N/A
Completed N=292
A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Evidence-Based Practices · CBT · School Health Services · Trauma, Psychological
Source: ClinicalTrials.gov NCT04451161 ↗
Enrolled (actual)
292
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: TF-CBT Adoption and Penetration — 33; 26; 33; 31 Participants — p=0.591
Summary
This research project is a hybrid type 2 effectiveness-implementation trial that simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in the education sector and (2) the impact of a theory-driven pragmatic implementation strategy designed to increase the adoption, fidelity, and sustainment of evidence-based treatments (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in a new setting that increases access to mental health care - schools (Aim 1); test the cost effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data collection to explain residuals (i.e., clinicians whose implementation behavior is unaccounted for by the mediation model) (Aim 2c).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TF-CBT Adoption and Penetration |
33; 26; 33; 31; 26; 21 | 0.591 |
| PRIMARY Child PTSD Symptom Scale for DSM-V |
34.7; 39.3; 37.1; 28.3; 34.4; 28.1 | 0.22 |
| PRIMARY Mood and Feelings Questionnaire - Short |
10.3; 11.7; 10.7; 7.7; 12.1; 7.2 | 0.284 |
Eligibility Criteria
Clinicians will be included if they (a) provide school-based services in a participating district; (b) have not previously received formal training in TF-CBT; and (c) are not actively receiving support to implement another trauma-focused intervention.
Students subjects will meet TF-CBT eligibility criteria, including (a) be within the TF-CBT developmental range (ages 8 to 19), (b) have traumatic event exposure (e.g., exposure to violence), and (c) significant post-traumatic stress symptoms.
Data sourced from ClinicalTrials.gov (NCT04451161). 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. Informational only — not medical advice.