A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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.
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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 (grades 3 -12), (b) have traumatic event exposure (e.g., exposure to violence), and (c) significant post-traumatic stress symptoms.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Washington | Seattle | Washington | United States | 98115 |
Sponsors and Collaborators
- University of Washington
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00008401
- 1R01MH119148-01A1