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

Trauma, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451161
• Other study ID #: STUDY00008401
• Secondary ID: 1R01MH119148-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2020
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: Jessica Coifman
• Phone: 206-543-6483
• Email: jcoifman[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• CBT
• Evidence-Based Practices
• Psychological Trauma
• School Health Services
• Trauma, Psychological
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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