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Behavioral Intervention Research: Designing, Evaluating, and Implementing


PREFACEI DEVELOPING INTERVENTIONS: HEART OF THE MATTERPROMISES AND CHALLENGES OF BEHAVIORAL INTERVENTION RESEARCHWHY BEHAVIORAL INTERVENTION RESEARCH IS IMPORTANTADVANCEMENTS IN BEHAVIORAL INTERVENTION RESEARCHCASE EXEMPLARSRELATIONSHIP OF BEHAVIORAL INTERVENTION RESEARCH TO IMPLEMENTATION SCIENCECHALLENGES OF BEHAVIORAL INTERVENTION RESEARCHCONCEPTUAL FRAMEWORKROADMAPREFERENCESPIPELINES FOR DESIGNING, EVALUATING, AND IMPLEMENTING INTERVENTIONSPIPELINE AS A HEURISTICTRADITIONAL PIPELINEPhase I—Feasibility, Proof of ConceptPhase II—Initial Comparison With a Control GroupPhase III—EfficacyPhase IV—EffectivenessDetermining Whether Further Testing Is RequiredNational Institutes of Health Designation of Research PhasesELONGATED PIPELINEPhase V—Translation/ImplementationMethodologiesPhase VI—DisseminationPhase VII—SustainabilityAdvantage of the Elongated PipelineSTRATEGIES FOR ACCELERATING INTERVENTION DEVELOPMENTAlign Targets With Research StudiesIdentify Key StakeholdersIdentify ContextCost the InterventionImprove Delivery EfficienciesEnhance Design EfficienciesRECONSTRUCTING THE PIPELINECONCLUSIONREFERENCESGETTING STARTED—ANATOMY OF THE INTERVENTIONGETTING STARTEDDefine the ProblemQuantify the ProblemSpecify the Populations Most at Risk for the Identified ProblemDetermine the Pathways by Which the Identified Problem OccursDetermine If Pathways Are ModifiableSpecify Potential OutcomesQuantify the Potential for ImprovementDetermine How the Problem Is Currently Being AddressedSOURCES INFORMING DISCOVERYMAPPING AN INTERVENTIONSESSION-BY-SESSION DETAILSProblem Behaviors of Dementia DisordersCONCLUSIONREFERENCESTHEORY: A DRIVER OF BEHAVIORAL INTERVENTION RESEARCHWHAT IS THEORY?DEDUCTIVE REASONING APPROACHROLE OF THEORY ALONG THE PIPELINEDevelopment PhasesWhy an Intervention May WorkSelecting Delivery CharacteristicsEvaluation PhasesImplementation PhasesSELECTING A THEORY OR CONCEPTUAL FRAMEWORKCOMMONLY USED THEORIES IN BEHAVIORAL INTERVENTION RESEARCHUSING MORE THAN ONE THEORYCHALLENGES USING THEORYCONCLUSIONREFERENCESDELIVERY CHARACTERISTICS OF BEHAVIORAL INTERVENTIONSWHERE TO BEGIN: HELPING TO SHAPE THE TOPICFUNDAMENTAL INTERVENTION DELIVERY CHARACTERISTICSTreatment ContentTreatment Dosage and DurationDelivery Modality and SettingDelivery ModalityDelivery SettingDelivery ApproachStaffing IssuesCHARACTERISTICS OF AN EFFECTIVE DELIVERY APPROACHCONCLUSIONREFERENCESSTANDARDIZATIONWHY IS STANDARDIZATION IMPORTANT?WHAT NEEDS TO BE STANDARDIZED?TAILORING OF INTERVENTIONSSTRATEGIES TO ENHANCE STANDARDIZATIONManual of OperationSelection and Training of Team MembersOther Strategies to Enhance StandardizationCONCLUSIONREFERENCESTHE USE OF TECHNOLOGY IN BEHAVIORAL INTERVENTION RESEARCH: ADVANTAGES AND CHALLENGESTECHNOLOGY AND BEHAVIORAL INTERVENTIONSTelephone and Videoconferencing TechnologiesMobile TechnologiesInternet-Based InterventionsOther Emerging Technology ApplicationsPotential Advantages and Challenges With Technology-Based