A "SMART" design for building individualized treatment sequences

Abstract

Interventions often involve a sequence of decisions. For example, clinicians frequently adapt the intervention to an individual's outcomes. Altering the intensity and type of intervention over time is crucial for many reasons, such as to obtain improvement if the individual is not responding or to reduce costs and burden when intensive treatment is no longer necessary. Adaptive interventions utilize individual variables (severity, preferences) to adapt the intervention and then dynamically utilize individual outcomes (response to treatment, adherence) to readapt the intervention. The Sequential Multiple Assignment Randomized Trial (SMART) provides high-quality data that can be used to construct adaptive interventions. We review the SMART and highlight its advantages in constructing and revising adaptive interventions as compared to alternative experimental designs. Selected examples of SMART studies are described and compared. A data analysis method is provided and illustrated using data from the Extending Treatment Effectiveness of Naltrexone SMART study.

Figures

Figure 1

Flow chart of the Adaptive Drug Court Program. ICM, intensive case management.

Figure 2

Design of the adaptive Reinforcement-Based Treatment (RBT) Trial (H. Jones, P.I.). aRBT, abbreviated RBT; eRBT, enhanced RBT; rRBT, reduced RBT; tRBT, treatment-as-usual RBT.

Figure 3

The Characterizing Cognition in Nonverbal Individuals with Autism Trial design (C. Kasari, P.I.). AAC, augmentative and alternative communication; EMT, enhanced milieu teaching; JAE, joint attention/joint engagement.

Figure 4

Design of the Adaptive Pharmacological and Behavioral Treatments for Children with ADHD Trial (W. Pelham, P.I.). BMOD, behavior modification; MEDS, low-dose medication.

Figure 5

The Extending Treatment Effectiveness of Naltrexone (ExTENd) Trial design (D. Oslin, P.I.). CBI, combined behavioral intervention; MM, medical management; NTX, naltrexone; TDM, telephone disease management.