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What Treatment Works for Children With Selective Mutism?

Primary Purpose

Selective Mutism

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Interventions at home, in the kindergarten/school
Sponsored by
Regionsenter for barn og unges psykiske helse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Selective Mutism focused on measuring Selective mutism, Children, Treatment

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for child and adolescent mental health, Eastern and Southern Norway

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1 Behavioral intervention

Arm Description

Behavioral intervention in all seven subjects Weekly sessions in the home and the kindergarten using defocused communication and stimulus fading interventions

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
November 6, 2007
Last Updated
November 18, 2010
Sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
Ullevaal University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00554749
Brief Title
What Treatment Works for Children With Selective Mutism?
Official Title
What Treatment Works for Children With Selective Mutism? A Treatment Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
Ullevaal University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selective Mutism
Keywords
Selective mutism, Children, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Behavioral intervention
Arm Type
Other
Arm Description
Behavioral intervention in all seven subjects Weekly sessions in the home and the kindergarten using defocused communication and stimulus fading interventions
Intervention Type
Behavioral
Intervention Name(s)
Interventions at home, in the kindergarten/school
Other Intervention Name(s)
Stimulus fading interventions
Intervention Description
Weekly interventions including behavior techniques (stimulus fading)
Primary Outcome Measure Information:
Title
School Speech Questionnaire (SSQ)
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Kristensen, Ph.D.
Organizational Affiliation
Centre of child and adolescent mental health, Eastern and Southern Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for child and adolescent mental health, Eastern and Southern Norway
City
Oslo
ZIP/Postal Code
0484
Country
Norway

12. IPD Sharing Statement

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