Selective Mutism Clinical Trial
Official title:
Integrated Behavioral Treatment for Selective Mutism
This study will determine the effectiveness of integrated behavior therapy in treating children with selective mutism.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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