UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043686 |
|---|---|
| Receipt number | R000049819 |
| Scientific Title | A study of the effects of online parent training for children with selective mutism |
| Date of disclosure of the study information | 2021/03/21 |
| Last modified on | 2022/03/31 21:51:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of the effects of online parent training for children with selective mutism
Acronym
A study of the effects of online parent training for children with selective mutism
Scientific Title
A study of the effects of online parent training for children with selective mutism
Scientific Title:Acronym
A study of the effects of online parent training for children with selective mutism
Region
| Japan |
Condition
Condition
Selective mutism
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to examine the effects of an online parent training intervention for parents of selective mutism children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The General Health Questionnaire
Parenting Stress Index
Scale on Young children's Anxiety Tendencies
Selective Mutism questionnaire-Revised
Key secondary outcomes
Positive and Negative Parenting Scale
Child Behavior Checklist
Homework records
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 | Other |
Interventions/Control_1
The online PT for this study will consist of 11 sessions of 2 hours each, once every two weeks. The sessions will be conducted using Zoom, a video communication application via the Internet. The sessions will be facilitated and explained by the researcher. During the training period, the participants will conduct homework.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Parents of children with selective mutism whose age is around 4 to 8 years old at the time of obtaining consent.
2. Parents of children who have been reported by themselves, their families, or other relevant persons that the child has difficulty speaking in social situations (nursery schools, kindergartens, schools, etc.) for at least one month.
Key exclusion criteria
1. Parents of children with total silence who have difficulty speaking at home as well as in social situations.
2. People who are unable to utilize the application for receiving online PT.
3. People who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Inoue |
Organization
Tottori University
Division name
Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code
683-8503
Address
86 Nishi-cho,Yonago-shi,Tottori Japan
TEL
0859386410
masahiko-inoue@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Yamanaka |
Organization
Tottori University
Division name
Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code
683-8503
Address
86 Nishi-cho,Yonago-shi,Tottori Japan
TEL
0859386410
Homepage URL
tysm1021@gmail.com
Sponsor or person
Institute
Tottori University.
Institute
Department
Personal name
Funding Source
Organization
Tottori University
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
Department of Clinical Psychology, Graduate School of Medical Sciences, Tottori University
Address
86 Nishi-cho,Yonago-shi,Tottori Japan
Tel
859386410
M20M4009U@edu.tottori-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
| 2021 | Year | 03 | Month | 21 | 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
17
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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 03 | Month | 21 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049819
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
