Randomised Controlled Treatment Study of Selective Mutism

Selective Mutism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002196
• Other study ID #: RegionsenterBUP
• Secondary ID: 190648/V50Norweg
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2009
• Last updated: June 19, 2014
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2014
• Source: Regionsenter for barn og unges psykiske helse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

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Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 9 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mutism
• Selective Mutism

Intervention

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

Locations

Country	Name	City	State
Norway	Centre for Child and Adolescent Mental Health, Eastern and Southern Norway	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Regionsenter for barn og unges psykiske helse	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	School version of the Selective Mutism Questionnaire (SSQ)		at 3, 6, 12 months	No
Secondary	Clinical Global Impression Scale (CGI)		at 3, 6, 12 months	No