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Clinical Trial Summary

This study will determine the effectiveness of integrated behavior therapy in treating children with selective mutism.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00458198
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase N/A
Start date January 2006
Completion date June 2009

See also
  Status Clinical Trial Phase
Completed NCT02554929 - Treatment of Social Anxiety Disorder and Selective Mutism N/A
Completed NCT00554749 - What Treatment Works for Children With Selective Mutism? N/A
Completed NCT04585048 - The Efficacy of Integrated Behavioral Therapy for Selective Mutism N/A
Completed NCT04291638 - Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism N/A
Completed NCT01002196 - Randomised Controlled Treatment Study of Selective Mutism Phase 2
Completed NCT02009839 - Web-Based CBT Protocol for Treatment of Selective Mutism N/A
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Completed NCT02051192 - Brief Behavioral Treatment for Anxiety in Young Children Phase 1/Phase 2
Completed NCT05378711 - Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine Phase 2
Completed NCT03612102 - Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism N/A
Completed NCT04233905 - Factors Influencing Selective Mutism