医学系研究科(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 03 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
Date of protocol fixation
2017 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 03 Day
Last modified on
2019 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031158

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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