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

Award Number: R01AA027264
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Toward a Generalized Framework and Flexible Software Environment for Power Analysis of Alcohol Treatment Randomized Controlled Trials - 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, targeting underserved and vulnerable populations, and large-scale initiatives. As a result, this proposal will allow for more definitive identification of efficacious interventions and treatments of alcohol use disorder.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	UNIVERSITY OF MISSOURI SYSTEM	121 UNIVERSITY HALL	COLUMBIA	MO	65211	BOONE	USA	Alcohol Research Programs	002	6	9/20/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2022	UNIVERSITY OF MISSOURI SYSTEM	121 UNIVERSITY HALL	COLUMBIA	MO	65211	BOONE	USA	Alcohol Research Programs	001	6	5/22/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$422
2024	2021	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE # 1100	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Alcohol Research Programs	000	4	5/22/2024	NON-COMPETING CONTINUATION	-$422
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE STE 1900	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Alcohol Research Programs	000	5	5/11/2023	NON-COMPETING CONTINUATION	-$671,748
2023	2022	UNIVERSITY OF MISSOURI SYSTEM	121 UNIVERSITY HALL	COLUMBIA	MO	65211	BOONE	USA	Alcohol Research Programs	002	6	7/25/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2023	2022	UNIVERSITY OF MISSOURI SYSTEM	121 UNIVERSITY HALL	COLUMBIA	MO	65211	BOONE	USA	Alcohol Research Programs	001	6	5/12/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$671,748
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $671,748 )
2022	2022	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE STE 1900	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Alcohol Research Programs	000	5	8/20/2022	NON-COMPETING CONTINUATION	$671,748
														Subtotal = $671,748

Issue Date FY: 2021 ( Subtotal = $671,748 )
2021	2021	PURDUE UNIVERSITY	155 S GRANT ST	WEST LAFAYETTE	IN	47907	TIPPECANOE	USA	Alcohol Research Programs	000	4	8/9/2021	NON-COMPETING CONTINUATION	$671,748
														Subtotal = $671,748

Issue Date FY: 2020 ( Subtotal = $671,748 )
2020	2020	PURDUE UNIVERSITY	155 S GRANT ST	WEST LAFAYETTE	IN	47907	TIPPECANOE	USA	Alcohol Research Programs	000	3	8/17/2020	NON-COMPETING CONTINUATION	$671,748
														Subtotal = $671,748

Issue Date FY: 2019 ( Subtotal = $680,219 )
2019	2019	PURDUE UNIVERSITY	155 S GRANT ST	WEST LAFAYETTE	IN	47907	TIPPECANOE	USA	Alcohol Research Programs	000	2	8/20/2019	NON-COMPETING CONTINUATION	$680,219
														Subtotal = $680,219

Issue Date FY: 2018 ( Subtotal = $715,938 )
2018	2018	PURDUE UNIVERSITY	401 SOUTH GRANT ST	WEST LAFAYETTE	IN	47907	TIPPECANOE	USA	Alcohol Research Programs	000	1	9/18/2018	NEW	$715,938
														Subtotal = $715,938

Grand Total All Awards = $3,411,401

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

Award Number: R01AA027264

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/20/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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