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

NCT04451161 | Completed Results DMC

• 2 other identifiers: STUDY000084011R01MH119148-01A1
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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).

Conditions

Evidence-Based Practices; CBT; School Health Services; Trauma, Psychological

Outcome Measures

Primary Outcomes (3)

• TF-CBT Adoption and Penetration

  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.

  18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)

• Child PTSD Symptom Scale for DSM-V

  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.

  6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)

• Mood and Feelings Questionnaire - Short

  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).

  6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)

Study Arms (3)

BASIS with TF-CBT

OTHER

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); Behavioral: Trauma-Focused Cognitive-Behavioral Therapy

Attention Control (AC) with TF-CBT

OTHER

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

Behavioral: Trauma-Focused Cognitive-Behavioral Therapy; Behavioral: Attention Control

Enhanced Treatment as Usual

OTHER

Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU)

Behavioral: Treatment as Usual

Interventions

Beliefs and Attitudes for Successful Implementation in Schools (BASIS) BEHAVIORAL

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.

BASIS with TF-CBT

Trauma-Focused Cognitive-Behavioral Therapy BEHAVIORAL

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.

Attention Control (AC) with TF-CBT; BASIS with TF-CBT

Treatment as Usual BEHAVIORAL

Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.

Enhanced Treatment as Usual

Attention Control BEHAVIORAL

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

Attention Control (AC) with TF-CBT

Eligibility Criteria

• Age: 7 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Minnesota: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

Location

Related Publications (1)

• 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.

  PMID: 33413511 DERIVED

MeSH Terms

Conditions

Psychological Trauma

Interventions

Schools; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Results Point of Contact

• Title: Dr. Aaron Lyon
• Organization: University of Washington

lyona@uw.edu

(206) 221-8604

Study Officials

• Aaron Lyon, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care provider is not masked to the intervention condition they are in (ie, TF-CBT vs TAU), but will be masked to the implementation strategy (ie, Attention Control vs. BASIS).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Psychiatry: Childrens Division

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 30, 2020
• Study Start: August 27, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: September 12, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-09

Locations

US (1)