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Completed

NCT Number: NCT01002196

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Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk.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

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Key information

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre for Child and Adolescent Mental Health, Eastern and Southern Norway

Oslo, 0405, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stimulus fading procedures

Behavioral

Core elements : 1.Behavior techniques (BT's) are used to gradually master the anxiety ("stimulus fading" and reward).

  • 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

Guidance on defocused communication

Behavioral

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

Primary outcomes

  1. School version of the Selective Mutism Questionnaire (SSQ)

    Time frame: at 3, 6, 12 months

Secondary outcomes

  1. Clinical Global Impression Scale (CGI)

    Time frame: at 3, 6, 12 months

Sponsors and collaborators

Lead sponsor

Regionsenter for barn og unges psykiske helse

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2009
Registry last updated
Jun 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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