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What Treatment Works for Children With Selective Mutism?

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ClinicalTrials.gov Identifier: NCT00554749
Recruitment Status : Completed
First Posted : November 7, 2007
Results First Posted : November 18, 2010
Last Update Posted : November 25, 2010
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Study Description
Brief Summary:
The purpose of this pilot study is to explore the outcome of a manual based treatment for children with Selective Mutism

Condition or disease Intervention/treatment
Selective Mutism Behavioral: Interventions at home, in the kindergarten/school

Detailed Description:


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: What Treatment Works for Children With Selective Mutism? A Treatment Pilot Study
Study Start Date : November 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
1 Behavioral intervention
Behavioral intervention in all seven subjects Weekly sessions in the home and the kindergarten using defocused communication and stimulus fading interventions
Behavioral: Interventions at home, in the kindergarten/school
Weekly interventions including behavior techniques (stimulus fading)
Other Name: Stimulus fading interventions

Outcome Measures

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6) [ Time Frame: 6 months ]
    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)

Eligibility Criteria

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children with a clinical diagnosis of Selective Mutism (SM)

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554749

Centre for child and adolescent mental health, Eastern and Southern Norway
Oslo, Norway, 0484
Sponsors and Collaborators
Regionsenter for barn og unges psykiske helse
Ullevaal University Hospital
Principal Investigator: Hanne Kristensen, Ph.D. Centre of child and adolescent mental health, Eastern and Southern Norway
More Information

Responsible Party: Hanne Kristensen, MD, PhD, Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
ClinicalTrials.gov Identifier: NCT00554749     History of Changes
Other Study ID Numbers: 1.2006.2116
15968 ( Other Identifier: Reg. Committee for medical & health research ethics, Norway )
First Posted: November 7, 2007    Key Record Dates
Results First Posted: November 18, 2010
Last Update Posted: November 25, 2010
Last Verified: November 2010

Keywords provided by Regionsenter for barn og unges psykiske helse:
Selective mutism

Additional relevant MeSH terms:
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders