Integrated Behavioral Therapy for Treating Children With Selective Mutism

Selective Mutism Clinical Trial

Official title:

Integrated Behavioral Treatment for Selective Mutism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458198
• Other study ID #: R34MH070938
• Secondary ID: R34MH070938DDTR
• Status: Completed
• Phase: N/A
• First received: April 5, 2007
• Last updated: November 23, 2016
• Start date: January 2006
• Est. completion date: June 2009

Study information

• Verified date: November 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Mutism
• Selective Mutism

Intervention

Behavioral:
• Integrated behavioral therapy (BT)
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.

Locations

Country	Name	City	State
United States	300 UCLA Medical Plaza	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Selective Mutism Questionnaire		Measured at Weeks 8, 12, 24, and 36	No
Primary	Anxiety Disorders Interview Schedule (ADIS) Severity Rating		Measured at Weeks 8, 12, 24, and 36	No
Primary	Clinical Global Impression		Measured at Weeks 8, 12, 24, and 36	No
Secondary	Strong Narrative Assessment Procedure		Measured at Weeks 8, 12, 24, and 36	No