A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy

Not Applicable

Active, not recruiting

Conditions: Evidence-Based Practices
School Health Services
Trauma, Psychological
CBT

Registration Number: NCT04451161

Lead Sponsor: University of Washington

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 292

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TF-CBT Adoption and Penetration	18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)	Participants provided data every 2-3 months for up to two years, reporting: How many students received CPSS-V (PTSD screener)? With how many students was TF-CBT initiated? With how many students was it completed? This allowed for monitoring of both reach (screening) and implementation (initiation/completion) of TF-CBT.
Child PTSD Symptom Scale for DSM-V	6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)	The Child PTSD Symptom Scale Self-Report for DSM-5 (CPSS-V) is a modified version of the original CPSS-SR adapted for DSM-5 criteria. The scale includes 20 PTSD symptom items scored on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("6 or more times a week / severe"), where higher scores indicate greater symptom severity. The scale includes 7 functioning items rated as "yes" or "no." The total score ranges from 0 to 80, with higher scores reflecting worse PTSD symptom severity.
Mood and Feelings Questionnaire - Short	6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)	The Short Mood and Feelings Questionnaire (SMFQ) is a 13-item self-report measure assessing recent emotional and behavioral states. It consists of descriptive phrases rated based on how often they applied to the subject over the past two weeks: 0 ("not at all"), 1 ("sometimes"), or 2 ("most of the time"). The total score ranges from 0 to 26, with higher scores indicating greater severity of depressive symptoms (worse outcome).