Selective MutismPhase 2NCT01002196
Randomised Controlled Treatment Study of Selective Mutism
A Phase 2 study testing Stimulus fading procedures and Guidance on defocused communication in people with Selective Mutism, run by Regionsenter for barn og unges psykiske helse at 1 site in Norway.
Trial summary
Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk. SM may cause great suffering and create problems, both socially and related to learning. SM is associated with social anxiety, neurodevelopmental delay and bilingualism. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Selective Mutism
- What is being tested?
- Stimulus fading procedures and Guidance on defocused communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2009to Dec 2011
- Phase
- Phase 2
- 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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from Eastern \& Southern Norway will be included if they fulfill the diagnostic criteria for SM
Who cannot join
- Children with SM and mental retardation with IQ below 50.
- Children with SM and psychosis or pervasive developmental disorders with the exception of Asperger syndrome and PDD Nos (DSM-IV)
- Children with SM who receive an active treatment for SM in the CAMHS
- Children with SM who are medicated for social anxiety.
- Children with SM where the parents do not understand Norwegian.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
Oslo, 0405
About this study
Official title: How to Help When Silence is Not Golden A RCT Study of Selective Mutism
Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk. SM may cause great suffering and create problems, both socially and related to learning. SM is associated with social anxiety, neurodevelopmental delay and bilingualism. The prevalence is about .7-8 ‰. Adequate assessment and treatment of SM is seldom provided in the mental health services. SM is considered hard to treat, and randomised treatment studies are lacking. This study will examine the effect of a manual based treatment for SM. The treatment consists of home- and kindergarten /school based interventions including behaviour techniques and psychoeducation. Defocused communication is a general treatment principle. Comorbidity, including neurodevelopmental delay /disorder, and predictors of outcome, will be examined. A pilot study was conducted to ensure the feasibility of the planned effectiveness study. Seven children, aged 3-5 years were included. Six has started treatment, and all talked in the kinder garden within the first 3 months. The present study will have a randomised controlled design with 1. Manual based intervention for 6 months compared to 2. Waiting list controls (3 months), and then manual based intervention. The sample: Children aged 3-9 years consecutively referred to the school psychology- or the mental health services in Oslo and Eastern Norway. Expected N = 24 based on the pilot study, is a sufficient sample size to answer our primary research question. The treatment will be given by a therapist from the research group or by a local clinician under supervision. The study can add essential knowledge on treatment of SM and make effective treatment available to clinicians in the community.
- Conditions
- Selective Mutism
- Being tested
- Stimulus fading procedures, Guidance on defocused communication
- Keywords
- Selective Mutism, Intervention
- Medical subject headings
- Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulus fading proceduresBehavioural
Also called stimulus fading technique, defocused communication
Core elements : 1.Behavior techniques (BT's) are used to gradually master the anxiety ("stimulus fading" and reward).
- Children are first met at home where they feel most safe, and the BT's are first conducted at home in cooperation with the parents.
3.The same interventions are then continued in the environment where the problem primarily exist (kindergarten / school) not at the clinic.
4.Defocused communication- and interaction is a general treatment principle (e.g. avoid looking directly at the child, sit beside not opposite to the child, no direct questioning, and communication is based upon a motivating activity, not about the child).
5.Frequent and short interventions. 6.Information to parents and teachers on how to communicate with children with SM
Guidance on defocused communicationBehavioural
Guidance and supervision to teachers working with the children with SM. Frequency: Twice during three months
| Study group | Role | What they receive |
|---|---|---|
| stimulus fading procedures | Experimental | Not described Receives: Behavioral: Stimulus fading procedures; Behavioral: Guidance on defocused communication |
| guidance of defocused communication | Active comparator | Not described Receives: Behavioral: Guidance on defocused communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
School version of the Selective Mutism Questionnaire (SSQ)
Measured: at 3, 6, 12 months
Secondary outcomes (1)
Clinical Global Impression Scale (CGI)
Measured: at 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionsenter for barn og unges psykiske helse
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Hanne Kristensen, Regionsenter for barn og unges psykiske helse
- Investigators
- Hanne Kristensen, MD, PhD, Principal investigator, Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002196
- Sponsor's protocol ID
- RegionsenterBUP
- Other IDs
- 190648/V50, Norwegian Research Council
- Status last verified
- Jun 2014
- First submitted
- 26 Oct 2009
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oerbeck B, Stein MB, Wentzel-Larsen T, Langsrud O, Kristensen H. A randomized controlled trial of a home and school-based intervention for selective mutism - defocused communication and behavioural techniques. Child Adolesc Ment Health. 2014 Sep;19(3):192-198. doi: 10.1111/camh.12045. Epub 2013 Oct 26.
PubMed 32878377Oerbeck B, Overgaard KR, Stein MB, Pripp AH, Kristensen H. Treatment of selective mutism: a 5-year follow-up study. Eur Child Adolesc Psychiatry. 2018 Aug;27(8):997-1009. doi: 10.1007/s00787-018-1110-7. Epub 2018 Jan 22.
