Improving Quality of Care in Child Mental Health Service Settings

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT03305458
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 16 Years
Healthy Volunteers
Accepted

Interventions

  • TFCBT — BEHAVIORAL
    treatment as usual
  • eTFCBT — BEHAVIORAL
    tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)

Study Details

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.

Key Dates

Start date
Oct 1, 2018
Status verified
May 2025
Primary completion
Feb 27, 2023
Completion
Oct 26, 2023

Study Design

Enrollment
713 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment as usual
    Trauma Focused Cognitive Behavioral Therapy
  • Experimental: Tablet-Facilitated TF-CBT
    Standard treatment with the addition of in-treatment/session iPad activities

Primary Outcome Measure

Child Involvement Ratings Scale (CIRS) [ Time Frame: 3 Month Timeline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in Charleston, SC

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Medical University of South Carolina· Charleston, SC

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