Protocol for a hybrid type 2 cluster randomized trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy

Aaron R. Lyon, Michael D. Pullmann, Shannon Dorsey, Carol Levin, Larissa M. Gaias, Stephanie K. Brewer, Madeline Larson, Catherine M. Corbin, Chayna Davis, Ian Muse, Mahima Joshi, Rosemary Reyes, Nathaniel J. Jungbluth, Rachel Barrett, David Hong, Michael D. Gomez, Clayton R. Cook

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background: More than two-thirds of youth experience trauma during childhood, and up to 1 in 5 of these youth develops posttraumatic stress symptoms that significantly impair their functioning. Although trauma-focused cognitive behavior therapy (TF-CBT) has a strong evidence base, it is rarely adopted, delivered with adequate fidelity, or evaluated in the most common setting where youth access mental health services—schools. Given that individual behavior change is ultimately required for successful implementation, even when organizational factors are firmly in place, focusing on individual-level processes represents a potentially parsimonious approach. Beliefs and Attitudes for Successful Implementation in Schools (BASIS) is a pragmatic, motivationally focused multifaceted strategy that augments training and consultation and is designed to target precise mechanisms of behavior change to produce enhanced implementation and youth clinical outcomes. This study protocol describes a hybrid type 2 effectiveness-implementation trial designed to concurrently evaluate the main effects, mediators, and moderators of both the BASIS implementation strategy on implementation outcomes and TF-CBT on youth mental health outcomes. Methods: Using a cluster randomized controlled design, this trial will assign school-based mental health (SMH) clinicians and schools to one of three study arms: (a) enhanced treatment-as-usual (TAU), (b) attention control plus TF-CBT, or (c) BASIS+TF-CBT. With a proposed sample of 120 SMH clinicians who will each recruit 4–6 youth with a history of trauma (480 children), this project will gather data across 12 different time points to address two project aims. Aim 1 will evaluate, relative to an enhanced TAU condition, the effects of TF-CBT on identified mechanisms of change, youth mental health outcomes, and intervention costs and cost-effectiveness. Aim 2 will compare the effects of BASIS against an attention control plus TF-CBT condition on theoretical mechanisms of clinician behavior change and implementation outcomes, as well as examine costs and cost-effectiveness. Discussion: This study will generate critical knowledge about the effectiveness and cost-effectiveness of BASIS—a pragmatic, theory-driven, and generalizable implementation strategy designed to enhance motivation—to increase the yield of evidence-based practice training and consultation, as well as the effectiveness of TF-CBT in a novel service setting. Trial registration: ClinicalTrials.gov registration number NCT04451161. Registered on June 30, 2020.

Original languageEnglish (US)
Article number3
JournalImplementation Science
Volume16
Issue number1
DOIs
StatePublished - Jan 7 2021

Bibliographical note

Funding Information:
This publication was supported by grant R01MH119148 (Lyon and Cook), awarded by the National Institute of Mental Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Publisher Copyright:
© 2021, The Author(s).

Keywords

  • Education sector
  • Health action process approach
  • Implementation strategy
  • Individual determinants
  • Mental health
  • Theory of planned behavior

PubMed: MeSH publication types

  • Journal Article
  • Research Support, N.I.H., Extramural

Fingerprint

Dive into the research topics of 'Protocol for a hybrid type 2 cluster randomized trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy'. Together they form a unique fingerprint.

Cite this