A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
September 2, 2025 updated by: Aaron Lyon, University of Washington
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
Completed
Study Type
Interventional
Enrollment (Actual)
292
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
-
Seattle, Washington, United States, 98115
- University of Washington
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 (ages 8 to 19), (b) have traumatic event exposure (e.g., exposure to violence), and (c) significant post-traumatic stress symptoms.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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) |
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.
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: Enhanced Treatment as Usual
Implementation intervention: non-applicable Clinical Intervention: control arm (Enhanced TAU) |
Scaffolded intervention as usual.
Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.
|
|
Other: Attention Control (AC) with TF-CBT
Implementation intervention: control arm Clinical Intervention: experimental arm (Trauma-Focused CBT) |
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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TF-CBT Adoption and Penetration
Time Frame: 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. |
18 Months- Active phase (timepoint 6 to 9); Sustainment phase (timepoint 10 to 12)
|
|
Child PTSD Symptom Scale for DSM-V
Time Frame: 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.
|
6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)
|
|
Mood and Feelings Questionnaire - Short
Time Frame: 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).
|
6 Months - Baseline (T1); 3-month follow up (T2); 6-month follow up (T3)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aaron Lyon, PhD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2020
Primary Completion (Actual)
June 1, 2024
Study Completion (Actual)
June 30, 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 (Estimated)
September 12, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
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