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

University of Washington

Status

Completed

Conditions

CBT

Trauma, Psychological

Evidence-Based Practices

School Health Services

Treatments

Behavioral: Attention Control

Behavioral: Trauma-Focused Cognitive-Behavioral Therapy

Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS)

Behavioral: Treatment as Usual

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04451161

1R01MH119148-01A1 (U.S. NIH Grant/Contract)

STUDY00008401

Details and patient eligibility

About

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).

Enrollment

292 patients

Sex

All

Ages

7 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

292 participants in 3 patient groups

BASIS with TF-CBT

Other group

Description:

Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT)

Treatment:

Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS)

Behavioral: Trauma-Focused Cognitive-Behavioral Therapy

Attention Control (AC) with TF-CBT

Other group

Description:

Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)

Treatment:

Behavioral: Trauma-Focused Cognitive-Behavioral Therapy

Behavioral: Attention Control

Enhanced Treatment as Usual

Other group