- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04291638
Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism
December 14, 2020 updated by: Florida International University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33199
- Florida International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remote Caregiver Training
The Remote Caregiver Training arm consists of participation in a 5-hour, videoconferencing-based caregiver training program.
|
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.
|
Experimental: Remote Caregiver Training + Intensive Treatment
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impressions - Improvement (CGI-I) Scale rating at Post-IGBT
Time Frame: 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").
|
Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
|
Clinical Global Impressions - Improvement (CGI-I) Scale rating at School Year Follow Up
Time Frame: 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").
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
|
Change from Baseline in Children's Global Assessment Scale (CGAS) rating at Post-IGBT
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
|
Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at Post-IGBT
Time Frame: 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).
|
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
Time Frame: 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).
|
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
Time Frame: 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).
|
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
|
Change from Baseline in School Speech Questionnaire (SSQ) scores at School Year Follow Up
Time Frame: 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).
|
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
Time Frame: 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).
|
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
Time Frame: 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).
|
16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Natalie Hong, M.S., Florida International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2020
Primary Completion (Actual)
December 7, 2020
Study Completion (Actual)
December 7, 2020
Study Registration Dates
First Submitted
February 21, 2020
First Submitted That Met QC Criteria
February 27, 2020
First Posted (Actual)
March 2, 2020
Study Record Updates
Last Update Posted (Actual)
December 16, 2020
Last Update Submitted That Met QC Criteria
December 14, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-0010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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