NCT00554749

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 18, 2010

Completed
Last Updated

November 25, 2010

Status Verified

November 1, 2010

Enrollment Period

1.1 years

First QC Date

November 6, 2007

Results QC Date

July 2, 2009

Last Update Submit

November 18, 2010

Conditions

Keywords

Selective mutismChildrenTreatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)

    6 months

Study Arms (1)

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

Behavioral: Interventions at home, in the kindergarten/school

Interventions

Weekly interventions including behavior techniques (stimulus fading)

Also known as: Stimulus fading interventions
1 Behavioral intervention

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with a clinical diagnosis of Selective Mutism (SM)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oslo, 0484, Norway

Location

MeSH Terms

Conditions

Mutism

Interventions

Schools

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Results Point of Contact

Title
Dr. Hanne Kristensen
Organization
Centre for Child and Adolescent Mental Health, Eastern and Southern Norway

Study Officials

  • Hanne Kristensen, Ph.D.

    Centre of child and adolescent mental health, Eastern and Southern Norway

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 7, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 25, 2010

Results First Posted

November 18, 2010

Record last verified: 2010-11

Locations