Clinical trial NCT04451161: A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Official title: A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Evidence-Based Practices
CBT
School Health Services
Trauma, Psychological
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Minnesota
First posted: 2020-06-30
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility 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.

Primary outcomes:
measure: TF-CBT Adoption
timeFrame: 18 Months
measure: Child PTSD Symptom Scale for DSM-V
timeFrame: 6 Months
measure: Mood and Feelings Questionnaire - Short
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Aaron Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Clayton Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.