NCT02009839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

December 9, 2013

Last Update Submit

May 19, 2014

Conditions

Keywords

anxietyfrequency of speechselective mutism

Outcome Measures

Primary Outcomes (1)

  • Selective Mutism Questionnaire

    Changes from pre-treatment (Week 0) to post-treatment (Week 14) on SMQ scores

Secondary Outcomes (3)

  • Asian Children's Anxiety Scale-Caretaker Version (ACAS)

    Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS total scores

  • Asian Children's Anxiety Scale-Child (ACAS-C)

    Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS-C total scores

  • Clinical Global Impression (CGI)

    Changes from pre-treatment (Week 0) to post-treatment (Week 14) on CGI-Severity and CGI-Improvement Ratings

Study Arms (2)

Meeky Mouse program

EXPERIMENTAL

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

Computer Games

PLACEBO COMPARATOR

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

Other: Computer Games

Interventions

Meeky Mouse program
Computer Games

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Guidance Clinic

Singapore, 168937, Singapore

Location

MeSH Terms

Conditions

MutismAnxiety Disorders

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Daniel Fung, MBBS, MMed

    Institute of Mental Health, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

July 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations