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

NCT ID: NCT04291638

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2020-12-07

Brief Summary

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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).

Detailed Description

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Conditions

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Selective Mutism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
"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).

Study Groups

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Remote Caregiver Training

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

Group Type EXPERIMENTAL

Remote Caregiver Training

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Remote Caregiver Training

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Hong, M.S.

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

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Florida International University

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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20-0010

Identifier Type: -

Identifier Source: org_study_id