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Randomized Controlled Trial
. 2019 Feb;204:271-281.
doi: 10.1016/j.schres.2018.08.015. Epub 2018 Aug 20.

Implementation and Fidelity Assessment of the NAVIGATE Treatment Program for First Episode Psychosis in a Multi-Site Study

Free PMC article
Randomized Controlled Trial

Implementation and Fidelity Assessment of the NAVIGATE Treatment Program for First Episode Psychosis in a Multi-Site Study

Kim T Mueser et al. Schizophr Res. .
Free PMC article


The NAVIGATE program was developed for the Recovery After Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, which compared NAVIGATE to usual Community Care in a cluster randomized design involving 34 sites and 404 patients. This article describes the approach to training and implementing the NAVIGATE program at the 17 sites (including 134 practitioners) randomized to provide it, and to evaluating the fidelity of service delivery to the NAVIGATE model. Fidelity was evaluated to five different components of the program, all of which were standardized in manuals in advance of implementation. The components included four interventions (Individualized Resiliency Training, Family Education Program, Supported Employment and Education, Personalized Medication Management) and the overall organization (staffing and structure) of the NAVIGATE team. Most of the sites demonstrated acceptable or higher levels of fidelity in their implementation of the four interventions and the organization of the program, with all 17 sites demonstrating at least acceptable overall fidelity to the NAVIGATE program. The results indicate that the NAVIGATE program can be implemented with good fidelity to the treatment model in a diverse array of community mental health care settings serving persons with a first episode psychosis.

Trial registration: NCT01321177.

Keywords: Coordinated specialty care; Fidelity; Implementation; Training.

Conflict of interest statement


The authors and their associates provide training and consultation regarding implementation of NAVIGATE treatment that can include compensation. These activities started only after data collection for the article was completed. At the time of publication, Dr. Robinson, Dr. Meyer-Kalos, Dr. Mueser, Ms. Gingerich, Mr. Lynde, Dr. Glynn and Dr. Cather have received compensation for these activities.

Dr. Kane has been a consultant to or received honoraria from Alkermes, Bristol Myers Squibb, Eli Lilly, Forrest Labs, Genentech, Intracellular Therapeutics, Janssen, Johnson and Johnson, Lundbeck, Merck, Neurocrine, Novartis, Otsuka, Proteus, Reviva, Roche, Sumitomo Dainippon, Sunovion and Teva. He is a shareholder in MedAvante, LB Pharmaceuticals and The Vanguard Research group. Constance R. Klein, RN, MPA owns shares in Bristol-Myers Squibb, GlaxoSmithKline, and Merck.

Dr. Meyer-Kalos has consulted for Sumitomo Dainippon Pharma Co., Ltd.

Dr. Robinson has been a consultant to 3D Communications, Asubio, Costello Medical, Innovative Science Solutions, Janssen and Otsuka.

Dr. Schooler has served on advisory boards or as a consultant for Alkermes, Allergan, Eli Lilly, Forum (formerly EnVivo), Roche, and Sunovion, and she has received grant/research support from Otsuka.

All other authors declare that they have no conflicts of interest (Addington, Estroff, Gottlieb, Penn, Potretzke, Rosenheck, and Wiseman).

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