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

NCT04291638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-12-16

No results posted yet for this study

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).

Conditions

  • Selective Mutism

Interventions

BEHAVIORAL

Remote Caregiver Training

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Florida International University

    lead OTHER

Principal Investigators

  • Natalie Hong, M.S. · Florida International University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2020-12-07
Completion
2020-12-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291638 on ClinicalTrials.gov