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

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).

Study Overview

• Status: Recruiting
• Conditions: CBT; Trauma, Psychological; School Health Services; Evidence-Based Practices
• Intervention / Treatment: Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS); Behavioral: Trauma-Focused Cognitive-Behavioral Therapy; Behavioral: Attention Control; Behavioral: Treatment as Usual

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Coifman; Phone Number: 206-543-6483; Email: jcoifman@uw.edu
• Study Contact Backup: Name: Ian Muse; Email: imuse@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98115
      • Recruiting
      • University of Washington
      • Contact: Jessica Coifman, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 (grades 3 -12), (b) have traumatic event exposure (e.g., exposure to violence), and (c) significant post-traumatic stress symptoms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BASIS with TF-CBT; Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools) Clinical Intervention: experimental arm (Trauma-Focused CBT)	Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS); BASIS blended (i.e., multifaceted and protocolized) implementation strategy, which occurs at the beginning of active implementation. BASIS is designed to facilitate observable implementation outcomes, including EBP adoption and intervention fidelity, via strategic education, motivational Interviewing, and social influence strategies.; Behavioral: Trauma-Focused Cognitive-Behavioral Therapy; TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.
Other: AC with TF-CBT; Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT)	Behavioral: Trauma-Focused Cognitive-Behavioral Therapy; TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.; Behavioral: Attention Control; Didactic presentation of implementation-related content (e.g., information about the importance of implementing, definitions of key terms, etc.) to control for facilitator, dose, information provided, and delivery platform
Other: Enhanced Treatment as Usual; Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU)	Behavioral: Treatment as Usual; Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TF-CBT Adoption	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.	18 Months
Child PTSD Symptom Scale for DSM-V	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.	6 Months
Mood and Feelings Questionnaire - Short	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.	6 Months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); University of Minnesota
• Investigators: Principal Investigator: Aaron Lyon, PhD, University of Washington; Principal Investigator: Clayton Cook, PhD, University of Minnesota

Publications and helpful links

General Publications

• Lyon AR, Pullmann MD, Dorsey S, Levin C, Gaias LM, Brewer SK, Larson M, Corbin CM, Davis C, Muse I, Joshi M, Reyes R, Jungbluth NJ, Barrett R, Hong D, Gomez MD, Cook CR. Protocol for a hybrid type 2 cluster randomized trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy. Implement Sci. 2021 Jan 7;16(1):3. doi: 10.1186/s13012-020-01064-1.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Psychological Trauma
• Other Study ID Numbers: STUDY00008401; 1R01MH119148-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No