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N/A N=727 Randomized Single-blind Treatment

Improving Quality of Care in Child Mental Health Service Settings

Post Traumatic Stress Disorder · Technology · Child Abuse

Enrolled (actual)
727
Serious AEs
0.8%
Results posted
Jun 2025
Primary outcome: Primary: Child Involvement Ratings Scale (CIRS) — 1.95; 2.01 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
TFCBT (Behavioral); eTFCBT (Behavioral)
Age
Pediatric · 8+ yrs
Sex
All
Sponsor
Medical University of South Carolina
Primary completion
Feb 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Child Involvement Ratings Scale (CIRS)
1.95; 2.01
PRIMARY
Provider Treatment Fidelity (TPOCS)
.50; .43
SECONDARY
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
25.21; 23.61; 20.88; 20.66; 19.22; 18.91
SECONDARY
Therapeutic Alliance Scale for Children (TASC)
21.27; 20.67
SECONDARY
Child/Adolescent Satisfaction Questionnaire (CASQ).
51.20; 50.91
SECONDARY
The Shame Measure
2.40; 2.08; 1.58; 1.54; 1.34; 1.34
SECONDARY
The Child and Adolescent Trauma Screen (CATS) - Youth Version
21.50; 21.66; 16.33; 16.83; 13.74; 14.51
SECONDARY
Caregiver Satisfaction Questionnaire (CSQ)
52.46; 52.79
SECONDARY
Working Alliance Inventory (WAI-short Form)
51.4; 51.03
SECONDARY
Brief Problems Monitor (BPM)
14.5; 14.9; 12.1; 13.3; 10.6; 12.7
SECONDARY
Center for Epidemiologic Studies Depression Scale (CESD-R).
17.94; 18.28; 14.77; 16.23; 12.94; 23.88
SECONDARY
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
21.16; 20.27; 13.80; 16.70; 13.95; 13.85
SECONDARY
The Alabama Parenting Questionnaire
43.72; 44.37; 43.26; 45.18; 43.44; 44.39
SECONDARY
The Kessler 6
6.10; 6.33; 4.86; 5.48; 4.96; 5.42
SECONDARY
Evidence-Based Practice Attitude Scale (EBPAS)
38.35; 38.83; 36.16; 39.39; 36.91; 35.19
SECONDARY
Knowledge of Behavioral Principles as Applied to Children
48; 53; 123; 27; 35; 53
SECONDARY
Acceptability, Appropriateness and Feasibility Measure (AIMIAMFIM)
53.94; 55.66; 52.10; 44.26; 52.86; 47.19
SECONDARY
Computer Assisted Therapy Attitudes Scale
21.90; 19.79; 21.13; 20.96; 18.97; 20.67
SECONDARY
Organizational Readiness for Implementing Change
53.29; 51.87; 20.37; 46.57; 48.65; 47.13
SECONDARY
TF-CBT Organizational Support Measure
62.96; 61.75; 62.48; 63.63; 63.43; 61.02
SECONDARY
Burnout Measure
10.11; 10.12; 10.17

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.

Eligibility Criteria

Inclusion Criteria

  • victim of at least one potentially traumatic event (e.g. sexual/physical assault, witnessed violence, disaster, serious accident)
  • have at least one symptom on each PTSD symptom cluster (re-experiencing, avoidance, hyperarousal)

Exclusion Criteria

  • exhibits psychotic symptoms (active hallucinations, delusions, impaired thought processes) by caregiver or child
  • significant cognitive disabilities, developmental delays, or pervasive developmental disorder
  • active suicidal or homicidal ideations
  • no consistent caregiver available to participate
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03305458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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