UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051540 |
|---|---|
| Receipt number | R000058778 |
| Scientific Title | A group family psychoeducation for adolescents with anorexia nervosa: online versus face to face |
| Date of disclosure of the study information | 2023/07/07 |
| Last modified on | 2023/08/24 14:46:51 |
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Basic information
Public title
A group family psychoeducation for adolescents with anorexia nervosa: online versus face to face
Acronym
A group family psychoeducation for adolescents with anorexia nervosa: online versus face to face
Scientific Title
A group family psychoeducation for adolescents with anorexia nervosa: online versus face to face
Scientific Title:Acronym
A group family psychoeducation for adolescents with anorexia nervosa: online versus face to face
Region
| Japan |
Condition
Condition
anorexia nervosa
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the feasibility of an online group family psychoeducation for children and adolescents with anorexia nervosa.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
completion rate of the psychoeducation program
Key secondary outcomes
Changes in each measure (below 1-10) between the pre- and post- psychoeducation program
1) Depressive symptoms (family) (Beck Depression Inventory - Second Edition)
2) Family function
3) Quality of Life (family) (SF-36)
4) Satisfaction with the psychoeducation program (questionnaire)
5) Knowledge about anorexia nervosa (questionnaire)
6) Knowledge about desirable family reaction (questionnaire)
7) Family statements
8) Standard body weight ratio (children and adolescents)
9) Questionnaire about the benefits and difficulties of an online psychoeducation program by family
10) Questionnaire about the benefits and difficulties of an online psychoeducation program by therapists
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Four sessions of a group family psychoeducation for children and adolescents with anorexia nervosa via online
Interventions/Control_2
Four sessions of a group family psychoeducation for children and adolescents with anorexia nervosa via face-to-face
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
| 19 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Families of children and adolescents with a clinical diagnosis of anoreixa nervosa according to DSM-5 criteria
2)Families of children and adolescents with anorexia nervosa under 19 years of age
3)Families assessed by the attending doctors and the principal investigator as eligible
4)Families consenting to participation in this study
Key exclusion criteria
1)Families who cannot attend this study
2)Families assessed by the attending doctors as unfit for this study
3)Families assessed by the principal investigator as unfit for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Kuge |
Organization
Shinshu University Hospital
Division name
Mental Health Clinic for Children
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Ngano 390-8621, JAPAN
TEL
0263-37-3060
rkuge@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Miku |
| Middle name | |
| Last name | Nakano |
Organization
Shinshu University Hospital
Division name
Rehabilitation Center
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Ngano 390-8621, JAPAN
TEL
0263-37-2836
Homepage URL
nakano-m5@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
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
the ethics committee of Shinshu University School of Medicine
Address
3-1-1, Asahi, Matsumoto, Ngano 390-8621, JAPAN
Tel
0263-37-2572
mdrinri@shinshu-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
| 2023 | Year | 07 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058778
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
