UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035770 |
|---|---|
| Receipt number | R000040288 |
| Scientific Title | Development and evaluation of a learning program for improvement in communication among family members |
| Date of disclosure of the study information | 2019/02/04 |
| Last modified on | 2020/02/12 08:32:30 |
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Basic information
Public title
Development and evaluation of a learning program for improvement in communication among family members
Acronym
Family learning program
Scientific Title
Development and evaluation of a learning program for improvement in communication among family members
Scientific Title:Acronym
Family learning program
Region
| Japan |
Condition
Condition
mental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research aims to develop a learning program to improve in communication among parents and their children with mental disorders, to prevent family violence, and to enable their higher QOL.
Basic objectives2
Others
Basic objectives -Others
QOL
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
expressed emotion
Key secondary outcomes
Experience of family violence within three months, psychological distress, family empowerment, and hope
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) Video viewing of the program, 2) small group discussion (90 minutes of 1 and 2), and 3) follow up by e-mail newsletters. These intervention period is three months.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parents living with their children with schizophrenia or persons with mental disorders.
Key exclusion criteria
nothing
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masako Kageyama |
Organization
Osaka University Graduate School of Medicine
Division name
Division of Health Sciences
Zip code
Address
Yamadaoka 1-7, Suita, Osaka, 565-0871
TEL
06-6879-2553
kageyama@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masako Kageyama |
Organization
Osaka University Graduate School of Medicine
Division name
Division of Health Sciences
Zip code
Address
Yamadaoka 1-7, Suita, Osaka, 565-0871
TEL
06-6879-2553
Homepage URL
kageyama@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Health Promotion Science, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
埼玉県精神障害者家族会連合会、横浜市精神障害者家族会連合会、YPS横浜ピアスタッフ協会
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s11126-020-09717-6
Number of participants that the trial has enrolled
71
Results
The average frequency of acts of family violence significantly decreased from 11.4 (SD = 26.2) at pretest to 5.1 (SD = 13.2) at posttest (p =0.016). Our findings showed significant improvements regarding expressed emotion, psychological distress, family empowerment, and hope.
Results date posted
| 2020 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 21 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 04 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040288
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
