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1.
Ann Behav Med ; 58(7): 506-516, 2024 Jun 18.
Artigo em Inglês | MEDLINE | ID: mdl-38740389

RESUMO

BACKGROUND: Affect states are posited to play a pivotal role in addiction-related processes, including tobacco lapse (i.e., smoking during a quit attempt), and distinct affective states (e.g., joy vs. happiness) may differentially influence lapse likelihood. However, few studies have examined the influence of distinct affective states on tobacco lapse. PURPOSE: This study examines the influence of 23 distinct affect states on tobacco lapse among a sample of tobacco users attempting to quit. METHODS: Participants were 220 adults who identified as African American (50% female, ages 18-74). Ecological momentary assessment was used to assess affect and lapse in real-time. Between and within-person associations testing links between distinct affect states and lapse were examined with multilevel modeling for binary outcomes. RESULTS: After adjusting for previous time's lapse and for all other positive or negative affect items, results suggested that at the between-person level, joy was associated with lower odds of lapse, and at the within-person level, attentiveness was associated with lower odds of lapse. Results also suggested that at the between-person level, guilt and nervous were associated with higher odds of lapse, and at the within-person level, shame was associated with higher odds of lapse. CONCLUSIONS: The present study uses real-time, real-world data to demonstrate the role of distinct positive and negative affects on momentary tobacco lapse. This work helps elucidate specific affective experiences that facilitate or hinder the ability to abstain from tobacco use during a quit attempt.


Assuntos
Afeto , Negro ou Afro-Americano , Avaliação Momentânea Ecológica , Abandono do Hábito de Fumar , Humanos , Feminino , Adulto , Masculino , Pessoa de Meia-Idade , Negro ou Afro-Americano/psicologia , Abandono do Hábito de Fumar/psicologia , Abandono do Hábito de Fumar/etnologia , Adulto Jovem , Adolescente , Idoso , Afeto/fisiologia , Estudos de Coortes , Felicidade
2.
Artigo em Inglês | MEDLINE | ID: mdl-38316143

RESUMO

To build a coherent knowledge base about what psychological intervention strategies work, develop interventions that have positive societal impact, and maintain and increase this impact over time, it is necessary to replace the classical treatment package research paradigm. The multiphase optimization strategy (MOST) is an alternative paradigm that integrates ideas from behavioral science, engineering, implementation science, economics, and decision science. MOST enables optimization of interventions to strategically balance effectiveness, affordability, scalability, and efficiency. In this review we provide an overview of MOST, discuss several experimental designs that can be used in intervention optimization, consider how the investigator can use experimental results to select components for inclusion in the optimized intervention, discuss the application of MOST in implementation science, and list future issues in this rapidly evolving field. We highlight the feasibility of adopting this new research paradigm as well as its potential to hasten the progress of psychological intervention science. Expected final online publication date for the Annual Review of Clinical Psychology, Volume 20 is May 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

3.
Multivariate Behav Res ; 59(1): 1-16, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-37459401

RESUMO

Sequential Multiple-Assignment Randomized Trials (SMARTs) play an increasingly important role in psychological and behavioral health research. This experimental approach enables researchers to answer scientific questions about how to sequence and match interventions to the unique, changing needs of individuals. A variety of sample size planning resources for SMART studies have been developed, enabling researchers to plan SMARTs for addressing different types of scientific questions. However, relatively limited attention has been given to planning SMARTs with binary (dichotomous) outcomes, which often require higher sample sizes relative to continuous outcomes. Existing resources for estimating sample size requirements for SMARTs with binary outcomes do not consider the potential to improve power by including a baseline measurement and/or multiple repeated outcome measurements. The current paper addresses this issue by providing sample size planning simulation procedures and approximate formulas for two-wave repeated measures binary outcomes (i.e., two measurement times for the outcome variable, before and after intervention delivery). The simulation results agree well with the formulas. We also discuss how to use simulations to calculate power for studies with more than two outcome measurement occasions. Results show that having at least one repeated measurement of the outcome can substantially improve power under certain conditions.


