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
• Interventions: Behavioral: Treatment as Usual; Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS); Behavioral: Trauma-Focused Cognitive-Behavioral Therapy; Behavioral: Attention Control

• 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

Study Timeline

• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-30
• Study Start: 2020-08-27
• Primary Completion: 2024-06-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Treatment as Usual	Treatment as Usual	Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU)
BASIS with TF-CBT	Beliefs and Attitudes for Successful Implementation in Schools (BASIS)	Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT)
BASIS with TF-CBT	Trauma-Focused Cognitive-Behavioral Therapy	Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT)
AC with TF-CBT	Attention Control	Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)
AC with TF-CBT	Trauma-Focused Cognitive-Behavioral Therapy	Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)

Primary Outcome Measures

Name	Time	Method
TF-CBT Adoption	18 Months	Adoption is operationalized as the initiation of a clinican's first TF-CBT session at any point during study participation. These data will be collected from an online TF-CBT "Toolkit" that facilitates tracking of services delivered and has been commonly used for large-scale TF-CBT implementation.
Child PTSD Symptom Scale for DSM-V	6 Months	The CPSS-SR-5 is a modified version of Child PTSD Symptom Scale self-report (CPSS-SR) for DSM-5. The 20 PTSD symptom items are rated on a 5-point scale of frequency and severity from 0 (not at all) to 4 (6 or more times a week /severe). The 7 functioning items are rated on yes/no.
Mood and Feelings Questionnaire - Short	6 Months	The SMFQ consists of a series of descriptive phrases regarding how the subject has been feeling or acting recently. Codings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all in the past two weeks.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States