Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism

Not Applicable

Completed

• Conditions: Selective Mutism

• Registration Number: NCT04291638
• Lead Sponsor: Florida International University

Brief Summary

This study sought to evaluate an innovative post-acute continuation/transition planning treatment strategy that leveraged an in-person intensive treatment followed by online, videoconferencing-based "booster" sessions for youth with selective mutism (SM). Twenty children between the ages of 4 and 10 and their caregivers were scheduled to participate in an in-person intensive group behavioral treatment (IGBT) for SM and subsequently randomized to receive either (a) six, biweekly, hour-long, videoconferencing-delivered booster sessions or (b) no additional treatment for 12 weeks. Due to COVID-19-related physical distancing restrictions, the study team was unable to provide in-person services. Thus, the clinical trial was converted to an open-trial design focused on evaluating remote treatment options (i.e., remotely delivered caregiver training sessions and/or a remotely delivered IGBT) for these families. All families retained in the study have or will participate(d) in assessments at the following time points: Intake (i.e., 4-5 months prior to the remote IGBT); Baseline (i.e., 1 month prior to the IGBT), Post-IGBT (i.e., 2 weeks following the IGBT), and School Year Follow Up (i.e., 16 weeks following the IGBT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Study Start: 2020-03-06
• Status Verified: 2020-12
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Child between the ages of 4-10 years, and his or her caregiver(s)
• Child meets DSM-5 criteria for selective mutism diagnosis
• Child speaks English fluently

Exclusion Criteria

• Child is identified as having any psychiatric condition significantly more impairing than selective mutism that requires alternate treatment
• The child is nonverbal with all caregivers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Global Impressions - Improvement (CGI-I) Scale rating at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The CGI-I Scale (Guy \& Bonato, 1970) is a widely used global improvement measure; improvement is rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Independent evaluators masked to family participation/progress during the intensive group behavioral treatment (IGBT) and the post-acute strategy will complete the CGI-I rating. "Treatment Response" is defined as an independent evaluator rated CGI-I rating of 1 or 2 (ratings \>/= 3 represent "Treatment Nonresponse").
Clinical Global Impressions - Improvement (CGI-I) Scale rating at Post-IGBT	Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)	The CGI-I Scale (Guy \& Bonato, 1970) is a widely used global improvement measure; improvement is rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Independent evaluators masked to family participation/progress during the intensive group behavioral treatment (IGBT) will complete the CGI-I rating. "Treatment Response" is defined as an independent evaluator rated CGI-I rating of 1 or 2 (ratings \>/= 3 represent "Treatment Nonresponse").

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The SMQ (Bergman et al., 2008) is a well-supported parent-report questionnaire with 23 items assessing child verbal behavior across settings (i.e., home, school, community) and associated impairment. Items are rated from 0 (never) to 3 (always).
Change from Baseline in School Speech Questionnaire (SSQ) scores at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The SSQ (Bergman et al., 2002) is a teacher-report adapted from the SMQ with 6 items assessing child verbal behavior in school. Items are rated from 0 (never) to 3 (always).
Change from Baseline in Children's Global Assessment Scale (CGAS) rating at Post-IGBT	Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)	The CGAS (Shaffer et al., 1983) is a widely used measure of overall child disturbance, with scores ranging from 0-100. Lower scores indicate greater functional impairment. Independent evaluators masked to family participation/progress during the caregiver training program and/or intensive group behavioral treatment (IGBT) will complete the CGAS rating.
Change from Baseline in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The CGAS (Shaffer et al., 1983) is a widely used measure of overall child disturbance, with scores ranging from 0-100. Lower scores indicate greater functional impairment. Independent evaluators masked to family participation/progress during the caregiver training program and/or intensive group behavioral treatment (IGBT) will complete the CGAS rating.
Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at Post-IGBT	Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)	The SMQ (Bergman et al., 2008) is a well-supported parent-report questionnaire with 23 items assessing child verbal behavior across settings (i.e., home, school, community) and associated impairment. Items are rated from 0 (never) to 3 (always).
Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at Post-IGBT	Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)	The ADIS (Silverman \& Albano, 1996) is a well-supported semi-structured diagnostic interview assessing child mental disorders in accordance with the Diagnostic and Statistical Manual (DSM). Disorders are assigned a clinical severity rating (CSR) along a 9-point scale ranging from 0-8 (CSRs \>/= 4 indicate diagnostic criteria were met). Independent evaluators masked to family participation/progress during the caregiver training program and/or intensive group behavioral treatment (IGBT) will administer the ADIS and determine CSRs.
Change from Baseline in Impairment Rating Scale - Parent Version (IRS-P) at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The IRS-P (Fabiano et al., 2006) is a 7-item parent-report measure of child impairment in the home, community, and school settings. Items are rated on a 7-point scale ranging from 0 (no problem) to 6 (extreme problem).
Change from Post-IGBT in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The ADIS (Silverman \& Albano, 1996) is a well-supported semi-structured diagnostic interview assessing child mental disorders in accordance with the Diagnostic and Statistical Manual (DSM). Disorders are assigned a clinical severity rating (CSR) along a 9-point scale ranging from 0-8 (CSRs \>/= 4 indicate diagnostic criteria were met). Independent evaluators masked to family participation/progress during the caregiver training program and/or intensive group behavioral treatment (IGBT) will administer the ADIS and determine CSRs.
Change from Post-IGBT in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The CGAS (Shaffer et al., 1983) is a widely used measure of overall child disturbance, with scores ranging from 0-100. Lower scores indicate greater functional impairment. Independent evaluators masked to family participation/progress during the caregiver training program and/or intensive group behavioral treatment (IGBT) will complete the CGAS rating.
Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The ADIS (Silverman \& Albano, 1996) is a well-supported semi-structured diagnostic interview assessing child mental disorders in accordance with the Diagnostic and Statistical Manual (DSM). Disorders are assigned a clinical severity rating (CSR) along a 9-point scale ranging from 0-8 (CSRs \>/= 4 indicate diagnostic criteria were met). Independent evaluators masked to family participation/progress during the caregiver training program and/or intensive group behavioral treatment (IGBT) and post-acute strategy will administer the ADIS and determine CSRs.
Change from Post-IGBT in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The SMQ (Bergman et al., 2008) is a well-supported parent-report questionnaire with 23 items assessing child verbal behavior across settings (i.e., home, school, community) and associated impairment. Items are rated from 0 (never) to 3 (always).
Change from Baseline in Impairment Rating Scale - Teacher Version (IRS-T) at School Year Follow Up	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)	The IRS-T (Fabiano et al., 2006) is an 8-item teacher-report measure of child impairment in the school setting. Items are rated on a 7-point scale ranging from 0 (no problem) to 6 (extreme problem).

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States