Assuntos
Projetos de Pesquisa , Humanos , Tamanho da Amostra
4.
JAMA ; 332(1): 21-30, 2024 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-38744428

RESUMO

Importance: Lifestyle interventions for weight loss are difficult to implement in clinical practice. Self-managed mobile health implementations without or with added support after unsuccessful weight loss attempts could offer effective population-level obesity management. Objective: To test whether a wireless feedback system (WFS) yields noninferior weight loss vs WFS plus telephone coaching and whether participants who do not respond to initial treatment achieve greater weight loss with more vs less vigorous step-up interventions. Design, Setting, and Participants: In this noninferiority randomized trial, 400 adults aged 18 to 60 years with a body mass index of 27 to 45 were randomized in a 1:1 ratio to undergo 3 months of treatment initially with WFS or WFS plus coaching at a US academic medical center between June 2017 and March 2021. Participants attaining suboptimal weight loss were rerandomized to undergo modest or vigorous step-up intervention. Interventions: The WFS included a Wi-Fi activity tracker and scale transmitting data to a smartphone app to provide daily feedback on progress in lifestyle change and weight loss, and WFS plus coaching added 12 weekly 10- to 15-minute supportive coaching calls delivered by bachelor's degree-level health promotionists viewing participants' self-monitoring data on a dashboard; step-up interventions included supportive messaging via mobile device screen notifications (app-based screen alerts) without or with coaching or powdered meal replacement. Participants and staff were unblinded and outcome assessors were blinded to treatment randomization. Main Outcomes and Measures: The primary outcome was the between-group difference in 6-month weight change, with the noninferiority margin defined as a difference in weight change of -2.5 kg; secondary outcomes included between-group differences for all participants in weight change at 3 and 12 months and between-group 6-month weight change difference among nonresponders exposed to modest vs vigorous step-up interventions. Results: Among 400 participants (mean [SD] age, 40.5 [11.2] years; 305 [76.3%] women; 81 participants were Black and 266 were White; mean [SD] body mass index, 34.4 [4.3]) randomized to undergo WFS (n = 199) vs WFS plus coaching (n = 201), outcome data were available for 342 participants (85.5%) at 6 months. Six-month weight loss was -2.8 kg (95% CI, -3.5 to -2.0) for the WFS group and -4.8 kg (95% CI, -5.5 to -4.1) for participants in the WFS plus coaching group (difference in weight change, -2.0 kg [90% CI, -2.9 to -1.1]; P < .001); the 90% CI included the noninferiority margin of -2.5 kg. Weight change differences were comparable at 3 and 12 months and, among nonresponders, at 6 months, with no difference by step-up therapy. Conclusions and Relevance: A wireless feedback system (Wi-Fi activity tracker and scale with smartphone app to provide daily feedback) was not noninferior to the same system with added coaching. Continued efforts are needed to identify strategies for weight loss management and to accurately select interventions for different individuals to achieve weight loss goals. Trial Registration: ClinicalTrials.gov Identifier: NCT02997943.


Assuntos
Tutoria , Obesidade , Redução de Peso , Humanos , Feminino , Adulto , Masculino , Pessoa de Meia-Idade , Obesidade/terapia , Terapia Comportamental/métodos , Programas de Redução de Peso/métodos , Adulto Jovem , Aplicativos Móveis , Telemedicina , Adolescente , Telefone , Tecnologia sem Fio , Monitores de Aptidão Física , Índice de Massa Corporal , Exercício Físico
5.
Behav Res Methods ; 56(3): 1770-1792, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37156958

RESUMO

Psychological interventions, especially those leveraging mobile and wireless technologies, often include multiple components that are delivered and adapted on multiple timescales (e.g., coaching sessions adapted monthly based on clinical progress, combined with motivational messages from a mobile device adapted daily based on the person's daily emotional state). The hybrid experimental design (HED) is a new experimental approach that enables researchers to answer scientific questions about the construction of psychological interventions in which components are delivered and adapted on different timescales. These designs involve sequential randomizations of study participants to intervention components, each at an appropriate timescale (e.g., monthly randomization to different intensities of coaching sessions and daily randomization to different forms of motivational messages). The goal of the current manuscript is twofold. The first is to highlight the flexibility of the HED by conceptualizing this experimental approach as a special form of a factorial design in which different factors are introduced at multiple timescales. We also discuss how the structure of the HED can vary depending on the scientific question(s) motivating the study. The second goal is to explain how data from various types of HEDs can be analyzed to answer a variety of scientific questions about the development of multicomponent psychological interventions. For illustration, we use a completed HED to inform the development of a technology-based weight loss intervention that integrates components that are delivered and adapted on multiple timescales.


Assuntos
Motivação , Projetos de Pesquisa , Humanos , Distribuição Aleatória , Emoções , Computadores de Mão
6.
Curr HIV/AIDS Rep ; 20(6): 502-512, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37924458

RESUMO

PURPOSE OF REVIEW: Recent advances in digital technologies can be leveraged to adapt HIV prevention and treatment services to the rapidly changing needs of individuals in everyday life. However, to fully take advantage of these technologies, it is critical to effectively integrate them with human-delivered components. Here, we introduce a new experimental approach for optimizing the integration and adaptation of digital and human-delivered behavioral intervention components for HIV prevention and treatment. RECENT FINDINGS: Typically, human-delivered components can be adapted on a relatively slow timescale (e.g., every few months or weeks), while digital components can be adapted much faster (e.g., every few days or hours). Thus, the systematic integration of these components requires an experimental approach that involves sequential randomizations on multiple timescales. Selecting an experimental approach should be motivated by the type of adaptive intervention investigators would like to develop, and the scientific questions they have about its construction.


Assuntos
Infecções por HIV , Projetos de Pesquisa , Humanos , Infecções por HIV/prevenção & controle , Terapia Comportamental
7.
Prev Sci ; 24(8): 1659-1671, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37060480

RESUMO

The increasing sophistication of mobile and sensing technology has enabled the collection of intensive longitudinal data (ILD) concerning dynamic changes in an individual's state and context. ILD can be used to develop dynamic theories of behavior change which, in turn, can be used to provide a conceptual framework for the development of just-in-time adaptive interventions (JITAIs) that leverage advances in mobile and sensing technology to determine when and how to intervene. As such, JITAIs hold tremendous potential in addressing major public health concerns such as cigarette smoking, which can recur and arise unexpectedly. In tandem, a growing number of studies have utilized multiple methods to collect data on a particular dynamic construct of interest from the same individual. This approach holds promise in providing investigators with a significantly more detailed view of how a behavior change processes unfold within the same individual than ever before. However, nuanced challenges relating to coarse data, noisy data, and incoherence among data sources are introduced. In this manuscript, we use a mobile health (mHealth) study on smokers motivated to quit (Break Free; R01MD010362) to illustrate these challenges. Practical approaches to integrate multiple data sources are discussed within the greater scientific context of developing dynamic theories of behavior change and JITAIs.


Assuntos
Fumar Cigarros , Abandono do Hábito de Fumar , Telemedicina , Humanos , Abandono do Hábito de Fumar/métodos , Telemedicina/métodos , Saúde Pública
8.
Pers Psychol ; 76(3): 945-975, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37745943

RESUMO

To what extent and under what conditions do college graduates disengage from employment-incompatible behaviors during the college-to-work transition? Drawing from the life course perspective, we proposed a model highlighting considerable stability of employment-incompatible behaviors during initial months of organizational socialization. Our model predicted that maturing out of such behaviors, which is expected by employers and beneficial to career adjustment, would be more likely to occur given a conducive transition context. Using a large dataset tracking graduates from their last semester in college to up to approximately 1.5 years after graduation and with alcohol use as our empirical referent, we demonstrated that a pattern of high-risk drinking behavior may remain even after the transition into full-time employment. We further showed that lower levels of perceived cohort drinking norms and higher levels of mentoring were associated with a higher probability of maturing out, manifesting in a transition from a high-risk drinking profile before graduation to a moderate drinking profile after starting full-time employment. Finally, we found that maturing out was associated with lagged outcomes including lower levels of sleep problems and depression and fewer work days lost to absenteeism, thus underscoring the consequential nature of behavior profile shifts during the college-to-work transition.

