UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049819