Selective MutismNCT00554749
What Treatment Works for Children With Selective Mutism?
A study testing Interventions at home, in the kindergarten/school in people with Selective Mutism, run by Regionsenter for barn og unges psykiske helse at 1 site in Norway.
Trial summary
The purpose of this pilot study is to explore the outcome of a manual based treatment for children with Selective Mutism Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Selective Mutism
- What is being tested?
- Interventions at home, in the kindergarten/school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a clinical diagnosis of Selective Mutism (SM)
Who cannot join
- Children with Mental Retardation (IQ<50)
- Children with Pervasive Developmental Disorder (PDD)
- Children with SM in active treatment
- Children with SM on medication
- Children whose parents are non-Norwegian speaking
Trial locations and contacts
1 site in 1 country.
Norway1 site
Centre for child and adolescent mental health, Eastern and Southern Norway
Oslo, 0484
About this study
Official title: What Treatment Works for Children With Selective Mutism? A Treatment Pilot Study
The purpose of this pilot study is to explore the outcome of a manual based treatment for children with Selective Mutism
Read the detailed description
Objectives:
The main aim of this pilot study is to increase our knowledge on interventions for Selective Mutism (SM), a childhood condition characterized by a persistent lack of speech in specific situations despite the ability to comprehend and use language. A survey on the treatment offered this group in Norway 1997-2000 showed great variations in therapeutic approach and the overall outcome was poor. Correspondent with the notion of SM as a variant of social anxiety, several case studies have described successful treatments using behaviour techniques (BT's) such as stimulus fading and shaping. In addition, the author's clinical experience is that "defocusing in communication" (e.g. regulation of gaze contact; sitting beside instead of in front of the child, avoiding direct questioning, talking about interesting but impersonal topics) represents another important toil in getting the mute child to start talking. However, to date there are no randomized controlled SM treatment studies, and in fact we know little of what works best to help these children. Our research group has developed an assessment- and treatment manual for children with SM.
In this exploring pilot study referred children with SM aged 3-5 years (n=7) will be given an intervention according to the treatment manual. The intervention is conducted at home and in the kindergarten or at school and includes stimulus fading techniques with weekly sessions. Therapists will be members of the research group or local therapist under supervision.
- Conditions
- Selective Mutism
- Being tested
- Interventions at home, in the kindergarten/school
- Keywords
- Selective mutism, Children, Treatment
- Medical subject headings
- Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions at home, in the kindergarten/schoolBehavioural
Also called Stimulus fading interventions
Weekly interventions including behavior techniques (stimulus fading)
| Study group | Role | What they receive |
|---|---|---|
| 1 Behavioral intervention | Other | Behavioral intervention in all seven subjects Weekly sessions in the home and the kindergarten using defocused communication and stimulus fading interventions Receives: Behavioral: Interventions at home, in the kindergarten/school |
What is being measured
The primary outcome is the main question the study is designed to answer.
School Speech Questionnaire (SSQ)
SSQ is a teacher-report measure assessing the frequency of the child's speaking behaviour at school. It is a 9-item questionnaire. Each item has four possible responses, ranging 0 (never), 1 (seldom), 2 (often) and 3 (always). The standard sum score is added up from the six questions (as defined by its author Lindsey Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3.(worst value=0 and best value=3)
Measured: 6 months
Secondary outcomes (1)
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
6 Predefined treatment goals reflecting speaking levels from 1 through to 6. 1: Speaks to the therapist(T) in a separate room in the kindergarten with parent (P) present. 2: Speaks to T in a separate room without P. 3: Speaks to a teacher in a separate room with T present. 4: Speaks to other teachers in a separate room with T present. 5: Speaks to teachers in some kindergarten settings without T present. 6: Speaks to teachers in all settings in kindergarten without T present. Each child receives one score at end of treatment according to their acquired level (worst value=1, best value =6)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionsenter for barn og unges psykiske helse
- Sponsor type
- University, hospital or other
- Collaborators
- Ullevaal University Hospital
- Investigators
- Hanne Kristensen, Ph.D., Principal investigator, Centre of child and adolescent mental health, Eastern and Southern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554749
- Sponsor's protocol ID
- 1.2006.2116
- Other IDs
- 15968
- Status last verified
- Nov 2010
- First submitted
- 6 Nov 2007
- Last updated
- 25 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Treatment Works for Children With Selective Mutism? A Treatment Pilot Study
- ClinicalTrials.gov ID
- NCT00554749
- Acronym / sponsor ID
- 1.2006.2116
- Conditions
- Selective Mutism
- Keywords
- Selective mutism, Children, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Regionsenter for barn og unges psykiske helseUniversity, hospital or other
- Collaborators
- Ullevaal University Hospital
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Posted 18 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to explore the outcome of a manual based treatment for children with Selective Mutism
Detailed description
Objectives:
The main aim of this pilot study is to increase our knowledge on interventions for Selective Mutism (SM), a childhood condition characterized by a persistent lack of speech in specific situations despite the ability to comprehend and use language. A survey on the treatment offered this group in Norway 1997-2000 showed great variations in therapeutic approach and the overall outcome was poor. Correspondent with the notion of SM as a variant of social anxiety, several case studies have described successful treatments using behaviour techniques (BT's) such as stimulus fading and shaping. In addition, the author's clinical experience is that "defocusing in communication" (e.g. regulation of gaze contact; sitting beside instead of in front of the child, avoiding direct questioning, talking about interesting but impersonal topics) represents another important toil in getting the mute child to start talking. However, to date there are no randomized controlled SM treatment studies, and in fact we know little of what works best to help these children. Our research group has developed an assessment- and treatment manual for children with SM.
In this exploring pilot study referred children with SM aged 3-5 years (n=7) will be given an intervention according to the treatment manual. The intervention is conducted at home and in the kindergarten or at school and includes stimulus fading techniques with weekly sessions. Therapists will be members of the research group or local therapist under supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Behavioral intervention | Other | Behavioral: Interventions at home, in the kindergarten/schoolBehavioral intervention in all seven subjects Weekly sessions in the home and the kindergarten using defocused communication and stimulus fading interventions |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with a clinical diagnosis of Selective Mutism (SM)
Key exclusion criteria (5 listed)
- Children with Mental Retardation (IQ<50)
- Children with Pervasive Developmental Disorder (PDD)
- Children with SM in active treatment
- Children with SM on medication
- Children whose parents are non-Norwegian speaking
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 |
|---|---|---|
| Interventions at home, in the kindergarten/schoolAlso: Stimulus fading interventionsWeekly interventions including behavior techniques (stimulus fading) | Behavioural | 1 Behavioral intervention |
Primary outcome
School Speech Questionnaire (SSQ)
Time frame: 6 months
SSQ is a teacher-report measure assessing the frequency of the child's speaking behaviour at school. It is a 9-item questionnaire. Each item has four possible responses, ranging 0 (never), 1 (seldom), 2 (often) and 3 (always). The standard sum score is added up from the six questions (as defined by its author Lindsey Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3.(worst value=0 and best value=3)
1 secondary outcome
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Hanne Kristensen, Ph.D. principal investigator
Centre of child and adolescent mental health, Eastern and Southern Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions at home, in the kindergarten/school in people with Selective Mutism, run by Regionsenter for barn og unges psykiske helse at 1 site in Norway.
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 1 inclusion and 5 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 25 Nov 2010. 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 Norway. 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. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
School Speech Questionnaire (SSQ) (time frame: 6 months). 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 25 Nov 2010; AzTrials last refreshed its copy on 6 Nov 2026.