Clinical trial NCT01002196: Randomised Controlled Treatment Study of Selective Mutism
Official title: How to Help When Silence is Not Golden A RCT Study of Selective Mutism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Selective Mutism
Keywords: Selective Mutism
Intervention
Lead sponsor: Regionsenter for barn og unges psykiske helse
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2009-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk.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


Eligibility 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.

Primary outcomes:
measure: School version of the Selective Mutism Questionnaire (SSQ)
timeFrame: at 3, 6, 12 months
Secondary outcomes:
measure: Clinical Global Impression Scale (CGI)
timeFrame: at 3, 6, 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
Study officials:
affiliation: Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway
name: Hanne Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oerbeck B, Overgaard KR, Stein MB, Pripp AH, Kristensen H. Treatment of selective mutism: a 5-year follow-up study. Eur Child Adolesc Psychiatry. 2018 Aug;27(8):997-1009. doi: 10.1007/s00787-018-1110-7. Epub 2018 Jan 22.
citation: Oerbeck B, Stein MB, Pripp AH, Kristensen H. Selective mutism: follow-up study 1 year after end of treatment. Eur Child Adolesc Psychiatry. 2015 Jul;24(7):757-66. doi: 10.1007/s00787-014-0620-1. Epub 2014 Sep 30.
citation: Oerbeck B, Stein MB, Wentzel-Larsen T, Langsrud O, Kristensen H. A randomized controlled trial of a home and school-based intervention for selective mutism - defocused communication and behavioural techniques. Child Adolesc Ment Health. 2014 Sep;19(3):192-198. doi: 10.1111/camh.12045. Epub 2013 Oct 26.