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

NCT04291638 | Completed

• 1 other identifier: 20-0010
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Selective Mutism

Outcome Measures

Primary Outcomes (2)

• 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").

  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").

  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

  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

  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

  16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)

• Change from Baseline in Children's Global Assessment Scale (CGAS) rating at Post-IGBT

  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

  16-18 weeks after the Intensive Group Behavioral Treatment (IGBT)

Study Arms (2)

Remote Caregiver Training

EXPERIMENTAL

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

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.

Behavioral: Remote Caregiver Training; Behavioral: Remote Intensive Group Behavioral Treatment (IGBT)

Interventions

Remote Caregiver Training 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; Remote Caregiver Training + Intensive Treatment

Remote Intensive Group Behavioral Treatment (IGBT) 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.

Remote Caregiver Training + Intensive Treatment

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Mutism

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Natalie Hong, M.S.

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: "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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 2, 2020
• Study Start: March 6, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

US (1)