Intervention ApproachesAdherenceEvolution of TechnologySkeuomorphismOther ChallengesTHE APPLICATION OF TECHNOLOGY IN DATA COLLECTION AND ANALYSISCONCLUSIONREFERENCESII VALUATING INTERVENTIONS: ATTENTION TO DESIGNSELECTING CONTROL GROUPS: TO WHAT SHOULD WE COMPARE BEHAVIORAL INTERVENTIONS?WHEN AND WHY TO INCLUDE A CONTROL GROUPWHY CONTROL GROUPS ARE IMPORTANT FOR THE RCT PHASESTYPES OF CONTROL GROUPS FOR RCTsOTHER TYPES OF CONTROL CONDITIONSEXISTING PRACTICE COMPARISON CONDITIONSSELECTING CONTROL GROUPS: SAMPLE CASE OF COGNITIVE INTERVENTION TRIALSCONTAMINATION EFFECTSETHICAL ISSUES IN THE SELECTION AND USE OF CONTROL GROUPSIMPACT ON RECRUITMENT AND ATTRITIONRECOMMENDATIONS AND CONCLUSIONSREFERENCESSAMPLING CONSIDERATIONS: IDENTIFYING APPROPRIATE PARTICIPANTS FOR BEHAVIORAL INTERVENTION RESEARCHSAMPLE CHARACTERISTICSSample CompositionSample SizeSAMPLING METHODSProbability SamplingRandom SamplingSystematic SamplingStratified SamplingCluster SamplingNonprobability Sampling TechniquesConvenience SamplingQuota SamplingPurposive SamplingSnowball SamplingAdaptive Allocation SamplingCONCLUSIONS AND GENERAL RECOMMENDATIONSREFERENCESRECRUITMENT AND RETENTION: TWO OF THE MOST IMPORTANT, YET CHALLENGING, TASKS IN BEHAVIORAL INTERVENTION RESEARCHCOMMON ISSUES WITH RECRUITING STUDY PARTICIPANTSChallenges to RecruitmentLack of PlanningStudy-Related FactorsParticipant FactorsContextual FactorsCOMMON ISSUES IN RETENTIONSTRATEGIES TO ENHANCE RECRUITMENT AND RETENTIONGeneral StrategiesMethods of RecruitmentPlanning for Recruitment and RetentionRecommendation 1: Conduct an Analysis of the Environment, the Target Population, and the InterventionRecommendation 2: Establish a Recruitment Timeline and Identify Recruitment StaffRecommendation 3: Develop a Recruitment and Retention DatabaseRecommendation 4: Adopt a Community-Based Participatory Research Approach for Recruitment and RetentionRecommendation 5: Establish a Community Advisory BoardRecommendation 6: Build Trust With the Community/Target PopulationRecommendation 7: Minimize Potential Inconveniences Associated With Study ParticipationRecommendation 8: Pilot Test Recruitment Materials and MethodsCONCLUSIONREFERENCESMIXED METHODS IN BEHAVIORAL INTERVENTION RESEARCHWHAT ARE MIXED METHODS?WHY USE MIXED METHODS TO DEVELOP AND EVALUATE BEHAVIORAL INTERVENTIONS?WHAT ARE KEY MIXED METHODS DESIGNS?Exploratory Sequential DesignExplanatory Sequential DesignsConcurrent DesignsSamplingMIXED METHODS IN THE INTERVENTION PIPELINEEXAMPLES OF MIXED METHODS APPROACHES IN THE INTERVENTION DEVELOPMENT PIPELINEIntervention DevelopmentWithin a Randomized TrialImplementation StudiesUnderstanding OutcomesCHALLENGES IN MIXED METHODS RESEARCHCONCLUSIONREFERENCESARE TREATMENT EFFECTS REAL? THE ROLE OF FIDELITYEVOLUTION AND HISTORICAL USES OF THE CONSTRUCT OF FIDELITYFIDELITY CONSIDERATIONS ALONG THE INTERVENTION PIPELINEDEVELOPING A FIDELITY PLANStrategies for Assuring Study Design IntegrityStrategies for DeliveryStrategies for ReceiptStrategies for EnactmentCONSIDERATIONS IN DEVELOPING A FIDELITY PLANCHALLENGES IN ENHANCING, MONITORING, AND