Selective MutismNCT04291638
Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism
A study testing Remote Caregiver Training and Remote Intensive Group Behavioral Treatment (IGBT) in people with Selective Mutism, run by Florida International University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Selective Mutism
- What is being tested?
- Remote Caregiver Training and Remote Intensive Group Behavioral Treatment (IGBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to 7 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
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).
- Conditions
- Selective Mutism
- Being tested
- Remote Caregiver Training, Remote Intensive Group Behavioral Treatment (IGBT)
- Medical subject headings
- Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Caregiver TrainingBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote Caregiver Training | Experimental | The Remote Caregiver Training arm consists of participation in a 5-hour, videoconferencing-based caregiver training program. Receives: Behavioral: Remote Caregiver Training |
| Remote Caregiver Training + Intensive Treatment | Experimental | 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. Receives: Behavioral: Remote Caregiver Training; Behavioral: Remote Intensive Group Behavioral Treatment (IGBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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").
Measured: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start6 Mar 2020
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective MutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Hong, M.S., Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291638
- Sponsor's protocol ID
- 20-0010
- Status last verified
- Dec 2020
- First submitted
- 21 Feb 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism
- ClinicalTrials.gov ID
- NCT04291638
- Acronym / sponsor ID
- 20-0010
- Conditions
- Selective Mutism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Remote Caregiver Training | Experimental | Behavioral: Remote Caregiver TrainingThe Remote Caregiver Training arm consists of participation in a 5-hour, videoconferencing-based caregiver training program. |
| Remote Caregiver Training + Intensive Treatment | Experimental | Behavioral: Remote Caregiver Training, Behavioral: Remote Intensive Group Behavioral Treatment (IGBT)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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Caregiver TrainingThe 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. | Behavioural | Remote Caregiver Training, Remote Caregiver Training + Intensive Treatment |
| 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. | Behavioural | Remote Caregiver Training + Intensive Treatment |
Primary outcome
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").
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").
12 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Selective Mutism
Recruiting
VR Homework Exercises for Selective Mutism Treatment
Selective Mutism, Anxiety Disorder of Childhood
Recruiting
Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Hong, M.S. principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Caregiver Training and Remote Intensive Group Behavioral Treatment (IGBT) in people with Selective Mutism, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.