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Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03612102
Enrollment
29
Registered
2018-08-02
Start date
2017-02-11
Completion date
2017-12-14
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selective Mutism

Keywords

Selective Mutism, Treatment, Anxiety, Intensive Treatment, CBT, Group Treatment

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.

Interventions

BEHAVIORALIntensive Group Behavioral Treatment (IGBT)

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
American Psychological Association (APA)
CollaboratorOTHER
Florida International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Any mental health difficulty significantly more impairing than selective mutism

Design outcomes

Primary

MeasureTime frameDescription
Clinical Global Impressions Scales - Improvement (CGI-I)5 minutesCGI-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).

Secondary

MeasureTime frameDescription
Selective Mutism Questionnaire (SMQ)10 minutesThe SMQ is a parent-report measure of selective mutism/verbal behaviors in various settings. Two subscales were used for the purpose of this study, the Social subscale (social scores are a sum of 5 items with scores ranging from 0-15) and the Home subscale (home scores are a sum of 6 items with scores ranging from 0-18). Lower scores indicate less verbal behavior, and higher scores indicate more verbal behavior.
Children's Global Assessment Scale (CGAS)5 minutesThe Children's Global Assessment Scale (CGAS; Shaffer et al., 1983) is a widely used measure of overall child disturbance, providing a clinician-rated index of functioning. Scores range from 0-100, with lower scores indicating greater functional impairments.
Anxiety Disorders Interview Schedule for Children (ADIS)2 hoursThe ADIS is is a semi-structured diagnostic interview that assesses child psychopathology in accordance with DSM criteria. From the ADIS, clinical severity ratings are generated by independent evaluators (IEs) to determine severity of selective mutism and social anxiety disorder. IE's also determine presence of diagnosis, which was also a main outcome.
School Speech Questionnaire (SSQ)5 minutesThe SSQ is a brief measure given to teachers to assess verbal behavior in the school setting. The SSQ generates a total score, which is a sum of 7 items. Scores range from 0-21, with lower scores indicating less verbal behavior, and higher scores indicating more verbal behavior.
Impairment Rating Scale (IRS)8 minutesThe IRS is a brief teacher-report scale of how much a child's problems are interfering with their social and academic functioning in the school setting. The IRS consists of 7 items, with 6 of the items being rated on a scale from 0-6, with higher scores being more indicative of a worst problem. The 6 items are summed to form a total score which ranges from 0 to 36, with higher scores indicating worse problems.
Child Behavior Checklist (CBCL)30 minutesThe CBCL is a parent-report general measure assessing multiple problems of childhood. Subscales are standardized by age and gender. The Anxiety Problems Subscale t-score will be used as an outcome measure for the purpose of this study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026