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What Treatment Works for Children With Selective Mutism?
This study is currently recruiting participants.
Verified by Regionsenter for barn og unges psykiske helse, June 2008
Sponsors and Collaborators: Regionsenter for barn og unges psykiske helse
Ullevaal University Hospital
Information provided by: Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier: NCT00554749
  Purpose

The purpose of this pilot study is to explore the outcome of a manual based treatment for children with Selective Mutism


Condition Intervention
Selective Mutism
Behavioral: Home- and school based intervention

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: What Treatment Works for Children With Selective Mutism? A Treatment Pilot Study

Further study details as provided by Regionsenter for barn og unges psykiske helse:

Primary Outcome Measures:
  • Selective Mutism Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI - Severity & Improvement Scales [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Behavioral: Home- and school based intervention
Weekly home- and schoolbased interventions including behavior techniques (stimulus fading)

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 4-9 years (n=7) will be given an intervention according to the treatment manual. The intervention is home-and kindergarten/school based and include stimulus fading techniques with weekly sessions. Therapists will be members of the research group or local therapist under supervision.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children with Mental Retardation (IQ<50)
  • Children with PDD
  • Children with SM in active treatment
  • Children with SM on medication
  • Children whose parents are non-Norwegian speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554749

Contacts
Contact: Hanne Kristensen, Ph.D. 22 58 60 00 ext + 47 hanne.kristensen@r-bup.no

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

Responsible Party: Centre for Child and Adolescent Mental Health, Eastern and Southern Norway ( Hanne Kristensen, MD, PhD )
Study ID Numbers: 1.2006.2116
Study First Received: November 6, 2007
Last Updated: July 2, 2008
ClinicalTrials.gov Identifier: NCT00554749  
Health Authority: Norway: The National Committees for Research Ethics in Norway

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

Study placed in the following topic categories:
Signs and Symptoms
Speech Disorders
Mental Disorders
Mutism
Mental Disorders Diagnosed in Childhood
Elective mutism
Neurologic Manifestations
Language Disorders
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009