Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

Selective Mutism Clinical Trial

Official title:

Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612102
• Other study ID #: 800008139
• Status: Completed
• Phase: N/A
• Start date: February 11, 2017
• Est. completion date: December 14, 2017

Study information

• Verified date: August 2018
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Mutism
• Selective Mutism

Intervention

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.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida International University	American Psychological Association (APA) Division 53, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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