Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

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.

Study Overview

• Status: Completed
• Conditions: Selective Mutism
• Intervention / Treatment: Behavioral: Intensive Group Behavioral Treatment (IGBT)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • Florida International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; The treatment consists of a 5-day intensive group behavioral treatment program (IGBT)	Behavioral: Intensive Group Behavioral Treatment (IGBT); 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.
No Intervention: Waitlist; 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?

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

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: National Institute of Mental Health (NIMH); American Psychological Association (APA)

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2017
• Primary Completion (Actual): December 14, 2017
• Study Completion (Actual): December 14, 2017

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Treatment; Anxiety; CBT; Group Treatment; Selective Mutism; Intensive Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Speech Disorders; Mutism
• Other Study ID Numbers: 800008139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No