Nctid:
NCT06612333
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000035583", "term"=>"Rare Diseases"}, {"id"=>"D000065886", "term"=>"Neurodevelopmental Disorders"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M30644", "name"=>"Neurodevelopmental Disorders", "asFound"=>"Neurodevelopmental Disorders", "relevance"=>"HIGH"}, {"id"=>"M24518", "name"=>"Rare Diseases", "asFound"=>"Rare disease", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>80}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-05-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-08-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-04-26", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-08-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases participating in the social skills program", "timeFrame"=>"2023 - 2025", "description"=>"Quality of Play Questionnaire-Adolescent (QPQ-A) (QSQP in French)"}, {"measure"=>"Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases", "timeFrame"=>"2023 - 2025", "description"=>"Friendship Quality Scale (FQS)"}, {"measure"=>"Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases", "timeFrame"=>"2023 - 2025", "description"=>"Social Anxiety Scale for Adolescent (SAS-A)"}, {"measure"=>"Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases", "timeFrame"=>"2023 - 2025", "description"=>"Loneliness and Social Dissatisfaction Scale (L\\&SD)"}, {"measure"=>"Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases", "timeFrame"=>"2023 - 2025", "description"=>"Test of Adolescent Social Skills Knowledge (TASSK)"}, {"measure"=>"Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases", "timeFrame"=>"2023 - 2025", "description"=>"Self-Assessment of Conversational Skills (AHC)"}, {"measure"=>"Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases", "timeFrame"=>"2023 - 2025", "description"=>"Beck Youth Inventories (BYI)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Neurodevelopmental Disorders", "Rare Diseases"]}, "descriptionModule"=>{"briefSummary"=>"Adolescents and young adults with rare neurodevelopmental disorders are at risk of developing psychiatric pathologies during the transition to adulthood. Loneliness and lack of social relationships can lead to anxiety and depression in adolescents and young adults with rare neurodevelopmental disorders. Anxiety and depression are major risk factors for the transition to psychiatric symptoms in adulthood. The improvement of social skills and the positive evolution of social relationships in adolescents and young adults with rare neurodevelopmental disorders can lead to a reduction in the risk factors for anxiety and depression. It therefore seems essential to evaluate the evolution of social skills in this population of young adults under the care of the social skills program, PEERS, in France to assess the overall benefit of the program, particularly in this population of young people with rare neurodevelopmental disorders."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"30 years", "minimumAge"=>"12 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"The study will focus on data from 40 patients with rare neurodevelopmental disorders and their 40 relatives/friends.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion criteria:\n\n* Aged between 12 and 30 years, included at the start of the social skills program.\n* Patients with rare neurodevelopmental diseases\n* Patients benefiting from the social skills program\n* Appropriate level of verbal elaboration\n* Patient with a family member or a friend also participating in the social skills program\n\nNon-inclusion criteria :\n\n* Opposition of the patient or, if a minor, of his/her parents to participation in the study\n* Patient not psychiatrically stabilized: acute symptoms of anxiety, depression, psychotic disorders.\n* Severe intellectual disability"}, "identificationModule"=>{"nctId"=>"NCT06612333", "acronym"=>"PEERS-MRND", "briefTitle"=>"Evaluation of the French Version of the PEERS Social Skills Training Program for Adolescents With Rare Neurodevelopmental Disorders", "organization"=>{"class"=>"OTHER", "fullName"=>"Imagine Institute"}, "officialTitle"=>"Evaluation of the French Version of the PEERS Social Skills Training Program for Adolescents With Rare Neurodevelopmental Disorders / PEERS-MRND", "orgStudyIdInfo"=>{"id"=>"HJ-23-PEERS-MRND"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patient", "description"=>"Inclusion criteria:\n\n* Aged between 12 and 30 years, included at the start of the social skills program.\n* Patients with rare neurodevelopmental diseases\n* Patients benefiting from the social skills program\n* Appropriate level of verbal elaboration\n* Patient with a family member or a friend also participating in the social skills program\n\nNon-inclusion criteria :\n\n* Opposition of the patient or, if a minor, of his/her parents to participation in the study\n* Patient not psychiatrically stabilized: acute symptoms of anxiety, depression, psychotic disorders.\n* Severe intellectual disability"}, {"label"=>"Family member or friend", "description"=>"Inclusion criteria:\n\n* be over 18 years\n* be a close relative or friend of a patient and share in his or her daily life\n* have taken or are taking the social skills program\n\nNon-inclusion criteria :\n\n- Opposition to participation in the study"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75015", "city"=>"Paris", "state"=>"Ile-de-France", "status"=>"RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Evandelia Valladier", "role"=>"CONTACT", "email"=>"evandelia.valladier@aphp.fr"}], "facility"=>"Necker - Enfants Malades Hospital", "geoPoint"=>{"lat"=>48.85341, "lon"=>2.3488}}], "centralContacts"=>[{"name"=>"Marlène Rio, Dr", "role"=>"CONTACT", "email"=>"marlene.rio@aphp.fr", "phone"=>"01 44 49 40 00"}, {"name"=>"Evandelia Valladier", "role"=>"CONTACT", "email"=>"evandelia.valladier@aphp.fr"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Imagine Institute", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
