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

Selective Mutism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291638
• Other study ID #: 20-0010
• Status: Completed
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: December 2020
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Mutism
• Selective Mutism

Intervention

Behavioral:
• Remote Caregiver Training
The remote caregiver training is a 5-hour videoconferencing-based training program that focuses on teaching cognitive behavioral therapy skills to the caregivers of children with selective mutism in a group format across 3 sessions.
• Remote Intensive Group Behavioral Treatment (IGBT)
The remote IGBT is a 5-day videoconferencing-based treatment program that delivers cognitive behavioral therapy to children and their caregivers in a group format across 2-3 hours per day.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impressions - Improvement (CGI-I) Scale rating at Post-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").	Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
Primary	Clinical Global Impressions - Improvement (CGI-I) Scale rating at School Year Follow Up	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").	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at Post-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.	Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up	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.	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Post-IGBT in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up	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.	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in Children's Global Assessment Scale (CGAS) rating at Post-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.	Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up	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.	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Post-IGBT in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up	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.	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at Post-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).	Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up	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).	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Post-IGBT in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up	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).	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in School Speech Questionnaire (SSQ) scores at School Year Follow Up	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).	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in Impairment Rating Scale - Parent Version (IRS-P) at School Year Follow Up	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).	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary	Change from Baseline in Impairment Rating Scale - Teacher Version (IRS-T) at School Year Follow Up	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).	16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)