{
  "FullStudy":{
    "Rank":218181,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511679",
          "OrgStudyIdInfo":{
            "OrgStudyId":"BANC RFA-AA-12-006"
          },
          "Organization":{
            "OrgFullName":"Boston Children’s Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Brain-imaging and Adolescent Neuroscience Consortium",
          "OfficialTitle":"Brain-imaging and Adolescent Neuroscience Consortium",
          "Acronym":"BANC"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2013",
          "OverallStatus":"Withdrawn",
          "WhyStopped":"The project was not funded.",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2017",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2017",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 2, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 3, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Boston Children’s Hospital",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Massachusetts General Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Mclean Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Massachusetts Institute of Technology",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a multi-site study of adolescents 12-21 years-of-age to evaluate the long and shorter-term effect of adolescent alcohol use on the developing brain.",
          "DetailedDescription":"The overall specific aims of this study are to: 1) assess the short and long-term consequences of alcohol exposure on brain, cognitive, and emotional/regulatory development during preadolescence and adolescence; 2) determine the effects of timing, dose, and duration of alcohol on brain and cognitive development; 3) assess recovery of neural and behavioral function to determine if the plasticity of the adolescent brain makes it more or less vulnerable to alcohol's acute and chronic effects; 4) understand how other key covariates (e.g., existing or emerging psychopathology, family history of alcoholism, demographics, pubertal development) factor into alcohol's effects on the brain; and 5) identify early neural, cognitive, and affective markers that may predict alcohol abuse and dependence during adolescence and/or adulthood."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Alcohol Abuse"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Alcohol abuse"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Saliva DNA samples for future analyses."
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Alcohol-naive adolescents",
                "ArmGroupDescription":"A general population longitudinal cohort of alcohol-naïve (or h/o minimal recent-onset drinking) adolescents in three specific age-groups: early (12-14 y/o), middle (15-17 y/o), and late (18-21 y/o)."
              },{
                "ArmGroupLabel":"Treatment sample",
                "ArmGroupDescription":"A sample of adolescents who have a >1 year history of heavy drinking but have agreed to stop drinking as part of their treatment plan"
              },{
                "ArmGroupLabel":"High risk sample",
                "ArmGroupDescription":"High-risk adolescents who have a family history of alcohol-use disorder and other risk factors (symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD), Conduct Disorder, or Mood Disorder)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nable to read and understand English\navailable for follow-up\nparental consent/adolescent assent for those 12-17 years\nconsent for those 18-21 years\n\nExclusion Criteria:\n\nWeight > 300 lbs\nbraces or unremovable embedded metal\nclaustrophobia or inability to lie still in MRI machine\ncurrent or past 12-mos pregnancy (females)\nrequires urgent medical/mental health care",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"12 Years",
          "MaximumAge":"21 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          },
          "StudyPopulation":"Male and female adolescents 12-21 years-of-age presenting for care at one of the participating medical clinics",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"John R Knight, MD",
                "OverallOfficialAffiliation":"Boston Children’s Hospital",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Gordon J Harris, PhD",
                "OverallOfficialAffiliation":"Massachusetts General Hospital",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Simon Warfield, PhD",
                "OverallOfficialAffiliation":"Boston Children’s Hospital",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Avram Holmes, PhD",
                "OverallOfficialAffiliation":"Harvard University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Scott Lukas, PhD",
                "OverallOfficialAffiliation":"Mclean Hospital",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Marisa Silveri, PhD",
                "OverallOfficialAffiliation":"Mclean Hospital",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Marlene Oscar Berman, PhD",
                "OverallOfficialAffiliation":"Boston University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"John Gabrieli, PhD",
                "OverallOfficialAffiliation":"Massachusetts Institute of Technology",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"McLean Hospital",
                "LocationCity":"Belmont",
                "LocationState":"Massachusetts",
                "LocationZip":"02478",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Massachusetts General Hospital",
                "LocationCity":"Boston",
                "LocationState":"Massachusetts",
                "LocationZip":"02114",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Boston University School of Medicine",
                "LocationCity":"Boston",
                "LocationState":"Massachusetts",
                "LocationZip":"02118",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Massachusetts Institute of Technology",
                "LocationCity":"Cambridge",
                "LocationState":"Massachusetts",
                "LocationZip":"02139",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Center for Adolescent Substance Abuse Research at Children's Hospital Boston",
                "SeeAlsoLinkURL":"http://www.ceasar.org"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000000437",
                "ConditionMeshTerm":"Alcoholism"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000019973",
                "ConditionAncestorTerm":"Alcohol-Related Disorders"
              },{
                "ConditionAncestorId":"D000019966",
                "ConditionAncestorTerm":"Substance-Related Disorders"
              },{
                "ConditionAncestorId":"D000064419",
                "ConditionAncestorTerm":"Chemically-Induced Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M2364",
                "ConditionBrowseLeafName":"Alcoholism",
                "ConditionBrowseLeafAsFound":"Alcohol Abuse",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20426",
                "ConditionBrowseLeafName":"Alcohol-Related Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20421",
                "ConditionBrowseLeafName":"Substance-Related Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M28889",
                "ConditionBrowseLeafName":"Chemically-Induced Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC25",
                "ConditionBrowseBranchName":"Substance Related Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}