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

Sponsor

Michigan State University (Other)

Overall Status

Completed

CT.gov ID

NCT05378711

Collaborator

(none)

Enrollment

Location

Arm

16.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Selective Mutism Social Anxiety	Drug: Fluoxetine	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Double

Masking Description:

Participants serve as their own controls by being randomly assigned to switch from placebo to active medication at staggered start dates per single case design methodology.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

May 30, 2015

Actual Study Completion Date :

May 30, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Selective Mutism Questionnaire (Change Over 15 Weeks) [2 times per week for 15 weeks]

Secondary Outcome Measures

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

Treatment Integrity Form [Daily for 15 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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