{
  "FullStudy":{
    "Rank":217664,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518452",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011/532"
          },
          "Organization":{
            "OrgFullName":"Norwegian University of Science and Technology",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age",
          "OfficialTitle":"Computerized Working Memory Training Evaluated With Clinical Assessments and Quantitative EEG in Very-low-birth-weight (VLBW) Children at Preschool Age"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 13, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 14, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Norwegian University of Science and Technology",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No",
          "IsFDARegulatedDrug":"No",
          "IsFDARegulatedDevice":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The main aim of this prospective interventional study is to compare quantitative EEG findings and cognitive and neuropsychological test results before and after training with the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6 years. The investigators hypothesize that the children in the study may respond positively to the computerized training and improve working memory, but probably to different degrees depending on the underlying neurological condition. The investigators also hypothesize that training may benefit additional executive functions.",
          "DetailedDescription":"Children born preterm are at increased risk of neurological disabilities due to perinatal brain damage. During the last ten years an increasing number of especially extremely low birth weight (ELBW: BW ≤ 1000g) children has survived, and one might wonder whether this has lead to increased amount of brain pathology and impairments among survivors. Major impairments including cerebral palsy, mental retardation and impaired vision and hearing are most common in children born extremely preterm (gestational age below 28 weeks). In addition to this, a large part of survivors after preterm birth will experience motor problems, cognitive dysfunctions, psychiatric and behavioural problems of varying severity.\n\nIn our previous research we have found significant deficits in working memory in very preterm born children, and this seems to have a strong influence on cognitive functioning. During the last years, several studies have shown that working memory skills can be trained, and training working memory to improve cognition and executive functions is regarded as one of the major steps forward in neuroscience in recent years.\n\nThe working memory training program version for preschoolers, Cogmed JM, has recently been launched. Healthy preschoolers trained on working memory improved significantly on trained tasks but also on non-trained tests of spatial and verbal working memory, as well as transfer effects on attention. The preschool version of the program has not yet been administered to preterm born or other neurologic high risk children in this age group.\n\nThe main aim of this prospective interventional study is to compare quantitative EEG findings and cognitive and neuropsychological test results before and after training with the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6 years. We hypothesise that the children in the study may respond positively to the computerized training and improve working memory, but probably to different degrees depending on the underlying neurological condition. We also hypothesise that training may benefit additional executive functions.\n\nThe children in the study will be divided into two subgroups (15/15 children). Subgroup A will start training, while subgroup B waits during this first training period. Subgroup B will therefore act as a control group. After 8 weeks subgroup B will then start training. This is in agreement with the so-called Stepped Wedge design (Brown and Lilford 2006)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Infant, Very Low Birth Weight"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "working memory training, computerized",
              "clinical assessment",
              "quantitative EEG",
              "child, preschool"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"20",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"working memory training",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Cogmed JM working memory training",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Cogmed JM working memory training"
                  ]
                }
              },{
                "ArmGroupLabel":"delayed working memory training",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Cogmed JM working memory training after 8 weeks waiting",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Cogmed JM working memory training after waiting"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Cogmed JM working memory training",
                "InterventionDescription":"daily training for 5 weeks on a computerized program for training working memory; a total of 25 training sessions. Program: Cogmed JM - preschool version of program: 15-20 minutes training per day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "working memory training"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Cogmed JM working memory training after waiting",
                "InterventionDescription":"Waiting after baseline testing for 8 weeks. Daily training on a computerized program for training working memory for 5 weeks. 25 training sessions in total. Program: Cogmed JM - preschool version of program: 15-20 minutes training per day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "delayed working memory training"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"working memory capacity",
                "PrimaryOutcomeDescription":"Automated Working Memory Assessment (AWMA)(visual working memory); digit span (from WISC-IV); Repetition of scentences (from NEPSY battery); Remembering and oral story (from NEPSY battery); Remembering faces (from NEPSY battery)",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"behavioral function",
                "SecondaryOutcomeDescription":"Vineland adaptive behaviour scales (survey form)",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"executive function",
                "SecondaryOutcomeDescription":"The ADHD Rating Scale-IV (parents report)",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"anxiety as judged by parents",
                "SecondaryOutcomeDescription":"The Screen for Child Anxiety Related Emotional Disorders (SCARED- parent report); Preschool Anxiety Scale (parent report)",
                "SecondaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nVLBW (birth weight ≤ 1500 grams)\npreschool child\nborn at St. Olav's University Hospital in Trondheim in 2005 and 2006\n\nExclusion Criteria:\n\nbirth weight >1500 grams\ndiagnosed genetic syndromes\nsevere cerebral palsy with totally impaired bilateral hand function (GMFCS - gross motor function classification scale level V)\nblindness",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"4 Years",
          "MaximumAge":"6 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jon Skranes, PhD prof",
                "OverallOfficialAffiliation":"Norwegian University of Science and Technology",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"St Olavs Hospital",
                "LocationCity":"Trondheim",
                "LocationCountry":"Norway"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"23400616",
                "ReferenceType":"result",
                "ReferenceCitation":"Grunewaldt KH, Løhaugen GC, Austeng D, Brubakk AM, Skranes J. Working memory training improves cognitive function in VLBW preschoolers. Pediatrics. 2013 Mar;131(3):e747-54. doi: 10.1542/peds.2012-1965. Epub 2013 Feb 11."
              },{
                "ReferencePMID":"26140426",
                "ReferenceType":"result",
                "ReferenceCitation":"Grunewaldt KH, Skranes J, Brubakk AM, Lähaugen GC. Computerized working memory training has positive long-term effect in very low birthweight preschool children. Dev Med Child Neurol. 2016 Feb;58(2):195-201. doi: 10.1111/dmcn.12841. Epub 2015 Jul 3."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001835",
                "ConditionMeshTerm":"Body Weight"
              },{
                "ConditionMeshId":"D000001724",
                "ConditionMeshTerm":"Birth Weight"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafAsFound":"Weight",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3588",
                "ConditionBrowseLeafName":"Birth Weight",
                "ConditionBrowseLeafAsFound":"Birth Weight",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}