What Treatment Works for Children With Selective Mutism?

Selective Mutism Clinical Trial

Official title:

What Treatment Works for Children With Selective Mutism? A Treatment Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554749
• Other study ID #: 1.2006.2116
• Secondary ID: 15968
• Status: Completed
• Phase: N/A
• First received: November 6, 2007
• Last updated: November 18, 2010
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2010
• Source: Regionsenter for barn og unges psykiske helse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 9 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mutism
• Selective Mutism

Intervention

Behavioral:
• Interventions at home, in the kindergarten/school
Weekly interventions including behavior techniques (stimulus fading)

Locations

Country	Name	City	State
Norway	Centre for child and adolescent mental health, Eastern and Southern Norway	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Regionsenter for barn og unges psykiske helse	Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months	No
Secondary	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)	6 months	No