Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06262958
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007316', 'term': 'Insemination, Artificial, Heterologous'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D007315', 'term': 'Insemination, Artificial'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007314', 'term': 'Insemination'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased consumption of alcohol, tobacco or substances', 'timeFrame': '6 months', 'description': 'Decreased scores in ASSIST questionnaire'}], 'secondaryOutcomes': [{'measure': 'BDI scores', 'timeFrame': '6 months', 'description': 'Decreased scores in BDI questionnaire'}, {'measure': 'GAD scores', 'timeFrame': '6 months', 'description': 'Decreased scores in GAD questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol', 'substance', 'abuse', 'mini-intervention', 'adolescent'], 'conditions': ['Alcoholism', 'Substance Abuse', 'Alcohol Dependence', 'Alcohol-Related Disorders', 'Substance Use Disorders', 'Adolescent Behavior', 'Adolescent Problem Behavior']}, 'descriptionModule': {'briefSummary': 'ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it', 'detailedDescription': 'All 14-20-year-old patients admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during 2017-2028 are requested to participate. At admission (baseline), the patients are interviewed by the research nurse and asked to fill out questionnaires. The interview includes a semi-structured diagnostic interview (SCID). The participants are interviewed again in six months (follow-up), and the interview is identical to the one conducted in the admission phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during the years 2016-2019\n\nExclusion Criteria: Unable to understand the questionnaires'}, 'identificationModule': {'nctId': 'NCT06262958', 'acronym': 'REAL-SMART', 'briefTitle': 'Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'REAL-SMART: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence, REAL/Systemic Metabolic Alterations Related to Different Psychiatric Disease Categories in Adolescent', 'orgStudyIdInfo': {'id': 'KUH5703459'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Clients are receiving normal adolescent psychiatric care, mostly psychotherapy, medications, or both.', 'interventionNames': ['Other: Treatment as usual']}, {'type': 'EXPERIMENTAL', 'label': 'e-form of ASSIST alcohol and substance use mini-intervention', 'description': 'Clients are receiving normal adolescent psychiatric care, mostly psychotherapy, medications, or both. In addition to that, they will receive a mini-intervention for substance and alcohol use.', 'interventionNames': ['Behavioral: ASSIST', 'Other: Treatment as usual']}], 'interventions': [{'name': 'ASSIST', 'type': 'BEHAVIORAL', 'description': 'Adolescent psychiatric outpatient will be offered an e-form of ASSIST alcohol and substance use mini-intervention. Results will be compared to those who received TAU.', 'armGroupLabels': ['e-form of ASSIST alcohol and substance use mini-intervention']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Psychotherapy and/or psychotropic drug treatment', 'armGroupLabels': ['Treatment as usual', 'e-form of ASSIST alcohol and substance use mini-intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70110', 'city': 'Kuopio', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Sanna Voutilainen, Res. nurse', 'role': 'CONTACT', 'email': 'sanna.voutilainen@kuh.fi', 'phone': '+358447175351'}], 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'centralContacts': [{'name': 'Tommi T Tolmunen, Docent', 'role': 'CONTACT', 'email': 'tommi.tolmunen@kuh.fi', 'phone': '+358447172994'}], 'overallOfficials': [{'name': 'Tommi T Tolmunen, Docent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}