OBJECTIVE: Developing evidenced-based practices for the management of childhood psychiatric disorders requires research studies that address how to treat children during both the acute phase of the disorder and beyond. Given the selection of a medication for acute treatment, discontinuation trials are used to evaluate the effects of treatment duration (e.g., time on medication) and/or maintenance strategies following successful acute-phase treatment. Recently, sequential multiple assignment randomized trials (SMART) have been proposed for use in informing sequences of critical clinical decisions such as those mentioned. The objective of this article is to illustrate how a SMART study is related to the standard discontinuation trial design, while addressing additional clinically important questions with similar trial resources. METHOD: The recently completed Child/Adolescent Anxiety Multimodal Study (CAMS), a randomized trial that examined the relative efficacy of three acute-phase treatments for pediatric anxiety disorders, along with a next logical step, a standard discontinuation trial design, is used to clarify the ideas. This example is used to compare the discontinuation trial design relative to the SMART design. RESULTS: We find that the standard discontinuation trial can be modified slightly using a SMART design to yield high-quality data that can be used to address a wider variety of questions in addition to the impact of treatment duration. We discuss how this innovative trial design is ultimately more efficient and less costly than the standard discontinuation trial, and may result in more representative comparisons between treatments. CONCLUSIONS: Mental health researchers who are interested in addressing questions concerning the effects of continued treatment (for different durations) following successful acute-phase treatment should consider SMART designs in place of discontinuation trial designs in their research. SMART designs can be used to address these and other questions concerning individualized sequences of treatment, such as the choice of a rescue treatment in case of postacute phase relapse.
OBJECTIVE: Developing evidenced-based practices for the management of childhood psychiatric disorders requires research studies that address how to treat children during both the acute phase of the disorder and beyond. Given the selection of a medication for acute treatment, discontinuation trials are used to evaluate the effects of treatment duration (e.g., time on medication) and/or maintenance strategies following successful acute-phase treatment. Recently, sequential multiple assignment randomized trials (SMART) have been proposed for use in informing sequences of critical clinical decisions such as those mentioned. The objective of this article is to illustrate how a SMART study is related to the standard discontinuation trial design, while addressing additional clinically important questions with similar trial resources. METHOD: The recently completed Child/Adolescent Anxiety Multimodal Study (CAMS), a randomized trial that examined the relative efficacy of three acute-phase treatments for pediatric anxiety disorders, along with a next logical step, a standard discontinuation trial design, is used to clarify the ideas. This example is used to compare the discontinuation trial design relative to the SMART design. RESULTS: We find that the standard discontinuation trial can be modified slightly using a SMART design to yield high-quality data that can be used to address a wider variety of questions in addition to the impact of treatment duration. We discuss how this innovative trial design is ultimately more efficient and less costly than the standard discontinuation trial, and may result in more representative comparisons between treatments. CONCLUSIONS: Mental health researchers who are interested in addressing questions concerning the effects of continued treatment (for different durations) following successful acute-phase treatment should consider SMART designs in place of discontinuation trial designs in their research. SMART designs can be used to address these and other questions concerning individualized sequences of treatment, such as the choice of a rescue treatment in case of postacute phase relapse.
Authors: Hans-Ulrich Wittchen; Ron C Kessler; Katja Beesdo; Petra Krause; Michael Höfler; Jürgen Hoyer Journal: J Clin Psychiatry Date: 2002 Impact factor: 4.384
Authors: Graham J Emslie; Beth D Kennard; Taryn L Mayes; Jeanne Nightingale-Teresi; Thomas Carmody; Carroll W Hughes; A John Rush; Rongrong Tao; Jeanne W Rintelmann Journal: Am J Psychiatry Date: 2008-02-15 Impact factor: 18.112
Authors: Peter F Thall; Christopher Logothetis; Lance C Pagliaro; Sijin Wen; Melissa A Brown; Dallas Williams; Randall E Millikan Journal: J Natl Cancer Inst Date: 2007-10-30 Impact factor: 13.506
Authors: Sean Grant; Denis Agniel; Daniel Almirall; Q Burkhart; Sarah B Hunter; Daniel F McCaffrey; Eric R Pedersen; Rajeev Ramchand; Beth Ann Griffin Journal: Addict Sci Clin Pract Date: 2017-12-19
Authors: Dana Steidtmann; Rachel Manber; Christine Blasey; John C Markowitz; Daniel N Klein; Barbara O Rothbaum; Michael E Thase; James H Kocsis; Bruce A Arnow Journal: J Consult Clin Psychol Date: 2013-06-10
Authors: Connie Kasari; Ann Kaiser; Kelly Goods; Jennifer Nietfeld; Pamela Mathy; Rebecca Landa; Susan Murphy; Daniel Almirall Journal: J Am Acad Child Adolesc Psychiatry Date: 2014-03-12 Impact factor: 8.829
Authors: Erika L Crable; Thomas R Blue; Michelle McKenzie; Josiah D Rich; Michael S Gordon Journal: J Acquir Immune Defic Syndr Date: 2021-05-01 Impact factor: 3.771