9.
J Drug Issues ; 53(1): 37-60, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38098854

RESUMO

Findings regarding the mechanism underlying the impact of supervisor incivility on subordinate alcohol misuse remain equivocal. Specifically, some studies indicate that stress mediates the impact of supervisor incivility on subordinate alcohol misuse, while others, find no evidence for such an effect, suggesting the need to investigate other mechanisms. Extending Conservation of Resource (COR) theory and employing a longitudinal study design, this study examines two alternative mechanisms grounded on social isolation. The first suggests drinking as a resource-mobilizing response, with social isolation eliciting the perception of more permissive injunctive drinking norms, thus facilitating problematic drinking. The second suggests problematic drinking as a mode of coping with a negative emotional state elicited by social isolation, namely depression. Findings indicate that supervisor undermining's association with subsequent subordinate problematic drinking is serially mediated by social isolation and depression, with no support found for the first mechanism. Implications for research, practice and policy are discussed.

10.
Biostatistics ; 21(3): 432-448, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-30380020

RESUMO

Sequential, multiple assignment, randomized trial (SMART) designs have become increasingly popular in the field of precision medicine by providing a means for comparing more than two sequences of treatments tailored to the individual patient, i.e., dynamic treatment regime (DTR). The construction of evidence-based DTRs promises a replacement to ad hoc one-size-fits-all decisions pervasive in patient care. However, there are substantial statistical challenges in sizing SMART designs due to the correlation structure between the DTRs embedded in the design (EDTR). Since a primary goal of SMARTs is the construction of an optimal EDTR, investigators are interested in sizing SMARTs based on the ability to screen out EDTRs inferior to the optimal EDTR by a given amount which cannot be done using existing methods. In this article, we fill this gap by developing a rigorous power analysis framework that leverages the multiple comparisons with the best methodology. Our method employs Monte Carlo simulation to compute the number of individuals to enroll in an arbitrary SMART. We evaluate our method through extensive simulation studies. We illustrate our method by retrospectively computing the power in the Extending Treatment Effectiveness of Naltrexone (EXTEND) trial. An R package implementing our methodology is available to download from the Comprehensive R Archive Network.


Assuntos
Pesquisa Biomédica , Modelos Estatísticos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Pesquisa Biomédica/métodos , Pesquisa Biomédica/normas , Humanos , Método de Monte Carlo , Naltrexona/farmacologia , Avaliação de Resultados em Cuidados de Saúde/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Tamanho da Amostra
11.
J Child Psychol Psychiatry ; 62(8): 1019-1031, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33590475

RESUMO

BACKGROUND: The need for effective interventions for psychiatrically hospitalized adolescents who have varying levels of postdischarge suicide risk calls for personalized approaches, such as adaptive interventions (AIs). We conducted a nonrestricted pilot Sequential, Multiple Assignment, Randomized Trial (SMART) to guide the development of an AI targeting suicide risk after hospitalization. METHODS: Adolescent inpatients (N = 80; ages 13-17; 67.5% female) were randomized in Phase 1 to a Motivational Interview-Enhanced Safety Plan (MI-SP), delivered during hospitalization, alone or in combination with postdischarge text-based support (Texts). Two weeks after discharge, participants were re-randomized in Phase 2 to added telephone booster calls or to no calls. Mechanisms of change were assessed with daily diaries for four weeks and over a 1- and 3-month follow-up. This trial is registered with clinicaltrials.gov (identifier: NCT03838198). RESULTS: Procedures were feasible and acceptable. Mixed effects models indicate that adolescents randomized to MI-SP + Texts (Phase 1) and those randomized to booster calls (Phase 2) experienced significant improvement in daily-level mechanisms, including safety plan use, self-efficacy to refrain from suicidal action, and coping by support seeking. Those randomized to MI-SP + Texts also reported significantly higher coping self-efficacy at 1 and 3 months. Although exploratory, results were in the expected direction for MI-SP + Texts, versus MI-SP alone, in terms of lower risk of suicide attempts (Hazard ratio = 0.30; 95% CI = 0.06, 1.48) and suicidal behavior (Hazard ratio = 0.36; 95% CI = 0.10, 1.37) three months after discharge. Moreover, augmentation with booster calls did not have an overall meaningful impact on suicide attempts (Hazard ratio = 0.65; 95% CI = 0.17, 3.05) or suicidal behavior (Hazard ratio = 0.78; 95% CI = 0.23, 2.67); however, boosters benefited most those initially assigned to MI-SP + Texts. CONCLUSIONS: The current SMART was feasible and acceptable for the purpose of informing an AI for suicidal adolescents, warranting additional study. Findings also indicate that postdischarge text-based support offers a promising augmentation to safety planning delivered during hospitalization.


