Nctid:
NCT00000387
Payload:
{"FullStudy"=>{"Rank"=>474922, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 06, 2023", "SubmissionTracking"=>{"SubmissionInfoList"=>{"SubmissionInfo"=>[{"SubmissionResetDate"=>"December 23, 2015", "SubmissionReleaseDate"=>"November 19, 2015"}, {"SubmissionResetDate"=>"July 6, 2018", "SubmissionReleaseDate"=>"June 7, 2018"}]}}}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000012559", "ConditionMeshTerm"=>"Schizophrenia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000019967", "ConditionAncestorTerm"=>"Schizophrenia Spectrum and Other Psychotic Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M15066", "ConditionBrowseLeafName"=>"Schizophrenia", "ConditionBrowseLeafAsFound"=>"Schizophrenia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21528", "ConditionBrowseLeafName"=>"Schizophrenia Spectrum and Other Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"40"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"April 1998"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2007", "CompletionDateStruct"=>{"CompletionDate"=>"January 2005", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 26, 2007", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 28, 2007", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"January 2005", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Increase in CAFAS level of functioning for all adolescents.", "PrimaryOutcomeTimeFrame"=>"Over the course of 14 months"}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"Increase in family functioning for families in the treatment group according to the designated family respondent.", "SecondaryOutcomeTimeFrame"=>"Over the course of 14 months"}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Adolescence", "Family", "Female", "Human", "Male", "Schizophrenia", "Self Care", "Community Health Services"]}, "ConditionList"=>{"Condition"=>["Schizophrenia"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The study will test the intervention's effectiveness in improving the adolescents' behavior, thinking, mood, and use of substances such as drugs and alcohol. The study also will look at the effects of the patient on the family.\n\nThe intervention involves training in recognizing symptoms of schizophrenia and in stress management, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents.\n\nThe Self-Management Therapy intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. The effects of the intervention on the patient and his/her family are assessed prior to treatment, after 6 sessions, after 12 sessions, and in a follow-up visit 6 months after completion of sessions.\n\nA child may be eligible for this study if he/she:\n\nIs 15 to 19 years old and has been diagnosed with schizophrenia.", "DetailedDescription"=>"To test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The primary aim is to test its effectiveness in improving the adolescents' level of functioning in role performance, thinking/cognitive processing, behavior towards others, mood, and use of substances. The second aim is to assess the impact of the intervention on family functioning. The third aim is to describe the relationships among the process variables of the intervention.\n\nNakagawa-Kogan's self-management nursing model, Kanfer's self-regulation theory, and Liberman's theory of stress and vulnerability provide the theoretical basis for the self-management intervention developed specifically for a population with deficits in cognitive processing. The intervention involves training in symptom awareness, stress management skills, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents.\n\nThe adolescent's level of functioning is assessed using the Child and Adolescent Functional Assessment Scale, the Birchwood Early Signs & Symptoms Scale for schizophrenia, and the DISA. Family Functioning is assessed by computing a Composite Family Functioning Index using weighted scores from the FACES II, Family Apgar, Family Empowerment, and Family Social Support scales. One parent is designated by the family to be the family respondent on the scales. The adolescents are referred to the study by mental health professionals. The intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. Data are collected at 4 points in time: at baseline, after 6 intensive sessions, after 6 monthly reinforcement sessions, and 6 months post-intervention. ANCOVA is used to test the study hypotheses. Multivariate relationships are examined among the process variables of the intervention."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"19 years", "MinimumAge"=>"15 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\n-\n\nPatients must have:\n\nSchizophrenia as diagnosed according to DSM-IV criteria when screened by a mental health professional using the K-SADS and the DISA."}, "IdentificationModule"=>{"NCTId"=>"NCT00000387", "Acronym"=>"FamCent", "BriefTitle"=>"Self-Management Therapy for Youth With Schizophrenia", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Mental Health (NIMH)"}, "OfficialTitle"=>"Self-Management Therapy for Youth With Schizophrenia", "OrgStudyIdInfo"=>{"OrgStudyId"=>"R01MH056580", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/R01MH056580", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"DSIR CT-S"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"A,1,III", "ArmGroupDescription"=>"Behavioral intervention - Self management therapy", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Behavioral: Self-management therapy"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"A,2,III", "ArmGroupDescription"=>"Regular treatment", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Behavioral: Self-management therapy"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Self-management therapy", "InterventionType"=>"Behavioral", "InterventionDescription"=>"Behavioral", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["A,1,III", "A,2,III"]}}, {"InterventionName"=>"Self-management therapy", "InterventionType"=>"Behavioral", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["A,1,III", "A,2,III"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"98195", "LocationCity"=>"Seattle", "LocationState"=>"Washington", "LocationCountry"=>"United States", "LocationFacility"=>"University of Washington"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Karen G. Schepp, PhD", "OverallOfficialRole"=>"Principal Investigator"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Mental Health (NIMH)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyOldNameTitle"=>"Karen G. Schepp", "ResponsiblePartyOldOrganization"=>"NIMH"}}}, "AnnotationSection"=>{"AnnotationModule"=>{"UnpostedAnnotation"=>{"UnpostedEventList"=>{"UnpostedEvent"=>[{"UnpostedEventDate"=>"November 19, 2015", "UnpostedEventType"=>"Release"}, {"UnpostedEventDate"=>"December 23, 2015", "UnpostedEventType"=>"Reset"}, {"UnpostedEventDate"=>"June 7, 2018", "UnpostedEventType"=>"Release"}, {"UnpostedEventDate"=>"July 6, 2018", "UnpostedEventType"=>"Reset"}]}, "UnpostedResponsibleParty"=>"Karen Schepp, Professor, Psychosocial & Community Health, University of Washington"}}}}}}
