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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043686
Receipt No. 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 2021/09/20

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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
Email 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
Email tysm1021@gmail.com

Sponsor
Institute Tottori University.
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.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


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