Clinical trial NCT05378711: Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine
Official title: Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Selective Mutism
Social Anxiety
Keywords: Selective Mutism
Social Anxiety
Children
Adolescents
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Selective Mutism Questionnaire (Change Over 15 Weeks)
timeFrame: 2 times per week for 15 weeks
Secondary outcomes:
measure: Multidimensional Anxiety Scale for Children - 2nd Edition (Change Over 15 Weeks)
timeFrame: 2 times per week for 15 weeks
measure: Direct Behavior Ratings - Parent (Change Over 15 Weeks)
timeFrame: Parent (3 times per week for 15 weeks); Teacher (5 times per week for 15 weeks)
measure: Clinical Global Impression (Change Over 15 Weeks)
timeFrame: Parent and Teacher (2 times per week for 15 weeks); Psychiatrist (biweekly for 15 weeks)
measure: Side Effects Form for Children and Adolescents - Adapted (Change Over 15 Weeks)
timeFrame: biweekly for 15 weeks
measure: Parent - Young Mania Rating Scale (Change Over 15 Weeks)
timeFrame: 2 times per week for 15 weeks
measure: Treatment Evaluation Questionnaire - Parent
timeFrame: End of Study (after 15 weeks)
Other outcomes:
measure: Treatment Integrity Form
timeFrame: Daily for 15 weeks
Locations:
city: East Lansing
country: United States
facility: Michigan State University Psychiatry Clinic
state: Michigan
Study officials:
affiliation: Michigan State University
name: Jed Magen, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: John Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Justin Barterian, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Joel Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References: