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

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ClinicalTrials.gov Identifier: NCT04451161
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : October 14, 2022
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Minnesota
Information provided by (Responsible Party):
Aaron Lyon, University of Washington

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
Evidence-Based Practices CBT School Health Services Trauma, Psychological Behavioral: Beliefs and Attitudes for Successful Implementation in Schools (BASIS) Behavioral: Trauma-Focused Cognitive-Behavioral Therapy Behavioral: Treatment as Usual Behavioral: Attention Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: 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).
Primary Purpose: Health Services Research
Official Title: A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.




Primary Outcome Measures :
  1. TF-CBT Adoption [ Time Frame: 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.

  2. Child PTSD Symptom Scale for DSM-V [ Time Frame: 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.

  3. Mood and Feelings Questionnaire - Short [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451161


Contacts
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Contact: Jessica Coifman 206-543-6483 jcoifman@uw.edu
Contact: Ian Muse imuse@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98115
Contact: Jessica Coifman, MA         
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
University of Minnesota
Investigators
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Principal Investigator: Aaron Lyon, PhD University of Washington
Principal Investigator: Clayton Cook, PhD University of Minnesota
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aaron Lyon, Associate Professor, School of Medicine: Psychiatry: Childrens Division, University of Washington
ClinicalTrials.gov Identifier: NCT04451161    
Other Study ID Numbers: STUDY00008401
1R01MH119148-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Psychological Trauma
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders