# Laboratory for Early Psychosis Research (LEAP)

> **NIH NIH P50** · MCLEAN HOSPITAL · 2024 · $2,037,513

## Abstract

1. Abstract
We propose to continue our existing NIMH P50 ALACRITY Center (Laboratory for Early Psychosis or LEAP
Center). Although coordinated specialty care (CSC) is standard of care for patients with first episode psychosis
(FEP), there remain gaps in our knowledge base regarding selection and deployment of treatments. The LEAP
Center has been addressing these gaps through development of a statewide CSC clinic system in
Massachusetts, standardized data collection and participation in the EPINET consortium, and adapting
methods developed outside of mental health. In the first LEAP Center period, we have generated strong
interdisciplinary collaborations between clinicians, policy makers/regulators, and stakeholders, and FEP
experts from across the country plus scientific experts from outside of mental health, e.g., in data science,
machine learning, epidemiology, and health policy. In the next period, we will leverage these collaborations to
conduct a randomized clinical trial and to access diverse data sources to examine the role of specific treatment
interventions in FEP. We also will apply and develop modern methods for clinical prediction and comparative
effectiveness research (CER) for FEP research. We have three overall Center aims: 1) Collaborations; 2)
Clinical research; and 3) Prediction and CER methods. The Center will include four complementary projects: 1)
Project 1 is a “signature” project to conduct a cluster randomized clinical trial of enhanced CSC. 2) Project 2
will apply causal inference techniques on FEP-CAUSAL, an international data platform; 3) Project 3 will
leverage EPINET national registry data to estimate the effect of treatment exposures studied in Project 1; 4)
Project 4 will compare CSC care with non-CSC care at the state level using both electronic health record and
statewide administrative datasets. The Administrative Core and Methods Core bind these projects and the
multiple types of data (i.e., experimental data and observational data from electronic health records, national
registries, or administrative datasets) and analytic approaches together. We have a group of Scientific
Advisors, Center Faculty from diverse scientific disciplines (e.g., those that historically have had limited mental
health research exposure), and Stakeholders (e.g., policy makers, organizational leaders, and patient and
family advocates) who will be deeply involved in the Center from design to dissemination. The overall goal is to
continue the evolution towards a state-wide learning health system for early psychosis which started in the first
LEAP Center period and to continue to support NIMH-sponsored EPINET learning health system consortium.

## Key facts

- **NIH application ID:** 10918293
- **Project number:** 5P50MH115846-06
- **Recipient organization:** MCLEAN HOSPITAL
- **Principal Investigator:** MIGUEL HERNAN
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $2,037,513
- **Award type:** 5
- **Project period:** 2019-05-15 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918293

## Citation

> US National Institutes of Health, RePORTER application 10918293, Laboratory for Early Psychosis Research (LEAP) (5P50MH115846-06). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10918293. Licensed CC0.

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