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Web-Based CBT Protocol for Treatment of Selective Mutism

Primary Purpose

Selective Mutism

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Meeky Mouse program
Computer Games
Sponsored by
National Healthcare Group, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Selective Mutism focused on measuring anxiety, frequency of speech, selective mutism

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 6-12 years old
  • primary clinical diagnosis of Selective Mutism
  • confirmed diagnosis of Selective Mutism by structured clinical parent interview
  • fluent in English

Exclusion Criteria:

  • below average intellectual functioning
  • the presence of autism and schizophrenia

Sites / Locations

  • Child Guidance Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Meeky Mouse program

Computer Games

Arm Description

14-week "Meeky Mouse" program consists of 8 training sessions (psychoeducation and anxiety management) followed by 6 practice sessions (exposure using social skills training)

14 weeks of interactive session with the therapist while playing computer games

Outcomes

Primary Outcome Measures

Selective Mutism Questionnaire

Secondary Outcome Measures

Asian Children's Anxiety Scale-Caretaker Version (ACAS)
Asian Children's Anxiety Scale-Child (ACAS-C)
Clinical Global Impression (CGI)

Full Information

First Posted
December 9, 2013
Last Updated
May 19, 2014
Sponsor
National Healthcare Group, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02009839
Brief Title
Web-Based CBT Protocol for Treatment of Selective Mutism
Official Title
Effectiveness of a Web-Based CBT Protocol for Treatment of Selective Mutism in Singapore
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Healthcare Group, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim of this study is to examine the effectiveness of a web-based CBT protocol (entitled Meeky Mouse) in the treatment of children with Selective Mutism in Singapore. The researchers hypothesized that the Meeky Mouse program would be associated with higher frequency of speaking behaviors, lower levels of anxiety, greater improvements in clinician-rated severity of mental illness, and higher clinician-rated improvement scores at post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selective Mutism
Keywords
anxiety, frequency of speech, selective mutism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meeky Mouse program
Arm Type
Experimental
Arm Description
14-week "Meeky Mouse" program consists of 8 training sessions (psychoeducation and anxiety management) followed by 6 practice sessions (exposure using social skills training)
Arm Title
Computer Games
Arm Type
Placebo Comparator
Arm Description
14 weeks of interactive session with the therapist while playing computer games
Intervention Type
Behavioral
Intervention Name(s)
Meeky Mouse program
Intervention Type
Other
Intervention Name(s)
Computer Games
Primary Outcome Measure Information:
Title
Selective Mutism Questionnaire
Time Frame
Changes from pre-treatment (Week 0) to post-treatment (Week 14) on SMQ scores
Secondary Outcome Measure Information:
Title
Asian Children's Anxiety Scale-Caretaker Version (ACAS)
Time Frame
Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS total scores
Title
Asian Children's Anxiety Scale-Child (ACAS-C)
Time Frame
Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS-C total scores
Title
Clinical Global Impression (CGI)
Time Frame
Changes from pre-treatment (Week 0) to post-treatment (Week 14) on CGI-Severity and CGI-Improvement Ratings

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 6-12 years old primary clinical diagnosis of Selective Mutism confirmed diagnosis of Selective Mutism by structured clinical parent interview fluent in English Exclusion Criteria: below average intellectual functioning the presence of autism and schizophrenia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Fung, MBBS, MMed
Organizational Affiliation
Institute of Mental Health, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Guidance Clinic
City
Singapore
ZIP/Postal Code
168937
Country
Singapore

12. IPD Sharing Statement

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Web-Based CBT Protocol for Treatment of Selective Mutism

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