PubMed 29357099Oerbeck B, Stein MB, Pripp AH, Kristensen H. Selective mutism: follow-up study 1 year after end of treatment. Eur Child Adolesc Psychiatry. 2015 Jul;24(7):757-66. doi: 10.1007/s00787-014-0620-1. Epub 2014 Sep 30.
PubMed 25267381
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Help When Silence is Not Golden A RCT Study of Selective Mutism
- ClinicalTrials.gov ID
- NCT01002196
- Acronym / sponsor ID
- RegionsenterBUP
- Conditions
- Selective Mutism
- Keywords
- Selective Mutism, Intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Regionsenter for barn og unges psykiske helseUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Oct 2009 (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.
Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk. SM may cause great suffering and create problems, both socially and related to learning. SM is associated with social anxiety, neurodevelopmental delay and bilingualism. The prevalence is about .7-8 ‰. Adequate assessment and treatment of SM is seldom provided in the mental health services. SM is considered hard to treat, and randomised treatment studies are lacking. This study will examine the effect of a manual based treatment for SM. The treatment consists of home- and kindergarten /school based interventions including behaviour techniques and psychoeducation. Defocused communication is a general treatment principle. Comorbidity, including neurodevelopmental delay /disorder, and predictors of outcome, will be examined. A pilot study was conducted to ensure the feasibility of the planned effectiveness study. Seven children, aged 3-5 years were included. Six has started treatment, and all talked in the kinder garden within the first 3 months. The present study will have a randomised controlled design with 1. Manual based intervention for 6 months compared to 2. Waiting list controls (3 months), and then manual based intervention. The sample: Children aged 3-9 years consecutively referred to the school psychology- or the mental health services in Oslo and Eastern Norway. Expected N = 24 based on the pilot study, is a sufficient sample size to answer our primary research question. The treatment will be given by a therapist from the research group or by a local clinician under supervision. The study can add essential knowledge on treatment of SM and make effective treatment available to clinicians in the community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulus fading procedures | Experimental | Behavioral: Stimulus fading procedures, Behavioral: Guidance on defocused communication |
| guidance of defocused communication | Active comparator | Behavioral: Guidance on defocused communication |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from Eastern \& Southern Norway will be included if they fulfill the diagnostic criteria for SM
Key exclusion criteria (5 listed)
- Children with SM and mental retardation with IQ below 50.
- Children with SM and psychosis or pervasive developmental disorders with the exception of Asperger syndrome and PDD Nos (DSM-IV)
- Children with SM who receive an active treatment for SM in the CAMHS
- Children with SM who are medicated for social anxiety.
- Children with SM where the parents do not understand Norwegian.
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 |
|---|---|---|
| Stimulus fading proceduresAlso: stimulus fading technique, defocused communicationCore elements : 1.Behavior techniques (BT's) are used to gradually master the anxiety ("stimulus fading" and reward). 2. Children are first met at home where they feel most safe, and the BT's are first conducted at home in cooperation with the parents. 3.The same interventions are then continued in the environment where the problem primarily exist (kindergarten / school) not at the clinic. 4.Defocused communication- and interaction is a general treatment principle (e.g. avoid looking directly at the child, sit beside not opposite to the child, no direct questioning, and communication is based upon a motivating activity, not about the child). 5.Frequent and short interventions. 6.Information to parents and teachers on how to communicate with children with SM | Behavioural | stimulus fading procedures |
| Guidance on defocused communicationGuidance and supervision to teachers working with the children with SM. Frequency: Twice during three months | Behavioural | guidance of defocused communication, stimulus fading procedures |
Primary outcome
School version of the Selective Mutism Questionnaire (SSQ)
Time frame: at 3, 6, 12 months
1 secondary outcome
Clinical Global Impression Scale (CGI)
Time frame: at 3, 6, 12 months
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 Jun 2014.
- Derived from this study: PubMed 32878377Oerbeck B, Stein MB, Wentzel-Larsen T, Langsrud O, Kristensen H. A randomized controlled trial of a home and school-based intervention for selective mutism - defocused communication and behavioural techniques. Child Adolesc Ment Health. 2014 Sep;19(3):192-198. doi: 10.1111/camh.12045. Epub 2013 Oct 26.
- Derived from this study: PubMed 29357099Oerbeck B, Overgaard KR, Stein MB, Pripp AH, Kristensen H. Treatment of selective mutism: a 5-year follow-up study. Eur Child Adolesc Psychiatry. 2018 Aug;27(8):997-1009. doi: 10.1007/s00787-018-1110-7. Epub 2018 Jan 22.
- Derived from this study: PubMed 25267381Oerbeck B, Stein MB, Pripp AH, Kristensen H. Selective mutism: follow-up study 1 year after end of treatment. Eur Child Adolesc Psychiatry. 2015 Jul;24(7):757-66. doi: 10.1007/s00787-014-0620-1. Epub 2014 Sep 30.
Related trials for Selective Mutism
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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, MD, PhD principal investigator
Regional Centre for 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 Phase 2 study testing Stimulus fading procedures and Guidance on defocused communication 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 20 Jun 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
School version of the Selective Mutism Questionnaire (SSQ) (time frame: at 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002196, which also lists 3 linked publications.
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 Jun 2014.