UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046743 |
|---|---|
| Receipt number | R000053303 |
| Scientific Title | Approach to Support Families of Alcoholics Using CRAFT: A Study on the Introduction of CRAFT Using active hearing |
| Date of disclosure of the study information | 2022/01/27 |
| Last modified on | 2023/01/30 17:31:32 |
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Basic information
Public title
Approach to Support Families of Alcoholics Using CRAFT: A Study on the Introduction of CRAFT Using active hearing
Acronym
Effects of CRAFT and active hearing in supporting families of alcoholics
Scientific Title
Approach to Support Families of Alcoholics Using CRAFT: A Study on the Introduction of CRAFT Using active hearing
Scientific Title:Acronym
Effects of CRAFT and active hearing in supporting families of alcoholics
Region
| Japan |
Condition
Condition
well-being
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effects of CRAFT on the families of alcoholics and the effects of active hearing during the introduction of CRAFT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Degree of depression: Beck Depression Rating Scale (BDI; Beck et al.,1988)
2.Degree of self-esteem: State Self-Esteem Scale (Heatherton & Polivy, 1991)
3.Anger: State Anger Manifestation Inventory (STAXI; Spielberger. 1988)
4.Anxiety: State Anxiety Inventory (STAI; Spielberger et ai., 1983)
5.Relationship Happiness: Relationship Happiness Scale (Azrin et al.,1973)
Key secondary outcomes
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
| Other |
Interventions/Control_1
CRAFT(Community Reinforcement And Family Training)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Family members of Alcoholics Anonymous who are not currently receiving treatment for alcoholism, etc.
Key exclusion criteria
1.Under the age of 18
2. Having a substance use disorder
3. Opportunities for interaction with the alcoholic less than 3 days per week
4. The alcoholic has a history of domestic violence, assault, use of weapons, or serious violence in the past two years.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kusano |
Organization
University of the Ryukyus
Division name
Faculty of Humanities and Social Science
Zip code
903-0213
Address
1,Senbaru, Nishihara-cho,Okinawa-ken,903-0213,Japan
TEL
098-895-8661
kusano@hs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Shingaki |
Organization
University of the Ryukyus
Division name
Graduate School of Humanities and Social Sciences
Zip code
903-0213
Address
1,Senbaru, Nishihara-cho,Okinawa-ken,903-0213,Japan
TEL
098-895-8661
Homepage URL
k198037@eve.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus
Address
1,Senbaru, Nishihara-cho,Okinawa-ken,903-0213,Japan
Tel
0988958661
kusano@hs.u-ryukyu.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
| 2022 | Year | 01 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053303
