N/A
N=727
Improving Quality of Care in Child Mental Health Service Settings
Post Traumatic Stress Disorder · Technology · Child Abuse
Bottom Line
View on ClinicalTrials.gov: NCT03305458 ↗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
| Outcome | Result | p-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
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.