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| ID | Type | Description | Link |
|---|---|---|---|
| 15968 | Other Identifier | Reg. Committee for medical & health research ethics, Norway |
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| Name | Class |
|---|---|
| Ullevaal University Hospital | OTHER |
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The purpose of this pilot study is to explore the outcome of a manual based treatment for children with Selective Mutism
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Behavioral intervention | Other | Behavioral intervention in all seven subjects Weekly sessions in the home and the kindergarten using defocused communication and stimulus fading interventions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventions at home, in the kindergarten/school | Behavioral | Weekly interventions including behavior techniques (stimulus fading) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanne Kristensen, Ph.D. | Centre of child and adolescent mental health, Eastern and Southern Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for child and adolescent mental health, Eastern and Southern Norway | Oslo | 0484 | Norway |
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November, 2007 to July, 2008.Location: medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral | All participants received identical behavioral treatment with no control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral | All participants received identical behavioral treatment with no control group. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral | All participants received identical behavioral treatment with no control group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hanne Kristensen | Centre for Child and Adolescent Mental Health, Eastern and Southern Norway | +4722586000 | hanne.kristensen@r-bup.no |
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| ID | Term |
|---|---|
| D009155 | Mutism |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D012574 | Schools |
| ID | Term |
|---|---|
| D000072182 | Non-Medical Public and Private Facilities |
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| 6 months |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 and 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 L. Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3(worst value=0,best value=3). | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
|
| 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) | All participants analyzed | Posted | Number | participants | 6 months |
|
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| 0 |
| 7 |
| 0 |
| 7 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|
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| Level 3 |
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| Level 2 |
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| Level 1 |
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