MEASURING FIDELITYCONCLUSIONREFERENCESETHICAL CONSIDERATIONS IN BEHAVIORAL INTERVENTION RESEARCHFUNDAMENTALS OF ETHICAL CONDUCT IN RESEARCHEthical Conduct in the Research ProcessEthical Responsibilities of the Principal InvestigatorINFORMED CONSENTINSTITUTIONAL REVIEW BOARDSADVERSE EVENTSDATA AND SAFETY-MONITORING BOARDSCONCLUSIONREFERENCESIII DOES THE INTERVENTION WORK? SELECTING OUTCOMES AND ANALYTICSMEASUREMENT IN BEHAVIORAL INTERVENTION RESEARCHTHE ROLE OF MEASURES IN BEHAVIORAL INTERVENTION RESEARCHCATEGORIES AND TYPES OF MEASURESTYPES OF MEASURES Individual-Level MeasuresCommunity/Organization-Level MeasuresMETHODS OF DATA COLLECTIONSELECTION CRITERIAPsychometric Properties and Scale of MeasurementLevel of MeasurementReliabilityValiditySensitivity and SpecificityAdditional ConsiderationsTHE ROLE OF TECHNOLOGY IN MEASUREMENTA CAUTIONARY NOTE: INCORRECT INTERPRETATIONS OF OUTCOME MEASURESCONCLUSIONREFERENCESCOGNITIVE AND FUNCTIONAL OUTCOMES: THE ROLE OF OBJECTIVE MEASUREMENTWHY USE PERFORMANCE-BASED MEASURES?THE LIMITATIONS OF SELF-REPORT AS AN OUTCOME MEASUREDEFINING THE CONSTRUCTS OF COGNITION AND FUNCTIONAL PERFORMANCEMEASUREMENT STRATEGIES FOR EVALUATING COGNITIVE AND FUNCTIONAL PERFORMANCEInformant MeasuresPERFORMANCE-BASED ASSESSMENTSHistory of Performance-Based Assessment MeasuresStandard Neuropsychological Tests of CognitionFactors to Consider in Selecting a Cognitive Assessment BatteryBreadth of the Assessment BatteryDuration of the AssessmentFormat of the AssessmentFrequency of Assessments and Practice EffectsInterview-Based Assessments of CognitionMeasures of Functional Skills/PerformanceImportance of Milestones and Consideration of Subthreshold Performance to AssessmentEcological Momentary Assessment TechniquesFunctional Capacity MeasuresSome Unique ConsiderationsCognition or Capacity as the OutcomeWhat Defines Improvement?Practical ConcernsRealistic Assessment StrategiesCONCLUSIONREFERENCESSTATISTICS IS NOT A SUBSTITUTE FOR SOLID EXPERIMENTAL METHODOLOGY AND DESIGNSELECTION OF RELIABLE AND VALID STUDY VARIABLESScales of MeasurementEstablishing CausalityMEDIATING AND MODERATING EFFECTSSTATISTICAL SIGNIFICANCE VERSUS PRACTICAL IMPORTANCEPLANNED COMPARISONS VERSUS POST HOC COMPARISONSMeasurement Over TimeMultilevel ModelingMissing DataStructural Equation ModelingCONCLUSIONREFERENCESCLINICAL SIGNIFICANCETHE MEANING AND MEASUREMENT OF CLINICAL SIGNIFICANCEDefining Clinical SignificanceMeasuring Clinical SignificanceComparison ApproachesNumber Needed to Treat and Number Needed to HarmSubjective EvaluationsQuality of LifeSocial Impact MeasuresSTRATEGIES FOR MAXIMIZING THE CLINICAL SIGNIFICANCE OF INTERVENTION PROGRAMSCONCLUSIONREFERENCESECONOMIC EVALUATIONS OF BEHAVIORAL INTERVENTIONSWHY COSTING INTERVENTIONS IS IMPORTANTSTEPS IN AN ECONOMIC EVALUATIONStep 1: Determine the Primary Adopter of the InterventionStep 2: Choose the Method of Economic EvaluationStep 3: Select the Appropriate Type of AnalysisCost StudyCost-Effectiveness AnalysisCost-Utility AnalysisCost-Minimization AnalysisCost-Benefit AnalysisStep 4: Identify and Measure