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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 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 713 participants.
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.
Interventions
- BEHAVIORAL TFCBT
- BEHAVIORAL eTFCBT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 713 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2023-10-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03305458
The ClinicalTrials.gov registry entry for NCT03305458 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 713 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TFCBT is the first listed.
NCT03305458 reports 0 study locations.
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.
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