UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027232 |
|---|---|
| Receipt number | 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 | 2020/11/04 10:41:13 |
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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
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
hiromitobe-tky@umin.ac.jp
Sponsor or person
Institute
Department of Family Nursing
School of Health Sciences and Nursing
Graduate School of Medicine
The University of Tokyo
Institute
Department
Personal name
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
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
| 2020 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031158