Assuntos
Comportamento do Adolescente , Ideação Suicida , Adolescente , Assistência ao Convalescente , Feminino , Hospitalização , Humanos , Masculino , Alta do Paciente , Tentativa de Suicídio
12.
Subst Use Misuse ; 56(14): 2115-2125, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34499570

RESUMO

ABBREVIATIONS: JITAI: Just-in-time adaptive intervention; ROC: receiver operating characteristic; AUC: area under the curve; MRT: micro-randomized trial.


Assuntos
Consumo de Bebidas Alcoólicas , Adulto , Consumo de Bebidas Alcoólicas/prevenção & controle , Humanos , Curva ROC
13.
Except Child ; 88(1): 8-25, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36468153

RESUMO

This article introduces the special section on adaptive interventions and sequential multiple-assignment randomized trial (SMART) research designs. In addition to describing the two accompanying articles, we discuss features of adaptive interventions (AIs) and describe the use of SMART design to optimize AIs in the context of multitiered systems of support (MTSS) and integrated MTSS. AI is a treatment delivery model that explicitly specifies how information about individuals should be used to decide which treatment to provide in practice. Principles that apply to the design of AIs may help to more clearly operationalize MTSS-based programs, improve their implementation in school settings, and increase their efficacy when used according to evidence-based decision rules. A SMART is a research design for developing and optimizing MTSS-based programs. We provide a running example of a SMART design to optimize an MTSS-aligned AI that integrates academic and behavioral interventions.

14.
BMC Psychiatry ; 19(1): 424, 2019 12 28.
Artigo em Inglês | MEDLINE | ID: mdl-31883526

RESUMO

BACKGROUND: Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. METHODS/DESIGN: We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up. DISCUSSION: The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability. TRIAL REGISTRATION: ClinicalTrials.gov NCT03466346, registered March 15, 2018.


Assuntos
Antidepressivos de Segunda Geração/administração & dosagem , Transtorno Depressivo Maior/terapia , Fluoxetina/administração & dosagem , Serviços de Saúde Mental , Psicoterapia/métodos , Transtornos de Estresse Pós-Traumáticos/terapia , Adulto , Assistência Ambulatorial/métodos , Assistência Ambulatorial/tendências , Instituições de Assistência Ambulatorial/tendências , Terapia Combinada/métodos , Terapia Combinada/tendências , Prestação Integrada de Cuidados de Saúde/métodos , Prestação Integrada de Cuidados de Saúde/tendências , Transtorno Depressivo Maior/epidemiologia , Transtorno Depressivo Maior/psicologia , Feminino , Hospitais de Condado/tendências , Humanos , Quênia/epidemiologia , Masculino , Serviços de Saúde Mental/tendências , Setor Público/tendências , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos de Estresse Pós-Traumáticos/psicologia , Resultado do Tratamento
15.
Multivariate Behav Res ; 54(5): 613-636, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30663401

RESUMO

Sequential multiple assignment randomized trials (SMARTs) are a useful and increasingly popular approach for gathering information to inform the construction of adaptive interventions to treat psychological and behavioral health conditions. Until recently, analysis methods for data from SMART designs considered only a single measurement of the outcome of interest when comparing the efficacy of adaptive interventions. Lu et al. proposed a method for considering repeated outcome measurements to incorporate information about the longitudinal trajectory of change. While their proposed method can be applied to many kinds of outcome variables, they focused mainly on linear models for normally distributed outcomes. Practical guidelines and extensions are required to implement this methodology with other types of repeated outcome measures common in behavioral research. In this article, we discuss implementation of this method with repeated binary outcomes. We explain how to compare adaptive interventions in terms of various summaries of repeated binary outcome measures, including average outcome (area under the curve) and delayed effects. The method is illustrated using an empirical example from a SMART study to develop an adaptive intervention for engaging alcohol- and cocaine-dependent patients in treatment. Monte Carlo simulations are provided to demonstrate the good performance of the proposed technique.


