FLUOXETINE FOR THE TREATMENT OF SELECTIVE MUTISM WITH ELEVATED SOCIAL ANXIETY SYMPTOMS: A NONCONCURRENT MULTIPLE BASELINE DESIGN ACROSS FIVE CASES By Justin A. Barterian A DISSERTATION Submitted to Michigan State University in partial fulfillment of the requirements for the degree of School Psychology – Doctor of Philosophy 2015 ABSTRACT FLUOXETINE FOR THE TREATMENT OF SELECTIVE MUTISM WITH ELEVATED SOCIAL ANXIETY SYMPTOMS: A NONCONCURRENT MULTIPLE BASELINE DESIGN ACROSS FIVE CASES By Justin A. Barterian Selective mutism is a debilitating disorder with academic and social consequences, yet little research is available regarding psychopharmacological interventions (Carlson et al., 2008). This dissertation study examined the utility of fluoxetine (Prozac) for the treatment of five children, ages 5 to 14, diagnosed with selective mutism, who also demonstrated elevated levels of social anxiety symptomology. A non-concurrent multiple-baseline design with a single-blind placebo-controlled procedure was used to examine treatment outcomes. Effectiveness was evaluated by a multi-gate analysis process, including: a) visual analysis (Kratochwill et al., 2010); b) the Wampold and Worsham (1986) randomization test; and c) the Kendall’s Tau + Mann-Whitney U (Tau-U; Parker, Vannest, Davis, & Sauber, 2011) effect size calculation. Multiple methods of assessment including Direct Behavior Ratings (DBR; Chafouleas, Riley- Tillman, & Christ, 2009) and standardized measures [e.g., the Multidimensional Anxiety Scale for Children – Second Edition (MASC-2; March, 2012)] were used. Information regarding adverse effects with an emphasis on behavioral disinhibition and ratings of parental acceptance of the intervention were also gathered. Visual analysis of all five cases indicated fluoxetine did not demonstrate utility for the reduction of social anxiety symptoms and was ineffective in increasing spontaneous speech. However, as predicted a significant increase in responsive speech with unfamiliar adults (p = .03; Tau-U: .44, p < .01) was noted. Two of the five children experienced some acute occurrences of minor behavioral disinhibition, but did not experience any other side effects during the course of treatment. Behavioral disinhibition did not correspond to changes in social anxiety symptoms, responsive speech, or spontaneous speech. Parents found the use of fluoxetine for the treatment of selective mutism highly acceptable. Copyright by JUSTIN A. BARTERIAN 2015 ACKNOWLEDGEMENTS I am indebted to many who supported me throughout my graduate studies and the completion of this dissertation project. First, I am grateful for the guidance of my dissertation chair, Dr. John S. Carlson, who continually pushed me to be better with high expectations, patience, and encouragement. I am appreciative of the collaboration of Dr. Joel Sanchez and his willingness to be the psychiatrist on this project. This study could not have been completed without the collaboration of the professionals at the Michigan State University Psychiatry Clinic, especially Dr. Christopher Giuliano. Further, this project substantially benefitted from the support of my dissertation committee members, Drs. Jed Magen, Sara Witmer, and Evelyn Oka, who helped shape the ideas proposed at the beginning of this process. Additionally, I am thankful for the time and effort provided by my project assistants Allison Siroky, Brittany Mash, Marianne Clinton, and Elizabeth Snyder. This study was funded by a generous grant from the MSU School Psychology Program and a Dissertation Completion Fellowship provided by the Department of Counseling, Educational Psychology, and Special Education. I could not have made it this far without the sacrifice and support of my parents, Anthony and Michelle, as well as the support of other family members such as my brother Jonathon, my grandmother Eleanor, my Aunt Debra and those I have lost during my graduate studies: my grandparents Joseph and Rosina. I am forever grateful for the humor and camaraderie provided by the lifelong friends and colleagues I made during my time at MSU, who were excellent examples of working hard and having fun in the process. Finally, I would like to dedicate this paper to my fiancé, Alicia Spangler, whose unwavering support helped me persist and bring this paper to completion. I look forward to everything that comes next for us. v TABLE OF CONTENTS LIST OF TABLES ..........................................................................................................................x LIST OF FIGURES ..................................................................................................................... xii CHAPTER 1 ....................................................................................................................................1 INTRODUCTION ..........................................................................................................................1 CHAPTER 2 ....................................................................................................................................6 LITERATURE REVIEW ................................................................................................................6 Selective Mutism ........................................................................................................................6 Diagnostic criteria of selective mutism ...............................................................................6 Associated features .............................................................................................................7 Differential diagnosis ..........................................................................................................9 Prevalence rates ................................................................................................................11 Demographic characteristics .............................................................................................11 Prognosis ...........................................................................................................................12 Etiology of selective mutism ............................................................................................12 A joint biopsychosocial framework of selective mutism and social anxiety disorder .....................................................................................................12 Biological factors of selective mutism and social anxiety ........................13 Psychosocial factors of selective mutism and social anxiety ....................15 Pediatric Psychopharmacology and Selective Mutism .............................................................16 Ethics in pediatric psychopharmacology research and practice .......................................17 Selective Serotonin Reuptake Inhibitors ...................................................................................18 The intended effect of SSRIs .............................................................................................20 Side effects associated with SSRIs ....................................................................................22 Intended effects of SSRIs vs. behavioral disinhibition related to selective mutism................................................................................................................................24 Current Evidence-Base of Selective Mutism Treatments ........................................................25 Psychosocial treatments for selective mutism ..................................................................25 Behavioral and cognitive-behavioral therapy .......................................................25 Selective serotonin reuptake inhibitors for the treatment of selective mutism .................26 Fluoxetine .............................................................................................................26 Quasi-experimental studies .......................................................................27 Case studies ...............................................................................................28 Critical summary of fluoxetine studies ......................................................30 Sertraline ...............................................................................................................30 Critical summary of sertraline studies .......................................................32 Paroxetine and fluvoxamine .................................................................................32 Critical summary of fluvoxamine and paroxetine studies .........................33 Single-Case Research Design ....................................................................................................33 Rationale for single-case design within selective mutism research ...................................33 vi Multiple-baseline designs ..................................................................................................36 Concurrent versus nonconcurrent multiple baseline designs .................................37 Visual analysis of single-case design data .............................................................39 Quantitative analysis of single-case design data ....................................................41 Randomization tests for the analysis of single-case design data ...............41 Effect size calculations for single-case design data ...................................43 Single-case design in selective mutism psychopharmacology studies ..............................44 Current Study ............................................................................................................................45 Research questions and hypotheses ..................................................................................46 CHAPTER 3 ..................................................................................................................................54 METHODS ....................................................................................................................................54 Participants ................................................................................................................................54 Measures ...................................................................................................................................59 Social anxiety ....................................................................................................................60 Direct behavior rating (DBR): Social engagement ...............................................60 Multidimensional anxiety scale for children – 2nd edition (MASC-2) -Social anxiety scale (SAS) ...............................................................................................62 Clinical global impressions (CGI): Anxiety/Shyness ...........................................63 Frequency of speech .........................................................................................................64 Direct behavior rating (DBR): Speech ..................................................................64 Selective mutism questionnaire (SMQ) ................................................................64 Clinical global impressions (CGI): Mutism ..........................................................65 Adverse events ..................................................................................................................65 Clinical global impressions (CGI): Side effects ...................................................65 Side effects form for children and adolescents (SEFCA) ......................................66 Behavioral disinhibition ....................................................................................................67 Parent version of the young mania rating scale (P-YMRS) ..................................67 Treatment acceptability .....................................................................................................68 Treatment evaluation questionnaire – acceptability scale (TEQ-P) ......................68 Medication compliance measure ...........................................................................69 End of study form .................................................................................................69 Procedures ................................................................................................................................69 Project personnel ...............................................................................................................70 Project coordinator ................................................................................................70 Project assistants ....................................................................................................71 Study psychiatrist ...................................................................................................71 Training .............................................................................................................................71 Study psychiatrist ..................................................................................................71 Project assistants ....................................................................................................72 Teachers .................................................................................................................72 Parents ...................................................................................................................73 Study Phases ..............................................................................................................................73 Project overview ...............................................................................................................73 Inclusion and exclusion criteria .........................................................................................74 Screening ...........................................................................................................................75 vii Consent and assent procedures .........................................................................................76 Baseline .............................................................................................................................76 Treatment ..........................................................................................................................78 End of treatment phase.......................................................................................................79 Experimental Design ................................................................................................................79 Data Analysis ............................................................................................................................80 Multi-gate analysis ............................................................................................................80 Question one ......................................................................................................................83 Question two ......................................................................................................................83 Question three ....................................................................................................................83 Question four .....................................................................................................................84 Question five ......................................................................................................................84 CHAPTER 4 ..................................................................................................................................88 RESULTS ......................................................................................................................................88 Question One .............................................................................................................................88 Question Two .............................................................................................................................90 Question Three ...........................................................................................................................91 Question Four.............................................................................................................................93 Question Five .............................................................................................................................96 Individual Improvements ...........................................................................................................98 CHAPTER 5 ................................................................................................................................100 DISCUSSION ..............................................................................................................................100 Fluoxetine Treatment for Associated Social Anxiety ..............................................................100 Fluoxetine Treatment for Speaking Behaviors .......................................................................102 Behavioral Disinhibition and Other Adverse Events ...............................................................105 Medication Compliance ...........................................................................................................108 Treatment Acceptability...........................................................................................................109 Implications for Research ........................................................................................................110 Limitations ...............................................................................................................................111 APPENDICES .............................................................................................................................115 Appendix A: Young Mania Rating Scale – Parent Version (Adapted) ..................................116 Appendix B: Letter to School Psychologists, Private Practitioners, and Early Childhood Mental Health Workers ....................................................................118 Appendix C: Recruitment Flyer ...............................................................................................119 Appendix D: Letter to Principals .............................................................................................120 Appendix E: Inclusion and Exclusion Criteria ........................................................................121 Appendix F: Correlation Matrix ..............................................................................................122 Appendix G: Medication Log ..................................................................................................123 Appendix H: Early Exit Form ..................................................................................................124 Appendix I: End of Study Form...............................................................................................125 Appendix J: Direct Behavior Rating Forms – Teacher and Parent ..........................................126 Appendix K: Multidimensional Anxiety Scale for Children – 2nd Edition: Social Anxiety Scale .....................................................................................................130 viii Appendix L: Clinical Global Impressions (Severity and Change) – Clinician, Parent, Teacher ...................................................................................................131 Appendix M: Selective Mutism Questionnaire........................................................................142 Appendix N: Adapted Side Effects for Children and Adolescents (SEFCA) .........................145 Appendix O: Answers on the Parent-Mania Rating Scale that May Indicate Behavioral Disinhibition as a Result of Fluoxetine Treatment ...........................146 Appendix P: Treatment Evaluation Questionnaire, parent version .........................................148 Appendix Q: Consent Forms and Assent Procedures for Participation (Parent, Teacher, Child) .................................................................................................149 Appendix R: Medical, Developmental, Psychosocial, Family, Substance Abuse, and Legal History Form – MSU Psychiatry Clinic ............................................161 Appendix S: Consent for Release of Confidential Medical, Treatment, and School Records ...............................................................................................................169 Appendix T: History of Treatment Form for Previous Treating Professional .........................170 Appendix U: Physical Exam ....................................................................................................172 Appendix V: Visual Analysis Decision Tree ...........................................................................173 REFERENCES ............................................................................................................................175 ix LIST OF TABLES Table 1 DSM-5 Criteria for Selective Mutism ............................................................... ...7 Table 2 FDA Approval of SSRIs for Anxiety Disorders in Children and Adolescents ......................................................................................................... 19 Table 3 Published Case Studies on Fluoxetine Treatment for Selective Mutism ............ 29 Table 4 Rationale for Single-Case Designs in Psychopharmacology Studies with Children Diagnosed with SM............................................................................. 34 Table 5 What Works Clearinghouse Requirements to Be Rated “Meets Evidence Standards” for SCD........................................................................................... 36 Table 6 Research Questions, Hypotheses, and Planned Assessment Procedures ........... 48 Table 7 Demographic Characteristics and Baseline/Intervention Ratings for Six Participants ........................................................................................................ 56 Table 8 Pre-Treatment, During Treatment, and Post-Treatment Ratings by Treatment Schedule ........................................................................................... 58 Table 9 Assessments Planned for Each Phase ................................................................ 60 Table 10 Randomized Multiple Baseline Design Baseline and Treatment Schedule ........................................................................................................... 78 Table 11 Percent Completion Rate of Data Forms per Observer .................................... 82 Table 12 Means of Social Anxiety Symptom on Outcome Measure Across Baseline and Treatment Phases ........................................................................ 85 Table 13 Direct Behavior Ratings – Mean Speaking Behaviors Across Baseline and Treatment Phases ....................................................................................... 86 Table 14 Means of Supplementary Selective Mutism Outcome Measures Across Baseline and Treatment Phases ......................................................................... 87 Table 15 CGI – Means of Global Side Effect Ratings..................................................... 93 Table 16 Answers on the TEQ-P Across Participants ..................................................... 97 Table 17 Medication Compliance Rates per Phase .......................................................... 98 x
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