Selective MutismNCT02009839
Web-Based CBT Protocol for Treatment of Selective Mutism
A study testing Meeky Mouse program and Computer Games in people with Selective Mutism, run by National Healthcare Group, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Selective Mutism
- What is being tested?
- Meeky Mouse program and Computer Games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2005to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-12 years old
- primary clinical diagnosis of Selective Mutism
- confirmed diagnosis of Selective Mutism by structured clinical parent interview
- fluent in English
Who cannot join
- below average intellectual functioning
- the presence of autism and schizophrenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Selective Mutism
- Being tested
- Meeky Mouse program, Computer Games
- Keywords
- anxiety, frequency of speech, selective mutism
- Medical subject headings
- Mutism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meeky Mouse programBehavioural
Computer GamesOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Meeky Mouse program |
| Computer Games | Placebo comparator | 14 weeks of interactive session with the therapist while playing computer games Receives: Other: Computer Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective Mutism Questionnaire
Measured: 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)
Measured: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS total scores
Asian Children's Anxiety Scale-Child (ACAS-C)
Measured: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS-C total scores
Clinical Global Impression (CGI)
Measured: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on CGI-Severity and CGI-Improvement Ratings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startJul 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective MutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, A/Prof Daniel Fung Shuen Sheng, National Healthcare Group, Singapore
- Investigators
- Daniel Fung, MBBS, MMed, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009839
- Sponsor's protocol ID
- NHG-SIG/05016
- Status last verified
- May 2014
- First submitted
- 9 Dec 2013
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Web-Based CBT Protocol for Treatment of Selective Mutism in Singapore
- ClinicalTrials.gov ID
- NCT02009839
- Acronym / sponsor ID
- NHG-SIG/05016
- Conditions
- Selective Mutism
- Keywords
- anxiety, frequency of speech, selective mutism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Study start
- Jul 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meeky Mouse program | Experimental | Behavioral: Meeky Mouse program14-week "Meeky Mouse" program consists of 8 training sessions (psychoeducation and anxiety management) followed by 6 practice sessions (exposure using social skills training) |
| Computer Games | Placebo comparator | Other: Computer Games14 weeks of interactive session with the therapist while playing computer games |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 6-12 years old
- primary clinical diagnosis of Selective Mutism
- confirmed diagnosis of Selective Mutism by structured clinical parent interview
- fluent in English
Key exclusion criteria (2 listed)
- below average intellectual functioning
- the presence of autism and schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meeky Mouse program | Behavioural | Meeky Mouse program |
| Computer Games | Other | Computer Games |
Primary outcome
Selective Mutism Questionnaire
Time frame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on SMQ scores
3 secondary outcomes
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
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
Clinical Global Impression (CGI)
Time frame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on CGI-Severity and CGI-Improvement Ratings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
Related trials for Selective Mutism
Recruiting
VR Homework Exercises for Selective Mutism Treatment
Selective Mutism, Anxiety Disorder of Childhood
Recruiting
Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Fung, MBBS, MMed principal investigator
Institute of Mental Health, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meeky Mouse program and Computer Games in people with Selective Mutism, run by National Healthcare Group, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective Mutism Questionnaire (time frame: Changes from pre-treatment (Week 0) to post-treatment (Week 14) on SMQ scores). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.