- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554749
What Treatment Works for Children With Selective Mutism?
What Treatment Works for Children With Selective Mutism? A Treatment Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0484
- Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1 Behavioral intervention
Behavioral intervention in all seven subjects Weekly sessions in the home and the kindergarten using defocused communication and stimulus fading interventions
|
Weekly interventions including behavior techniques (stimulus fading)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hanne Kristensen, Ph.D., Centre of child and adolescent mental health, Eastern and Southern Norway
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.2006.2116
- 15968 (Other Identifier: Reg. Committee for medical & health research ethics, Norway)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.