Assuntos
Ensaios Clínicos Adaptados como Assunto/métodos , Análise de Dados , Estudos Longitudinais , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Interpretação Estatística de Dados , Humanos , Projetos de Pesquisa
16.
Hum Relat ; 72(4): 675-705, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30905973

RESUMO

While it is well established that workplace demands and culture can affect employee well-being, to what degree might these same factors have lingering implications on individual wellbeing after employees retire? To begin to answer this question, in this paper we propose and test a model explaining how retiree alcohol consumption may depend on pre-retirement contextual conditions. Specifically, we propose and test a moderated-mediation model in which two ambient work unit characteristics-work-unit stress climate and work-unit drinking norms-moderate the indirect effects of retirement, via distress, on modal alcohol consumption (i.e., the typical quantity and frequency of alcohol consumed). Using a prospective study design and a multi-level, zero-inflated negative binomial model for predicting modal alcohol consumption, our findings lend partial support for the proposed model. We found retirement (vs. continued employment) to be associated with a heightened probability of being an abstainer after retirement eligibility (i.e., at Time 2), regardless of the hypothesized unit-level moderators. Still, retirement had mixed effects on the level of modal consumption among those not abstaining at Time 2, with these effects being partially mediated by distress and contingent upon unit-level stress climate and unit-level drinking norms.

17.
Ann Behav Med ; 52(6): 446-462, 2018 05 18.
Artigo em Inglês | MEDLINE | ID: mdl-27663578

RESUMO

Background: The just-in-time adaptive intervention (JITAI) is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual's changing internal and contextual state. The availability of increasingly powerful mobile and sensing technologies underpins the use of JITAIs to support health behavior, as in such a setting an individual's state can change rapidly, unexpectedly, and in his/her natural environment. Purpose: Despite the increasing use and appeal of JITAIs, a major gap exists between the growing technological capabilities for delivering JITAIs and research on the development and evaluation of these interventions. Many JITAIs have been developed with minimal use of empirical evidence, theory, or accepted treatment guidelines. Here, we take an essential first step towards bridging this gap. Methods: Building on health behavior theories and the extant literature on JITAIs, we clarify the scientific motivation for JITAIs, define their fundamental components, and highlight design principles related to these components. Examples of JITAIs from various domains of health behavior research are used for illustration. Conclusions: As we enter a new era of technological capacity for delivering JITAIs, it is critical that researchers develop sophisticated and nuanced health behavior theories capable of guiding the construction of such interventions. Particular attention has to be given to better understanding the implications of providing timely and ecologically sound support for intervention adherence and retention.


Assuntos
Medicina do Comportamento/métodos , Comportamentos Relacionados com a Saúde , Cooperação do Paciente , Projetos de Pesquisa , Telemedicina/métodos , Humanos
18.
Biostatistics ; 17(1): 135-48, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26243172

RESUMO

A dynamic treatment regime (DTR) is a treatment design that seeks to accommodate patient heterogeneity in response to treatment. DTRs can be operationalized by a sequence of decision rules that map patient information to treatment options at specific decision points. The sequential, multiple assignment, randomized trial (SMART) is a trial design that was developed specifically for the purpose of obtaining data that informs the construction of good (i.e. efficacious) decision rules. One of the scientific questions motivating a SMART concerns the comparison of multiple DTRs that are embedded in the design. Typical approaches for identifying the best DTRs involve all possible comparisons between DTRs that are embedded in a SMART, at the cost of greatly reduced power to the extent that the number of embedded DTRs (EDTRs) increase. Here, we propose a method that will enable investigators to use SMART study data more efficiently to identify the set that contains the most efficacious EDTRs. Our method ensures that the true best EDTRs are included in this set with at least a given probability. Simulation results are presented to evaluate the proposed method, and the Extending Treatment Effectiveness of Naltrexone SMART study data are analyzed to illustrate its application.


