# Toward a Generalized Framework and Flexible Software Environment for Power Analysis of Alcohol Treatment Randomized Controlled Trials

> **NIH NIH R01** · PURDUE UNIVERSITY · 2020 · $671,748

## Abstract

PROJECT SUMMARY
Pharmacological and behavioral treatments of alcohol use disorder are only useful to the extent that their
effects are robust and reliable. A priori determination of statistical power is one of the most significant steps
to maximizing scientific reliability; however, it has historically been largely overlooked in the health sciences.
Alcohol researchers are increasingly utilizing complex statistical models (e.g., growth curves, mixture models,
social networks); yet, accessible methods for sample size determination for all but the simplest statistical tests
have not been broadly disseminated. Moreover, even for models in which software programs are readily
available, scientists consistently express uncertainty regarding expected parameter estimates, prohibiting the
utility of power analysis itself. As a result, many randomized controlled trials (RCTs) are likely not optimally
designed to allow for conclusive statistical inference. The overall objective of this proposal is to close this gap
by developing a generalized method for power analysis using a combination of established and innovative
approaches that can be used to generate and test a vast array of models used in treatment research. This
objective will be achieved by pursuing two specific aims: develop a flexible, user-friendly software interface for
statistical power and sensitivity analysis (Aim 1); and develop a generalized framework for determining model
parameter estimates (Aim 2). The proposal is innovative because the software interface will be grounded in
state-of-the-art advancements in computational technology and human-computer interaction. In addition, the
framework will be fortified by advances in generalizability-theory-based meta-analyses and guided walk and
machine-learning-based simulation studies investigating the effects of uncertainty in individual model
parameters on the likelihood of observing hypothesized effects. The software will include automated sensitivity
analyses to identify parameters with the largest impact on power and will recommend starting parameters.
Development and testing will be grounded in the naltrexone and cognitive behavioral therapy literatures. Their
widespread use and diversity of methodological approaches make them ideal testbeds from which to
generalize to other treatment domains. This research is synergistic with each of the goals within the NIAAA
Strategic Plan (2017-2021). Perhaps most significantly, methodology and guidelines will be developed for
designing RCTs that have sufficient precision to distinguish trajectories, mechanisms, heterogeneity, and
specificity of treatment efficacy. These efforts will provide researchers with the required a priori information to
execute studies that ensure the robustness of their results. The development of these tools for RCT design will
have implications for all areas of alcohol treatment research, including in-the-moment risk behaviors, person-
level (comorbid) characteristics, targe...

## Key facts

- **NIH application ID:** 9999397
- **Project number:** 5R01AA027264-03
- **Recipient organization:** PURDUE UNIVERSITY
- **Principal Investigator:** Erin Hennes
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $671,748
- **Award type:** 5
- **Project period:** 2018-09-20 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999397

## Citation

> US National Institutes of Health, RePORTER application 9999397, Toward a Generalized Framework and Flexible Software Environment for Power Analysis of Alcohol Treatment Randomized Controlled Trials (5R01AA027264-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9999397. Licensed CC0.

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