Randomised Controlled Treatment Study of Selective Mutism

NCT01002196 | Completed Phase 2

• 3 other identifiers: RegionsenterBUP190648/V50Norwegian Research Council
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk.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

Conditions

Selective Mutism

Keywords

Selective Mutism; Intervention

Outcome Measures

Primary Outcomes (1)

• School version of the Selective Mutism Questionnaire (SSQ)

  at 3, 6, 12 months

Secondary Outcomes (1)

• Clinical Global Impression Scale (CGI)

  at 3, 6, 12 months

Study Arms (2)

stimulus fading procedures

EXPERIMENTAL

Behavioral: Stimulus fading procedures; Behavioral: Guidance on defocused communication

guidance of defocused communication

ACTIVE COMPARATOR

Behavioral: Guidance on defocused communication

Interventions

Stimulus fading procedures BEHAVIORAL

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

Also known as: stimulus fading technique, defocused communication

stimulus fading procedures

Guidance on defocused communication BEHAVIORAL

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

guidance of defocused communication; stimulus fading procedures

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children from Eastern \& Southern Norway will be included if they fulfill the diagnostic criteria for SM

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regionsenter for barn og unges psykiske helse: lead
• The Research Council of Norway: collaborator

Study Sites (1)

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

Oslo, 0405, Norway

Location

Related Publications (3)

• 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.

  PMID: 32878377 DERIVED

• 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.

  PMID: 29357099 DERIVED

• 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.

  PMID: 25267381 DERIVED

MeSH Terms

Conditions

Mutism

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hanne Kristensen, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Section for Clinical Research

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

NO (1)