Assuntos
Interpretação Estatística de Dados , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Humanos
19.
Stat Med ; 35(10): 1595-615, 2016 May 10.
Artigo em Inglês | MEDLINE | ID: mdl-26638988

RESUMO

A dynamic treatment regime (DTR) is a sequence of decision rules, each of which recommends a treatment based on a patient's past and current health status. Sequential, multiple assignment, randomized trials (SMARTs) are multi-stage trial designs that yield data specifically for building effective DTRs. Modeling the marginal mean trajectories of a repeated-measures outcome arising from a SMART presents challenges, because traditional longitudinal models used for randomized clinical trials do not take into account the unique design features of SMART. We discuss modeling considerations for various forms of SMART designs, emphasizing the importance of considering the timing of repeated measures in relation to the treatment stages in a SMART. For illustration, we use data from three SMART case studies with increasing level of complexity, in autism, child attention deficit hyperactivity disorder, and adult alcoholism. In all three SMARTs, we illustrate how to accommodate the design features along with the timing of the repeated measures when comparing DTRs based on mean trajectories of the repeated-measures outcome.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Estatística como Assunto , Adolescente , Adulto , Alcoolismo/terapia , Transtorno do Deficit de Atenção com Hiperatividade/terapia , Transtorno Autístico/terapia , Criança , Pré-Escolar , Humanos , Resultado do Tratamento
20.
J Clin Child Adolesc Psychol ; 45(4): 442-56, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26954267

RESUMO

There are limited data on the effects of adaptive social communication interventions with a speech-generating device in autism. This study is the first to compare growth in communications outcomes among three adaptive interventions in school-age children with autism spectrum disorder (ASD) who are minimally verbal. Sixty-one children, ages 5-8 years, participated in a sequential, multiple-assignment randomized trial (SMART). All children received a developmental behavioral communication intervention: joint attention, symbolic play, engagement and regulation (JASP) with enhanced milieu teaching (EMT). The SMART included three 2-stage, 24-week adaptive interventions with different provisions of a speech-generating device (SGD) in the context of JASP+EMT. The first adaptive intervention, with no SGD, initially assigned JASP+EMT alone, then intensified JASP+EMT for slow responders. In the second adaptive intervention, slow responders to JASP+EMT were assigned JASP+EMT+SGD. The third adaptive intervention initially assigned JASP+EMT+SGD; then intensified JASP+EMT+SGD for slow responders. Analyses examined between-group differences in change in outcomes from baseline to Week 36. Verbal outcomes included spontaneous communicative utterances and novel words. Nonlinguistic communication outcomes included initiating joint attention and behavior regulation, and play. The adaptive intervention beginning with JASP+EMT+SGD was estimated as superior. There were significant (p < .05) between-group differences in change in spontaneous communicative utterances and initiating joint attention. School-age children with ASD who are minimally verbal make significant gains in communication outcomes with an adaptive intervention beginning with JASP+EMT+SGD. Future research should explore mediators and moderators of the adaptive intervention effects and second-stage intervention options that further capitalize on early gains in treatment.


Assuntos
Transtorno do Espectro Autista/psicologia , Transtorno do Espectro Autista/terapia , Transtornos Globais do Desenvolvimento Infantil/psicologia , Transtornos Globais do Desenvolvimento Infantil/terapia , Auxiliares de Comunicação para Pessoas com Deficiência/tendências , Comportamento Verbal/fisiologia , Atenção/fisiologia , Transtorno do Espectro Autista/diagnóstico , Criança , Transtornos Globais do Desenvolvimento Infantil/diagnóstico , Pré-Escolar , Comunicação , Auxiliares de Comunicação para Pessoas com Deficiência/estatística & dados numéricos , Feminino , Humanos , Estudos Longitudinais , Masculino , Fala/fisiologia , Resultado do Tratamento
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