Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety; Selective Mutism
• Intervention / Treatment: Drug: Fluoxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University Psychiatry Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female from seven to seventeen years of age at their last birthday
• Meet DSM-IV-TR criteria for selective mutism
• No history of medication treatment for selective mutism
• Child has an immediate biological family member who is diagnosed with an anxiety disorder or has experienced symptoms of an anxiety disorder at some point in time
• Child has received 10 weeks of an evidence-based psychosocial treatment
• Child has never had a negative reaction to a psychopharmacological medication
• Child exhibits symptoms of social anxiety

Exclusion Criteria:

• Child is diagnosed with a speech condition, mental retardation, pervasive developmental disorder, or schizophrenia
• Child is an English language learner or from a different culture than the culture predominately represented within his or her school
• Child is taking or has taken any kind of a psychopharmacological medication (e.g., SSRI, MAO-I, stimulant, etc.)
• Child has a medical illness that may be complicated through the use of a psychopharmacological treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fluoxetine; Children will receive an introductory dose and therapeutic dose of fluoxetine at various time points in the study. Onset of fluoxetine is determined by assignment to a pre-determined randomized treatment schedule.	Drug: Fluoxetine; Children will receive a placebo or fluoxetine at different times dependent upon random assignment to a treatment schedule.; Other Names: Prozac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Selective Mutism Questionnaire (Change Over 15 Weeks)	2 times per week for 15 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Multidimensional Anxiety Scale for Children - 2nd Edition (Change Over 15 Weeks)	2 times per week for 15 weeks
Direct Behavior Ratings - Parent (Change Over 15 Weeks)	Parent (3 times per week for 15 weeks); Teacher (5 times per week for 15 weeks)
Clinical Global Impression (Change Over 15 Weeks)	Parent and Teacher (2 times per week for 15 weeks); Psychiatrist (biweekly for 15 weeks)
Side Effects Form for Children and Adolescents - Adapted (Change Over 15 Weeks)	biweekly for 15 weeks
Parent - Young Mania Rating Scale (Change Over 15 Weeks)	2 times per week for 15 weeks
Treatment Evaluation Questionnaire - Parent	End of Study (after 15 weeks)

Other Outcome Measures

Outcome Measure	Time Frame
Treatment Integrity Form	Daily for 15 weeks

Collaborators and Investigators

• Sponsor: Michigan State University
• Investigators: Principal Investigator: Jed Magen, DO, Michigan State University; Principal Investigator: John Carlson, PhD, Michigan State University; Principal Investigator: Justin Barterian, MA, Michigan State University; Principal Investigator: Joel Sanchez, MD, Michigan State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): May 30, 2015
• Study Completion (ACTUAL): May 30, 2015

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (ACTUAL): May 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Adolescents; Children; Social Anxiety; Selective Mutism
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Speech Disorders; Mutism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: 13-718F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO