UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051993 |
|---|---|
| Receipt number | R000058896 |
| Scientific Title | A Japanese version of multi-family therapy for children and adolescents with anorexia nervosa: a feasibility study |
| Date of disclosure of the study information | 2023/08/24 |
| Last modified on | 2023/08/24 15:26:46 |
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Basic information
Public title
A Japanese version of multi-family therapy for children and adolescents with anorexia nervosa: a feasibility study
Acronym
A Japanese version of multi-family therapy for children and adolescents with anorexia nervosa: a feasibility study
Scientific Title
A Japanese version of multi-family therapy for children and adolescents with anorexia nervosa: a feasibility study
Scientific Title:Acronym
A Japanese version of multi-family therapy for children and adolescents with anorexia nervosa: a feasibility study
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 a Japanese version of multifamily therapy 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
Qualitative data obtained through exploratory interviews (children's, adolescents', and families' narratives about the changes that occurred in the treatment program and the reasons for the changes)
Key secondary outcomes
Observation records (the changes to children, adolescents and families that occurred in the treatment program and the reasons for the changes)
Reflections of the children, adolescents and families on the treatment program
Completion rate of treatment program
Changes in each measure (below1-10) between the pre-and post-treatment program
1)Standard body weight ratio (children/adolescents)
2)Children's version of Eating Attitude Test with 26 items/The Eating Attitude Test with 26 items (children/adolescents)
3)Motivational ruler (children/adolescents)
4)Beck Depression Inventory-Second Edition (children/adolescents)
5)Rosenberg Self-Esteem Scale(RSES)(children/adolescents)
6)Client Satisfaction Questionnaire (CSQ-8) (children/adolescents)(post)
7)Beck Depression Inventory-Second Edition (families)
8)RSES (families)
9)Family functction (families)
10)CSQ-8 (families)(post)
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Eight sessions of a multifamily therapy for children and adolescents with anorexia nervosa
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
| 13 | years-old | <= |
Age-upper limit
| 19 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with a clinical diagnosis of anorexia nervosa according to DSM-5 criteria
2) Patients between 13 and 19 years of age and their caregivers
3) Patients and their caregivers assessed by the attending doctors and the principal investigator as eligible
4) Patients and their caregivers consenting to participation in this study
Key exclusion criteria
1) Patients who are physically unstable and assessed by the attending doctors as unfit for this study
2) Patients who have history of psychosis
3) Patients who have active suicidality
4) Patients who don't eat by mouth
5) Patients whose caregivers cannot attend treatment
6) Patients and their caregivers who have not received psychoeducation about anorexia nervosa that is commonly offered
7) Patients who assessed by the principal investigator as unfit for this study
Target sample size
16
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 | 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
Homepage URL
rkuge@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
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 | 08 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2025 | 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 | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058896
