Randomised Controlled Treatment Study of Selective Mutism

June 19, 2014 updated by: Hanne Kristensen, Regionsenter for barn og unges psykiske helse

How to Help When Silence is Not Golden A RCT Study of Selective Mutism

Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk.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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0405
        • Centre for Child and Adolescent Mental Health, Eastern and Southern Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
School version of the Selective Mutism Questionnaire (SSQ)
Time Frame: at 3, 6, 12 months
at 3, 6, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression Scale (CGI)
Time Frame: at 3, 6, 12 months
at 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regionsenter for barn og unges psykiske helse

Collaborators

The Research Council of Norway

Investigators

  • Principal Investigator: Hanne Kristensen, MD, PhD, Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RegionsenterBUP
  • 190648/V50
  • Norwegian Research Council

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.

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