Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT01595568
Status:
UNKNOWN
Last Update Posted:
2012-07-19
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population
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': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D019955', 'term': 'Conduct Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-08', 'lastUpdatePostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Binge drinking frequency', 'timeFrame': 'Baseline - 4months'}, {'measure': 'Change in Drinking frequency', 'timeFrame': 'Baseline - 4 months'}, {'measure': 'Change in Drinking quantity', 'timeFrame': 'Baseline - 4 months'}, {'measure': 'Change in Drinking problems', 'timeFrame': 'Baseline - 4 months'}], 'secondaryOutcomes': [{'measure': 'Change in Emotional and behavioural problems', 'timeFrame': 'Baseline - 4 months', 'description': 'Psychiatric symptoms (depression, panic anxiety, antisocial behaviours), coping skills, motives for drinking, assessed using the Strengths and Difficulties Questionnaire, the Drinking Motives Questionnaire and the Brief Symptom Inventory.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adolescents', 'Dual Diagnosis', 'Mental Disorders', 'Substance Use Problems', 'Prevention'], 'conditions': ['Alcohol Abuse', 'Drug Abuse', 'Mood Disorder', 'Anxiety Disorder', 'Conduct Disorder']}, 'descriptionModule': {'briefSummary': "In adolescents, mental health problems are frequently associated with substance misuse, even considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to complicate the patient's treatment and prognosis by increasing, among others, substance use problems, reckless behaviours, relationships and school problems and suicidal thoughts. It is therefore critical to invest time and effort into developing an efficient approach to prevent and reduce substance use problems and offer these children a more global and optimal treatment.\n\nA brief personality-targeted intervention was developed with students of Canadian and English high schools based on four personality factors known to be implicated in the vulnerability to adolescent alcohol misuse (Impulsivity, Anxiety Sensitivity, Negative Thinking and Sensation Seeking) (Conrod et al., 2006,2008, O'Leary-Barrett 2010).\n\nBy helping the adolescents to develop better adaptive behaviours, this cognitive-behavioural intervention proved to reduce binge drinking, quantity and frequency of use and substance use problems (Conrod et al., 2006,2011).\n\nThe purpose of this study is to assess the impact of this intervention if combined to a regular treatment in a youth psychiatric population.\n\n60 patients aged 14-17 years of a Child and Adolescent psychiatric department will be screened for personality risk with self-report assessments including the Substance Use Risk Profile Scale. Participants will be randomly assigned to a personality matched cognitive-behavioural intervention or a no-intervention control.\n\nThe main outcome measures of this study are alcohol and illicit drug outcomes. Secondary measures include mental health symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Motive for psychiatric consultation\n* Able to provide consent from parent/guardian for participation in the study'}, 'identificationModule': {'nctId': 'NCT01595568', 'briefTitle': 'Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'orgStudyIdInfo': {'id': 'CER CHU Ste-Justine 3435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Learning to cope with your impulsivity', 'description': 'Cognitive-behavioural intervention targeting impulsive personality', 'interventionNames': ['Behavioral: Personality-targeted interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Learning to cope with your sensation seeking', 'description': 'Cognitive behavioural intervention designed to help sensation seeking youth manage their need for stimulation and excitement.', 'interventionNames': ['Behavioral: Personality-targeted interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Learning to cope with your anxiety sensitivity', 'description': 'Cognitive behavioural intervention teaching anxiety sensitive youth to manager their sensitivity to threat and anxiety.', 'interventionNames': ['Behavioral: Personality-targeted interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Learning to manage your negative thinking', 'description': 'Cognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth', 'interventionNames': ['Behavioral: Personality-targeted interventions']}], 'interventions': [{'name': 'Personality-targeted interventions', 'type': 'BEHAVIORAL', 'otherNames': ['Preventure', 'Adventure'], 'description': 'Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator', 'armGroupLabels': ['Learning to cope with your impulsivity']}, {'name': 'Personality-targeted interventions', 'type': 'BEHAVIORAL', 'otherNames': ['Preventure', 'Adventure'], 'description': 'Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator', 'armGroupLabels': ['Learning to cope with your sensation seeking']}, {'name': 'Personality-targeted interventions', 'type': 'BEHAVIORAL', 'otherNames': ['Preventure', 'Adventure'], 'description': 'Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator', 'armGroupLabels': ['Learning to cope with your anxiety sensitivity']}, {'name': 'Personality-targeted interventions', 'type': 'BEHAVIORAL', 'otherNames': ['Preventure', 'Adventure'], 'description': 'Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator', 'armGroupLabels': ['Learning to manage your negative thinking']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'email': 'eveline.perrier-menard@umontreal.ca'}], 'facility': 'CHU Ste-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Eveline Perrier-Ménard, MD', 'role': 'CONTACT', 'email': 'eveline.perrier-menard@umontreal.ca', 'phone': '514-345-4931', 'phoneExt': '4050'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Master student', 'investigatorFullName': 'Eveline Perrier-Ménard', 'investigatorAffiliation': "St. Justine's Hospital"}}}}