Clinical trial NCT04291638: 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
Overall status: COMPLETED
Phase: NA
Conditions: Selective Mutism
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 11
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Clinical Global Impressions - Improvement (CGI-I) Scale rating at Post-IGBT
timeFrame: Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Clinical Global Impressions - Improvement (CGI-I) Scale rating at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Secondary outcomes:
measure: Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at Post-IGBT
timeFrame: Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Baseline in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Post-IGBT in Anxiety Disorders Interview Schedule for Children (ADIS) Clinical Severity Ratings (CSRs) at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Baseline in Children's Global Assessment Scale (CGAS) rating at Post-IGBT
timeFrame: Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Baseline in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Post-IGBT in Children's Global Assessment Scale (CGAS) rating at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at Post-IGBT
timeFrame: Up to 3 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Baseline in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Post-IGBT in Selective Mutism Questionnaire (SMQ) scores at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Baseline in School Speech Questionnaire (SSQ) scores at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Baseline in Impairment Rating Scale - Parent Version (IRS-P) at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
measure: Change from Baseline in Impairment Rating Scale - Teacher Version (IRS-T) at School Year Follow Up
timeFrame: 16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Natalie Hong, M.S.
role: PRINCIPAL_INVESTIGATOR
References: