Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

NCT03612102 | Completed

• 1 other identifier: 800008139
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This goal of this study is to evaluate an intensive group behavioral treatment (IGBT) program for children with selective mutism, a low base-rate childhood anxiety disorder. 29 children between the ages of 5 and 9 will be randomly assigned to participate in a 5-day IGBT over the summer or to a waitlist control condition, with the opportunity to participate in IGBT 4 weeks later. All children that participate in treatment will be followed up 8 weeks into the following school year.

Conditions

Selective Mutism

Keywords

Selective Mutism; Treatment; Anxiety; Intensive Treatment; CBT; Group Treatment

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impressions Scales - Improvement (CGI-I)

  CGI-I is the most widely used clinician-rated measure of treatment-related changes in functioning (Guy \& Bonato, 1970) and will be completed by masked independent evaluators in the present study. The CGI-I rates clinical improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse").

  5 minutes

Secondary Outcomes (6)

• Anxiety Disorders Interview Schedule for Children (ADIS)

  2 hours

• Selective Mutism Questionnaire (SMQ)

  10 minutes

• Children's Global Assessment Scale (CGAS)

  5 minutes

• Child Behavior Checklist (CBCL)

  30 minutes

• School Speech Questionnaire (SSQ)

  5 minutes

Study Arms (2)

Treatment

ACTIVE COMPARATOR

The treatment consists of a 5-day intensive group behavioral treatment program (IGBT)

Behavioral: Intensive Group Behavioral Treatment (IGBT)

Waitlist

NO INTERVENTION

The waitlist consists of a 4-week waitlist period where parents will be provided with psychoeducational materials about their child's condition (i.e., selective mutism). After the 4-week waitlist period, families will be provided with the opportunity to participate in IGBT.

Interventions

Intensive Group Behavioral Treatment (IGBT) BEHAVIORAL

IGBT is a 5-day intensive treatment program, where cognitive behavioral therapy is provided to children and their parents delivered over 6-8 hours per day over the course of 5 days.

Treatment

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Meets diagnostic criteria for selective mutism
• Verbal with at least 1 parent or caregiver
• Child fluent in English

You may not qualify if:

• Any mental health difficulty significantly more impairing than selective mutism

Sponsors & Collaborators

• Florida International University: lead
• National Institute of Mental Health (NIMH): collaborator
• American Psychological Association (APA): collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Mutism; Anxiety Disorders

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: "Independent evaluators" assigned to assess outcomes will be masked to whether or not families participated in IGBT or were at the end of their waitlist period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Families of children with selective mutism will be randomly assigned to receive either immediate intensive group behavioral treatment (IGBT) or to a waitlist with psychoeducational materials, and then IGBT.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: February 11, 2017
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)