Integrated Behavioral Therapy for Treating Children With Selective Mutism

NCT00458198 | Completed

• 2 other identifiers: R34MH070938DDTR B3-PDX
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Selective Mutism

Keywords

Selective Mutism

Outcome Measures

Primary Outcomes (3)

• Selective Mutism Questionnaire

  Measured at Weeks 8, 12, 24, and 36

• Anxiety Disorders Interview Schedule (ADIS) Severity Rating

  Measured at Weeks 8, 12, 24, and 36

• Clinical Global Impression

  Measured at Weeks 8, 12, 24, and 36

Secondary Outcomes (1)

• Strong Narrative Assessment Procedure

  Measured at Weeks 8, 12, 24, and 36

Study Arms (2)

1

EXPERIMENTAL

Participants will receive integrated behavioral therapy

Behavioral: Integrated behavioral therapy (BT)

2

ACTIVE COMPARATOR

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

Behavioral: Integrated behavioral therapy (BT)

Interventions

Integrated behavioral therapy (BT) BEHAVIORAL

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.

1; 2

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

300 UCLA Medical Plaza

Los Angeles, California, 90095, United States

Location

Related 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. Epub 2013 Jul 16.

  PMID: 23933108 RESULT

MeSH Terms

Conditions

Mutism

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• R. Lindsey Bergman, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 9, 2007
• Study Start: January 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2009
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

US (1)