Randomised Controlled Treatment Study of Selective Mutism
Primary Purpose
Selective Mutism
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Stimulus fading procedures
Guidance on defocused communication
Sponsored by
About this trial
This is an interventional treatment trial for Selective Mutism focused on measuring Selective Mutism, Intervention
Eligibility Criteria
Inclusion Criteria:
- Children from Eastern & Southern Norway will be included if they fulfill the diagnostic criteria for SM
Exclusion Criteria:
- Children with SM and mental retardation with IQ below 50.
- Children with SM and psychosis or pervasive developmental disorders with the exception of Asperger syndrome and PDD Nos (DSM-IV)
- Children with SM who receive an active treatment for SM in the CAMHS
- Children with SM who are medicated for social anxiety.
- Children with SM where the parents do not understand Norwegian.
Sites / Locations
- Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stimulus fading procedures
guidance of defocused communication
Arm Description
Outcomes
Primary Outcome Measures
School version of the Selective Mutism Questionnaire (SSQ)
Secondary Outcome Measures
Clinical Global Impression Scale (CGI)
Full Information
NCT ID
NCT01002196
First Posted
October 26, 2009
Last Updated
June 19, 2014
Sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT01002196
Brief Title
Randomised Controlled Treatment Study of Selective Mutism
Official Title
How to Help When Silence is Not Golden A RCT Study of Selective Mutism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
The Research Council of Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk. SM may cause great suffering and create problems, both socially and related to learning. SM is associated with social anxiety, neurodevelopmental delay and bilingualism. The prevalence is about .7-8 ‰. Adequate assessment and treatment of SM is seldom provided in the mental health services. SM is considered hard to treat, and randomised treatment studies are lacking. This study will examine the effect of a manual based treatment for SM. The treatment consists of home- and kindergarten /school based interventions including behaviour techniques and psychoeducation. Defocused communication is a general treatment principle. Comorbidity, including neurodevelopmental delay /disorder, and predictors of outcome, will be examined. A pilot study was conducted to ensure the feasibility of the planned effectiveness study. Seven children, aged 3-5 years were included. Six has started treatment, and all talked in the kinder garden within the first 3 months. The present study will have a randomised controlled design with 1. Manual based intervention for 6 months compared to 2. Waiting list controls (3 months), and then manual based intervention. The sample: Children aged 3-9 years consecutively referred to the school psychology- or the mental health services in Oslo and Eastern Norway. Expected N = 24 based on the pilot study, is a sufficient sample size to answer our primary research question. The treatment will be given by a therapist from the research group or by a local clinician under supervision. The study can add essential knowledge on treatment of SM and make effective treatment available to clinicians in the community.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selective Mutism
Keywords
Selective Mutism, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stimulus fading procedures
Arm Type
Experimental
Arm Title
guidance of defocused communication
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Stimulus fading procedures
Other Intervention Name(s)
stimulus fading technique, defocused communication
Intervention Description
Core elements : 1.Behavior techniques (BT's) are used to gradually master the anxiety ("stimulus fading" and reward).
2. Children are first met at home where they feel most safe, and the BT's are first conducted at home in cooperation with the parents.
3.The same interventions are then continued in the environment where the problem primarily exist (kindergarten / school) not at the clinic.
4.Defocused communication- and interaction is a general treatment principle (e.g. avoid looking directly at the child, sit beside not opposite to the child, no direct questioning, and communication is based upon a motivating activity, not about the child).
5.Frequent and short interventions. 6.Information to parents and teachers on how to communicate with children with SM
Intervention Type
Behavioral
Intervention Name(s)
Guidance on defocused communication
Intervention Description
Guidance and supervision to teachers working with the children with SM. Frequency: Twice during three months
Primary Outcome Measure Information:
Title
School version of the Selective Mutism Questionnaire (SSQ)
Time Frame
at 3, 6, 12 months
Secondary Outcome Measure Information:
Title
Clinical Global Impression Scale (CGI)
Time Frame
at 3, 6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children from Eastern & Southern Norway will be included if they fulfill the diagnostic criteria for SM
Exclusion Criteria:
Children with SM and mental retardation with IQ below 50.
Children with SM and psychosis or pervasive developmental disorders with the exception of Asperger syndrome and PDD Nos (DSM-IV)
Children with SM who receive an active treatment for SM in the CAMHS
Children with SM who are medicated for social anxiety.
Children with SM where the parents do not understand Norwegian.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Kristensen, MD, PhD
Organizational Affiliation
Regional Centre for 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
0405
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
29357099
Citation
Oerbeck B, Overgaard KR, Stein MB, Pripp AH, Kristensen H. Treatment of selective mutism: a 5-year follow-up study. Eur Child Adolesc Psychiatry. 2018 Aug;27(8):997-1009. doi: 10.1007/s00787-018-1110-7. Epub 2018 Jan 22.
Results Reference
derived
PubMed Identifier
25267381
Citation
Oerbeck B, Stein MB, Pripp AH, Kristensen H. Selective mutism: follow-up study 1 year after end of treatment. Eur Child Adolesc Psychiatry. 2015 Jul;24(7):757-66. doi: 10.1007/s00787-014-0620-1. Epub 2014 Sep 30.
Results Reference
derived
PubMed Identifier
32878377
Citation
Oerbeck B, Stein MB, Wentzel-Larsen T, Langsrud O, Kristensen H. A randomized controlled trial of a home and school-based intervention for selective mutism - defocused communication and behavioural techniques. Child Adolesc Ment Health. 2014 Sep;19(3):192-198. doi: 10.1111/camh.12045. Epub 2013 Oct 26.
Results Reference
derived
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Randomised Controlled Treatment Study of Selective Mutism
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