What Treatment Works for Children With Selective Mutism?

This study has been completed.
Sponsor:
Collaborator:
Ullevaal University Hospital
Information provided by:
Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier:
NCT00554749
First received: November 6, 2007
Last updated: November 18, 2010
Last verified: November 2010
  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: Interventions at home, in the kindergarten/school

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: What Treatment Works for Children With Selective Mutism? A Treatment Pilot Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • School Speech Questionnaire (SSQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 7
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554749

Locations
Norway
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
Investigators
Principal Investigator: Hanne Kristensen, Ph.D. Centre of child and adolescent mental health, Eastern and Southern Norway
  More Information

No publications provided

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
Study First Received: November 6, 2007
Results First Received: July 2, 2009
Last Updated: November 18, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Mutism
Communication Disorders
Language Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders

ClinicalTrials.gov processed this record on October 21, 2014