2021
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial
Tong G, Seal KH, Becker WC, Li F, Dziura JD, Peduzzi PN, Esserman DA. Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial. Clinical Trials 2021, 19: 3-13. PMID: 34693748, PMCID: PMC8847260, DOI: 10.1177/17407745211051288.Peer-Reviewed Original ResearchConceptsGroup treatment trialsIntraclass correlation coefficientTreatment trialsTreatment sessionsHealth optionsEducation trialThree-armWhole health teamFuture trial designNumber of cliniciansGroup treatment designTrue intraclass correlation coefficientsGroup treatment sessionsTreatment armsClinical trialsClinician levelMultiple cliniciansBACKGROUND/Health teamsOutcome dataTreatment groupsTrial designGroup educationClinical scenariosDifferent clinicians
2008
Trial Design Challenges When Combining Medication and Parent Training in Children with Pervasive Developmental Disorders
Scahill L, Aman MG, McDougle CJ, Arnold LE, McCracken JT, Handen B, Johnson C, Dziura J, Butter E, Sukhodolsky D, Swiezy N, Mulick J, Stigler K, Bearss K, Ritz L, Wagner A, Vitiello B. Trial Design Challenges When Combining Medication and Parent Training in Children with Pervasive Developmental Disorders. Journal Of Autism And Developmental Disorders 2008, 39: 720-729. PMID: 19096921, PMCID: PMC4807607, DOI: 10.1007/s10803-008-0675-2.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAggressionBehavior TherapyChildChild Development Disorders, PervasiveCombined Modality TherapyDopamine AntagonistsFemaleHumansMaleOutpatientsParent-Child RelationsParentsPatient CompliancePersonality AssessmentPsychiatric Status Rating ScalesRisperidoneSelf-Injurious BehaviorTreatment OutcomeConceptsParent trainingAdaptive functioningPervasive developmental disorderMeasures of noncomplianceBehavioral interventionsSymptom reductionDevelopmental disordersTraining targetClinical treatment targetsTrial design challengesTreatment targetsFunctioningTrainingFunctional improvementLow doseTreatment groupsMedicationsClinical practiceTantrumsAggressionBeneficial effectsIrritabilityChildrenNoncomplianceDisorders