CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 713 enrolled
Drug / intervention
TFCBT +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03305458
NCT03305458N/ACompleted

Improving Quality of Care in Child Mental Health Service Settings

Medical University of South Carolina·interventional·Posted Oct 10, 2017·Updated Jun 6, 2025

In Brief

A clinical study evaluating TFCBT and eTFCBT for Post Traumatic Stress Disorder and 2 related conditions. Completed, enrolled 713 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 10, 2017
Enrollment StartOct 1, 2018
Primary CompletionFeb 27, 2023
Study CompletionOct 26, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.7 years ago

Interventions

TFCBTbehavioral

treatment as usual

eTFCBTbehavioral

tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)