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Randomised Controlled Treatment Study of Selective Mutism

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ClinicalTrials.gov Identifier: NCT01002196
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : June 20, 2014
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Hanne Kristensen, Regionsenter for barn og unges psykiske helse

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Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk.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.

Condition or disease Intervention/treatment Phase
Selective Mutism Behavioral: Stimulus fading procedures Behavioral: Guidance on defocused communication Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: How to Help When Silence is Not Golden A RCT Study of Selective Mutism
Study Start Date : June 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: stimulus fading procedures Behavioral: Stimulus fading procedures

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

Other Names:
  • stimulus fading technique
  • defocused communication

Behavioral: Guidance on defocused communication
Guidance and supervision to teachers working with the children with SM. Frequency: Twice during three months

Active Comparator: guidance of defocused communication Behavioral: Guidance on defocused communication
Guidance and supervision to teachers working with the children with SM. Frequency: Twice during three months




Primary Outcome Measures :
  1. School version of the Selective Mutism Questionnaire (SSQ) [ Time Frame: at 3, 6, 12 months ]

Secondary Outcome Measures :
  1. Clinical Global Impression Scale (CGI) [ Time Frame: at 3, 6, 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002196


Locations
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Norway
Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
Oslo, Norway, 0405
Sponsors and Collaborators
Regionsenter for barn og unges psykiske helse
The Research Council of Norway
Investigators
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Principal Investigator: Hanne Kristensen, MD, PhD Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hanne Kristensen, Director Section for Clinical Research, Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier: NCT01002196     History of Changes
Other Study ID Numbers: RegionsenterBUP
190648/V50
Norwegian Research Council
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014

Keywords provided by Hanne Kristensen, Regionsenter for barn og unges psykiske helse:
Selective Mutism
Intervention

Additional relevant MeSH terms:
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Mutism
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders