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

Primary Purpose

Selective Mutism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Caregiver Training
Remote Intensive Group Behavioral Treatment (IGBT)
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Selective Mutism

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Remote Caregiver Training

Remote Caregiver Training + Intensive Treatment

Arm Description

The Remote Caregiver Training arm consists of participation in a 5-hour, videoconferencing-based caregiver training program.

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.

Outcomes

Primary Outcome Measures

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").
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").

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).

Full Information

First Posted
February 21, 2020
Last Updated
December 14, 2020
Sponsor
Florida International University
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1. Study Identification

Unique Protocol Identification Number
NCT04291638
Brief Title
Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism
Official Title
Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selective Mutism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
"Independent evaluators" assigned to assess outcomes at Post-IGBT and School Year Follow-Up time points will be unfamiliar with families' progress during the IGBT, as well as masked to treatment participation (i.e., whether or not families participated in the remote IGBT).
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Caregiver Training
Arm Type
Experimental
Arm Description
The Remote Caregiver Training arm consists of participation in a 5-hour, videoconferencing-based caregiver training program.
Arm Title
Remote Caregiver Training + Intensive Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Remote Caregiver Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Remote Intensive Group Behavioral Treatment (IGBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Global Impressions - Improvement (CGI-I) Scale rating at Post-IGBT
Description
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").
Time Frame
Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Clinical Global Impressions - Improvement (CGI-I) Scale rating at School Year Follow Up
Description
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").
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary Outcome Measure Information:
Title
Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at Post-IGBT
Description
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.
Time Frame
Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up
Description
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.
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Post-IGBT in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up
Description
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.
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Baseline in Children's Global Assessment Scale (CGAS) rating at Post-IGBT
Description
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.
Time Frame
Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Baseline in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up
Description
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.
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Post-IGBT in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up
Description
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.
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at Post-IGBT
Description
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).
Time Frame
Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up
Description
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).
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Post-IGBT in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up
Description
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).
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Baseline in School Speech Questionnaire (SSQ) scores at School Year Follow Up
Description
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).
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Baseline in Impairment Rating Scale - Parent Version (IRS-P) at School Year Follow Up
Description
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).
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Title
Change from Baseline in Impairment Rating Scale - Teacher Version (IRS-T) at School Year Follow Up
Description
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).
Time Frame
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Hong, M.S.
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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