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Completed

NCT Number: NCT03612102

Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

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.

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Key information

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University

Miami, Florida, 33199, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Clinical Global Impressions Scales - Improvement (CGI-I)

    Time frame: 5 minutes

    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").

Secondary outcomes

  1. Anxiety Disorders Interview Schedule for Children (ADIS)

    Time frame: 2 hours

    The 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.

  2. Selective Mutism Questionnaire (SMQ)

    Time frame: 10 minutes

    The 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.

  3. Children's Global Assessment Scale (CGAS)

    Time frame: 5 minutes

    The 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.

  4. Child Behavior Checklist (CBCL)

    Time frame: 30 minutes

    The 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.

  5. School Speech Questionnaire (SSQ)

    Time frame: 5 minutes

    The 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.

  6. Impairment Rating Scale (IRS)

    Time frame: 8 minutes

    The 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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • American Psychological Association (APA)
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2018
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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