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NCT04291638 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Florida International University.

Completed
Registry status
NA
Development phase
11
Enrollment target

NCT04291638: Completed NA study, sponsored by Florida International University.

NCT04291638 is a NA study that has completed, run by Florida International University. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04291638, a NA study, has completed, sponsored by Florida International University.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target

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).

Primary Outcome

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").

Interventions

  • BEHAVIORAL Remote Caregiver Training
  • BEHAVIORAL Remote Intensive Group Behavioral Treatment (IGBT)

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2020-03-06
Est. Completion 2020-12-07
Phase NA
Florida International University

89 total trials

What the finished NCT04291638 record still lists

NCT04291638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Remote Caregiver Training is the first listed.

NCT04291638 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04291638 about?

NCT04291638 is a clinical study titled "Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism". 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...

What is the current status of trial NCT04291638?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2020-03-06. Estimated completion is 2020-12-07.

What interventions are being tested in trial NCT04291638?

The interventions under investigation include: Remote Caregiver Training (BEHAVIORAL), Remote Intensive Group Behavioral Treatment (IGBT) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04291638?

This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04291638's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04291638, the US trial registry maintained by the National Library of Medicine. NCT04291638 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.