Specific Costs and OutcomesIntervention CostsHealth Care and Non-Health Care CostsSources of Cost DataConverting Health Care Utilization to Health Care CostsDiscounting Future CostsOutcome MeasuresStep 5: Complete the Economic Evaluation and Sensitivity AnalysisStep 6: Communicate the FindingsCHALLENGES IN CONDUCTING ECONOMIC EVALUATIONSTime HorizonStatistical PowerDATA COLLECTION CONSIDERATIONS Using Self-Reported DataUsing Health Care Statements or Claims DataCONCLUSIONREFERENCESIV INTO THE REAL WORLD: IMPLEMENTATION AND DISSEMINATIONTHE ROLE OF IMPLEMENTATION SCIENCE IN BEHAVIORAL INTERVENTION RESEARCHWHY IS PUTTING EVIDENCE INTO PRACTICE SO DIFFICULT?WHAT IS IMPLEMENTATION SCIENCE?FRAMEWORKS IN IMPLEMENTATION SCIENCENormalization Process TheoryTHE BLACK BOX OF IMPLEMENTATIONCONCLUSIONREFERENCESLESSONS LEARNED FROM IMPLEMENTING PROVEN INTERVENTIONS INTO REAL-WORLD CONTEXTSTHE CHALLENGE OF CONTEXTContextual FitCase ExamplesCaveats in Attending to Context Early OnHow Much Evidence Is Sufficient?INTERVENTIONIST CHARACTERISTICSVALUE ALIGNMENTCONCLUSIONREFERENCESDISSEMINATING PROVEN BEHAVIORAL INTERVENTIONS: WHAT DOES IT TAKE?WHY IS DISSEMINATION DIFFICULT?DETERMINING AN INTERVENTION'S DISSEMINATION POTENTIALAssessing Intervention CharacteristicsUnderstanding ContextEvaluating Fit Between the Intervention and a Practice SettingDetermining Leadership CapacityAccess to Communications ChannelsBUILDING A ROBUST DISSEMINATION PLANKnowledge of the Environment and Its StakeholdersValue Propositions: Describing What Is in It for “Them”Creating an Infrastructure and Plan for DisseminationWHAT DOES DISSEMINATION COST?CONCLUSIONREFERENCESV PROFESSIONAL CONSIDERATIONS AND REFLECTIONSBECOMING AND BEING A BEHAVIORAL INTERVENTION RESEARCHER: WHAT DOES IT TAKE?STAFF-RELATED CONSIDERATIONSHiring ProcessSpace ConsiderationsRoles and ResponsibilitiesTraining StaffONGOING SUPPORT AND OVERSIGHTCOLLABORATING AND LEADING TEAMSCAREER-RELATED CONSIDERATIONSCONCLUSIONREFERENCESGRANT WRITING CONSIDERATIONS FOR ADVANCING BEHAVIORAL INTERVENTIONSGENERAL GRANT WRITING TIPSWhat Is a Grant Proposal?Understanding Agency PrioritiesPreparing a Grant ApplicationFUNDING MECHANISMS ALONG THE ELONGATED PIPELINEGRANT WRITING CHALLENGES UNIQUE TO INTERVENTION RESEARCHNaming and Framing the Phase of Intervention DevelopmentAims Specific to Each PhaseImportance of Pilot DataResearch Methods SectionDescribing the InterventionPage LimitationsProof of FeasibilityHuman Subject ConsiderationsAppendicesBudgetary ConsiderationsCONCLUSIONREFERENCESWHAT TO PUBLISH AND WHEN: BEING PRODUCTIVE WHILE AWAITING MAIN OUTCOMES AND OTHER CONSIDERATIONSWHAT TO PUBLISH WHEN WAITING FOR MAIN OUTCOMESProtocol ManuscriptsSystematic Reviews or Meta-Analyses ManuscriptsDescribing Innovative Models or PartnershipsDescribing Novel Recruitment, Enrollment, or Screening ProcessesBaseline Data CollectionStructure of EvaluationsDescribing Behavioral InterventionsWHERE TO PUBLISHDISSEMINATING RESULTS AFTER PUBLICATIONCONCLUSIONREFERENCESSYNTHESIS AND FUTURE DIRECTIONS
 
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