Integrated Behavioral Therapy for Treating Children With Selective Mutism
Primary Purpose
Selective Mutism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated behavioral therapy (BT)
Sponsored by
About this trial
This is an interventional treatment trial for Selective Mutism focused on measuring Selective Mutism
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of selective mutism
- Score of less than 60 on the Childrens Global Assessment Scale (CGAS)
- Has lived continuously with a primary caretaker who has known the child well for at least 6 months prior to study entry and is legally able to sign the consent form
Exclusion Criteria:
- Diagnosis of any of the following psychiatric disorders: bipolar disorder, pervasive developmental disorder (e.g., Asperger's, autism), mental retardation, or psychotic disorder
- Possibility that a communication disorder may account for the selective mutism
- Current use of or a clinical indication for use of psychotropic medication (youth entering study on a stable psychostimulant regimen for ADHD will not be excluded)
- History of unsuccessful treatment with cognitive behavioral therapy for anxiety that occurred within 2 years prior to study entry
- Any major neurological disorder or major medical illness that may prevent study participation
- Child and/or parent is not English-speaking and is unable to complete measures or treatment without the assistance of a dedicated translator
- Child is not currently attending school (including pre-school), day camp, or other structured daily activity, or has missed more than 50% of school days in the 2 months prior to study entry
- Child's primary teacher is unwilling or unable to participate in the treatment plan
Sites / Locations
- 300 UCLA Medical Plaza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive integrated behavioral therapy
Participants will receive integrated behavioral therapy after a 12-week waitlist period
Outcomes
Primary Outcome Measures
Selective Mutism Questionnaire
Anxiety Disorders Interview Schedule (ADIS) Severity Rating
Clinical Global Impression
Secondary Outcome Measures
Strong Narrative Assessment Procedure
Full Information
NCT ID
NCT00458198
First Posted
April 5, 2007
Last Updated
November 23, 2016
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00458198
Brief Title
Integrated Behavioral Therapy for Treating Children With Selective Mutism
Official Title
Integrated Behavioral Treatment for Selective Mutism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
This study will determine the effectiveness of integrated behavior therapy in treating children with selective mutism.
Detailed Description
Selective mutism (SM) is a childhood behavior disorder that interferes with social and educational development. It is characterized by a persistent failure to speak in specific social situations, despite being able to speak in other situations. Children with SM typically speak when they are at home with immediate family, but fail to speak in other settings. Behavior therapy (BT), commonly used for treating anxiety disorders and phobias, is a type of treatment that uses training and desensitization methods to help patients become more comfortable in situations that cause anxiety. Based on available evidence, integrated BT, which involves parents, teachers, and the therapist, may be an effective treatment for SM. This study will determine the effectiveness of integrated BT in treating children with selective mutism.
Following a diagnostic assessment to determine eligibility, participants in this single-blind study will be randomly assigned to receive BT either immediately upon study entry or after a 3-month waiting period. BT will consist of 20 1-hour treatment sessions over 6 months. In BT, children will practice speaking to people with whom it has been difficult to speak in the past. Parents, teachers, and children will be taught about anxiety related to SM, setting treatment goals, monitoring anxiety, learning skills to relax, and gradually entering situations that may trigger anxiety. These skills will be practiced during treatment sessions, in school with other children and teachers, and at home on a daily basis. Both parents and teachers will record activities that children have been able to accomplish. In addition, participants will attend study visits at Weeks 8, 12, and 24 for assessments of outcomes.
Participants who are assigned to the waitlist group will not receive treatment during their first 3 months in the study. They will attend study visits at Weeks 8 and 12 to assess any improvement in symptoms. Participants whose symptoms do not improve by the end of the 3-month period may either stop participation or receive 6 months of BT.
All participants will attend one 2- to 3-hour follow-up visit 3 months post-treatment. This visit will include interviews and questionnaires about SM symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selective Mutism
Keywords
Selective Mutism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive integrated behavioral therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive integrated behavioral therapy after a 12-week waitlist period
Intervention Type
Behavioral
Intervention Name(s)
Integrated behavioral therapy (BT)
Intervention Description
Participants in the BT condition will receive twenty 60-minute sessions over 24 weeks. Sessions will focus on graduated exposure to new speaking situations as the primary agent of anxiety reduction. Behavioral procedures will include systematic desensitization, shaping, and self-modeling procedures. Although a variety of exposure exercises will be routinely conducted in-session, any behavioral assignments will take place outside of session. Behavioral exercises will be implemented, as needed, in a modular fashion. For example, exercises may focus on speaking in-session to therapist, either at school or at home with others present. The therapist will be primarily responsible for developing the exposure parameters, but collaboration of parent, teacher, child will be emphasized increasingly over time. Reinforcement for attempts to complete assignments (contingency management program) will occur throughout treatment.
Primary Outcome Measure Information:
Title
Selective Mutism Questionnaire
Time Frame
Measured at Weeks 8, 12, 24, and 36
Title
Anxiety Disorders Interview Schedule (ADIS) Severity Rating
Time Frame
Measured at Weeks 8, 12, 24, and 36
Title
Clinical Global Impression
Time Frame
Measured at Weeks 8, 12, 24, and 36
Secondary Outcome Measure Information:
Title
Strong Narrative Assessment Procedure
Time Frame
Measured at Weeks 8, 12, 24, and 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of selective mutism
Score of less than 60 on the Childrens Global Assessment Scale (CGAS)
Has lived continuously with a primary caretaker who has known the child well for at least 6 months prior to study entry and is legally able to sign the consent form
Exclusion Criteria:
Diagnosis of any of the following psychiatric disorders: bipolar disorder, pervasive developmental disorder (e.g., Asperger's, autism), mental retardation, or psychotic disorder
Possibility that a communication disorder may account for the selective mutism
Current use of or a clinical indication for use of psychotropic medication (youth entering study on a stable psychostimulant regimen for ADHD will not be excluded)
History of unsuccessful treatment with cognitive behavioral therapy for anxiety that occurred within 2 years prior to study entry
Any major neurological disorder or major medical illness that may prevent study participation
Child and/or parent is not English-speaking and is unable to complete measures or treatment without the assistance of a dedicated translator
Child is not currently attending school (including pre-school), day camp, or other structured daily activity, or has missed more than 50% of school days in the 2 months prior to study entry
Child's primary teacher is unwilling or unable to participate in the treatment plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Lindsey Bergman, PhD
Organizational Affiliation
Semel Institute for Neuroscience & Human Behavior, Univeristy of California Los Angeles (UCLA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
300 UCLA Medical Plaza
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23933108
Citation
Bergman RL, Gonzalez A, Piacentini J, Keller ML. Integrated Behavior Therapy for Selective Mutism: a randomized controlled pilot study. Behav Res Ther. 2013 Oct;51(10):680-9. doi: 10.1016/j.brat.2013.07.003. Epub 2013 Jul 16.
Results Reference
result
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Integrated Behavioral Therapy for Treating Children With Selective Mutism
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