Integrated Behavioral Therapy for Treating Children With Selective Mutism - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00458198

Purpose

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

Condition	Intervention
Selective Mutism	Behavioral: Integrated behavioral therapy (BT)

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Integrated Behavioral Treatment for Selective Mutism

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Selective Mutism Questionnaire [ Time Frame: Measured at Weeks 8, 12, 24, and 36 ] [ Designated as safety issue: No ]
Anxiety Disorders Interview Schedule (ADIS) Severity Rating [ Time Frame: Measured at Weeks 8, 12, 24, and 36 ] [ Designated as safety issue: No ]
Clinical Global Impression [ Time Frame: Measured at Weeks 8, 12, 24, and 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Strong Narrative Assessment Procedure [ Time Frame: Measured at Weeks 8, 12, 24, and 36 ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	January 2006
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive integrated behavioral therapy	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.
2: Active Comparator Participants will receive integrated behavioral therapy after a 12-week waitlist period	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.

Arms

Assigned Interventions

1: Experimental

Participants will receive integrated behavioral therapy

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.

2: Active Comparator

Participants will receive integrated behavioral therapy after a 12-week waitlist period

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.

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.

Eligibility

Ages Eligible for Study:	4 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458198

Locations

United States, California
300 UCLA Medical Plaza
Los Angeles, California, United States, 90095

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

R. Lindsey Bergman, PhD

Semel Institute for Neuroscience & Human Behavior, Univeristy of California Los Angeles (UCLA)

More Information

Responsible Party:	UCLA Department of Psychiatry ( R. Lindsey Bergman, PhD; Associate Director UCLA Childhood OCD, Anxiety, and Tic Disorders Program )
Study ID Numbers:	R34 MH70938, DDTR B3-PDX
Study First Received:	April 5, 2007
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00458198
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Selective Mutism

Study placed in the following topic categories:

Signs and Symptoms
Speech Disorders
Mental Disorders
Mutism
Mental Disorders Diagnosed in Childhood

Elective mutism
Neurologic Manifestations
Language Disorders
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009