Web-Based CBT Protocol for Treatment of Selective Mutism

May 19, 2014 updated by: A/Prof Daniel Fung Shuen Sheng, National Healthcare Group, Singapore

Effectiveness of a Web-Based CBT Protocol for Treatment of Selective Mutism in Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168937
        • Child Guidance Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meeky Mouse program
14-week "Meeky Mouse" program consists of 8 training sessions (psychoeducation and anxiety management) followed by 6 practice sessions (exposure using social skills training)
Behavioral: Meeky Mouse program
Placebo Comparator: Computer Games
14 weeks of interactive session with the therapist while playing computer games
Other: Computer Games

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Selective Mutism Questionnaire
Time Frame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on SMQ scores
Changes from pre-treatment (Week 0) to post-treatment (Week 14) on SMQ scores

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS total scores
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
Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS-C total scores
Clinical Global Impression (CGI)
Time Frame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on CGI-Severity and CGI-Improvement Ratings
Changes from pre-treatment (Week 0) to post-treatment (Week 14) on CGI-Severity and CGI-Improvement Ratings

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Healthcare Group, Singapore

Investigators

  • Principal Investigator: Daniel Fung, MBBS, MMed, Institute of Mental Health, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 12, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHG-SIG/05016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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