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Randomised Controlled Treatment Study of Selective Mutism

R

Regionsenter for barn og unges psykiske helse

Status and phase

Completed
Phase 2

Conditions

Selective Mutism

Treatments

Behavioral: Guidance on defocused communication
Behavioral: Stimulus fading procedures

Study type

Interventional

Funder types

Other

Identifiers

NCT01002196
Norwegian Research Council
190648/V50
RegionsenterBUP

Details and patient eligibility

About

Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk.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

Enrollment

24 patients

Sex

All

Ages

3 to 9 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

24 participants in 2 patient groups

stimulus fading procedures
Experimental group
Treatment:
Behavioral: Guidance on defocused communication
Behavioral: Stimulus fading procedures
guidance of defocused communication
Active Comparator group
Treatment:
Behavioral: Guidance on defocused communication

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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