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Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

Primary Purpose

Selective Mutism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Group Behavioral Treatment (IGBT)
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Selective Mutism focused on measuring Selective Mutism, Treatment, Anxiety, Intensive Treatment, CBT, Group Treatment

Eligibility Criteria

5 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment

Waitlist

Arm Description

The treatment consists of a 5-day intensive group behavioral treatment program (IGBT)

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.

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 26, 2018
Last Updated
August 13, 2018
Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH), American Psychological Association (APA)
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1. Study Identification

Unique Protocol Identification Number
NCT03612102
Brief Title
Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism
Official Title
Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 11, 2017 (Actual)
Primary Completion Date
December 14, 2017 (Actual)
Study Completion Date
December 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH), American Psychological Association (APA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selective Mutism
Keywords
Selective Mutism, Treatment, Anxiety, Intensive Treatment, CBT, Group Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
"Independent evaluators" assigned to assess outcomes will be masked to whether or not families participated in IGBT or were at the end of their waitlist period.
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
The treatment consists of a 5-day intensive group behavioral treatment program (IGBT)
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Group Behavioral Treatment (IGBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Global Impressions Scales - Improvement (CGI-I)
Description
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").
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for Children (ADIS)
Description
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.
Time Frame
2 hours
Title
Selective Mutism Questionnaire (SMQ)
Description
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.
Time Frame
10 minutes
Title
Children's Global Assessment Scale (CGAS)
Description
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.
Time Frame
5 minutes
Title
Child Behavior Checklist (CBCL)
Description
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.
Time Frame
30 minutes
Title
School Speech Questionnaire (SSQ)
Description
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.
Time Frame
5 minutes
Title
Impairment Rating Scale (IRS)
Description
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.
Time Frame
8 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

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