Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

Study Overview
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Brief Summary
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This goal of this study is to evaluate an intensive group behavioral treatment (IGBT) program for children with selective mutism, a low base-rate childhood anxiety disorder. 29 children between the ages of 5 and 9 will be randomly assigned to participate in a 5-day IGBT over the summer or to a waitlist control condition, with the opportunity to participate in IGBT 4 weeks later. All children that participate in treatment will be followed up 8 weeks into the following school year.

Official Title
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Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

Conditions
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Selective Mutism

Intervention / Treatment
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* Behavioral: Intensive Group Behavioral Treatment (IGBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets diagnostic criteria for selective mutism Verbal with at least 1 parent or caregiver Child fluent in English Exclusion Criteria: Any mental health difficulty significantly more impairing than selective mutism

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Families of children with selective mutism will be randomly assigned to receive either immediate intensive group behavioral treatment (IGBT) or to a waitlist with psychoeducational materials, and then IGBT.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>The treatment consists of a 5-day intensive group behavioral treatment program (IGBT) | Behavioral: Intensive Group Behavioral Treatment (IGBT)<br>* IGBT is a 5-day intensive treatment program, where cognitive behavioral therapy is provided to children and their parents delivered over 6-8 hours per day over the course of 5 days.<br>|
| No Intervention: Waitlist<br>The waitlist consists of a 4-week waitlist period where parents will be provided with psychoeducational materials about their child's condition (i.e., selective mutism). After the 4-week waitlist period, families will be provided with the opportunity to participate in IGBT. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions Scales - Improvement (CGI-I) | CGI-I is the most widely used clinician-rated measure of treatment-related changes in functioning (Guy & Bonato, 1970) and will be completed by masked independent evaluators in the present study. The CGI-I rates clinical improvement on a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse). | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorders Interview Schedule for Children (ADIS) | The ADIS is is a semi-structured diagnostic interview that assesses child psychopathology in accordance with DSM criteria. From the ADIS, clinical severity ratings are generated by independent evaluators (IEs) to determine severity of selective mutism and social anxiety disorder. IE's also determine presence of diagnosis, which was also a main outcome. | 2 hours | 
| Selective Mutism Questionnaire (SMQ) | The SMQ is a parent-report measure of selective mutism/verbal behaviors in various settings. Two subscales were used for the purpose of this study, the Social subscale (social scores are a sum of 5 items with scores ranging from 0-15) and the Home subscale (home scores are a sum of 6 items with scores ranging from 0-18). Lower scores indicate less verbal behavior, and higher scores indicate more verbal behavior. | 10 minutes | 
| Children's Global Assessment Scale (CGAS) | The Children's Global Assessment Scale (CGAS; Shaffer et al., 1983) is a widely used measure of overall child disturbance, providing a clinician-rated index of functioning. Scores range from 0-100, with lower scores indicating greater functional impairments. | 5 minutes | 
| Child Behavior Checklist (CBCL) | The CBCL is a parent-report general measure assessing multiple problems of childhood. Subscales are standardized by age and gender. The Anxiety Problems Subscale t-score will be used as an outcome measure for the purpose of this study. | 30 minutes | 
| School Speech Questionnaire (SSQ) | The SSQ is a brief measure given to teachers to assess verbal behavior in the school setting. The SSQ generates a total score, which is a sum of 7 items. Scores range from 0-21, with lower scores indicating less verbal behavior, and higher scores indicating more verbal behavior. | 5 minutes | 
| Impairment Rating Scale (IRS) | The IRS is a brief teacher-report scale of how much a child's problems are interfering with their social and academic functioning in the school setting. The IRS consists of 7 items, with 6 of the items being rated on a scale from 0-6, with higher scores being more indicative of a worst problem. The 6 items are summed to form a total score which ranges from 0 to 36, with higher scores indicating worse problems. | 8 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group Treatment, Selective Mutism, Treatment, Anxiety, Intensive Treatment, CBT