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

Study Overview
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Brief Summary
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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).

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

Conditions
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Selective Mutism

Intervention / Treatment
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* Behavioral: Remote Caregiver Training
* Behavioral: Remote Intensive Group Behavioral Treatment (IGBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participating families attend videoconferencing-based group parent training sessions. Families are given the opportunity to opt in to participate in the videoconferencing-based intensive group behavioral treatment program (remote IGBT).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Caregiver Training<br>The Remote Caregiver Training arm consists of participation in a 5-hour, videoconferencing-based caregiver training program. | Behavioral: Remote Caregiver Training<br>* 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.<br>|
| Experimental: Remote Caregiver Training + Intensive Treatment<br>The Remote Caregiver Training + Intensive Treatment arm consists of participation in a 5-hour, videoconferencing-based caregiving training program, followed by participation in the videoconferencing-based intensive group behavioral treatment program. | Behavioral: Remote Caregiver Training<br>* 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.<br>Behavioral: Remote Intensive Group Behavioral Treatment (IGBT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |