Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine
Condition: Selective Mutism; Social Anxiety
MeSH terms: Mutism
Study type: Interventional
Phase: Phase 2

Summary: 
      The Department of Counseling, Educational Psychology, and Special Education and the
      Department of Psychiatry at Michigan State University have coordinated efforts to provide a
      diagnostic and treatment investigation for children, ages seven to eighteen, with Selective
      Mutism. The purpose of this study is to examine the utility of fluoxetine for the treatment
      of this debilitating disorder. Fluoxetine is expected to improve social anxiety and selective
      mutism symptomology.
    

Detailed description: 
      Children with selective mutism (SM) are at risk for current and continuing academic and
      socio-emotional difficulties. Unfortunately, this issue is complicated by the fact these
      children often respond poorly to psychosocial intervention. This leaves parents with the
      overwhelming decision to attempt a trial of medication regardless of the little available
      data on the evidence base of this approach. Despite the paucity of research, psychiatrists
      are prescribing fluoxetine for children with SM "off label", as the Food and Drug
      Administration (FDA) has yet to approve fluoxetine for this indication. This study blends the
      psychopharmacological expertise of psychiatrists with the mental health, systems, and
      psychological evaluation expertise of school psychologists to identify an appropriate
      psychopharmacological solution for children and adolescents with this debilitating disorder.
      To that end, this study will examine the utility of fluoxetine for the treatment of five
      children and adolescents, ages seven to eighteen, diagnosed with SM through the use of a
      non-concurrent multiple-baseline single-case design with a single-blind placebo-controlled
      procedure. Treatment effectiveness will be evaluated by visual analysis of the data, the
      Wampold and Worsham multiple-baseline design randomization test, and the Kendall's Tau +
      Mann-Whitney U effect size. Multiple methods of assessment including standardized measures,
      such as the Selective Mutism Questionnaire (SMQ), and behavior ratings, such as Direct
      Behavior Ratings (DBRs), will be used to gather baseline and treatment data. Multiple
      informants (i.e., parents, teachers, and psychiatrists) will provide information on treatment
      effect across settings (i.e., school and community). Information regarding adverse effects
      associated with fluoxetine treatment including a measure of behavioral disinhibition,
      parental acceptance of the fluoxetine intervention, and compliance with taking the medication
      will also be gathered.
    

Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention description(s): Children will receive a placebo or fluoxetine at different times dependent upon random assignment to a treatment schedule.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Selective Mutism; Social Anxiety; Children; Adolescents