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NCT03305458 · ClinicalTrials.gov registry record · NA

Improving Quality of Care in Child Mental Health Service Settings

A NA study, sponsored by Medical University of South Carolina.

Completed
Registry status
NA
Development phase
713
Enrollment target

NCT03305458: Completed NA study, sponsored by Medical University of South Carolina.

NCT03305458 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 713 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03305458, a NA study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
NA
Development phase
713 participants
Enrollment target

Study Summary

The investigators recently completed an NIMH R34 in which they piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children's engagement and supports adherence to the treatment model. The tablet-based toolkit was very well received by children, caregivers, and providers in the pilot evaluation. Moreover, all benchmarks for feasibility were met or exceeded. This study proposes to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children's mental health outcomes. The investigators will conduct a randomized controlled trial with 120 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators. Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses. The investigators will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives. Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact.

Primary Outcome

Child engagement will be measured via coding of audiotaped sessions by independent, trained raters who are blind to study purpose and hypotheses. The Child Involvement Ratings Scale (CIRS) will be used to code child engagement. Ten "child involvement" items-6 positive, 4 negative- are rated for each session on a 6-point scale. The minimum total score will be 0 and the maximum score is 50. For the outcome, a single average value will be presented. The positive-involvement items emphasize the exte

Interventions

  • BEHAVIORAL TFCBT
  • BEHAVIORAL eTFCBT

Trial Details

FieldValue
Enrollment Target 713 participants
Start Date 2018-10-01
Est. Completion 2023-10-26
Phase NA

What the finished NCT03305458 record still lists

NCT03305458 is an interventional study that assigns participants to a tested intervention. The registered 713 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% lower).

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

NCT03305458 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03305458 about?

NCT03305458 is a clinical study titled "Improving Quality of Care in Child Mental Health Service Settings". The investigators recently completed an NIMH R34 in which they piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a wide range of symptoms using tec...

What is the current status of trial NCT03305458?

This trial is currently completed. It is a NA study. The enrollment target is 713 participants. The study started on 2018-10-01. Estimated completion is 2023-10-26.

What interventions are being tested in trial NCT03305458?

The interventions under investigation include: TFCBT (BEHAVIORAL), eTFCBT (BEHAVIORAL).

Who is sponsoring clinical trial NCT03305458?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03305458's enrollment target sits among peer trials

713 147th of 2000 higher than 1,854 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 NCT03305458, the US trial registry maintained by the National Library of Medicine. NCT03305458 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.