Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01167556
Status:
UNKNOWN
Last Update Posted:
2010-07-22
First Post:
2010-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Family Motivational Intervention in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-21', 'studyFirstSubmitDate': '2010-07-20', 'studyFirstSubmitQcDate': '2010-07-21', 'lastUpdatePostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cannabis use in patients with a diagnosis of recent-onset schizophrenia', 'timeFrame': 'Baseline (before the start of the intervention)'}, {'measure': 'Cannabis use in patients with a diagnosis of recent-onset schizophrenia', 'timeFrame': '10-month follow-up (3 months after the intervention has ended)'}, {'measure': 'Cannabis use in patients with a diagnosis of recent-onset schizophrenia', 'timeFrame': '22-month follow-up (15 months after the intervention has ended)'}], 'secondaryOutcomes': [{'measure': 'Medication adherence in patients with a diagnosis of recent-onset schizophrenia', 'timeFrame': 'Baseline (before the start of the intervention)'}, {'measure': 'Medication adherence in patients with a diagnosis of recent-onset schizophrenia', 'timeFrame': '10-month follow-up (3 months after the intervention has ended)'}, {'measure': 'Medication adherence in patients with a diagnosis of recent-onset schizophrenia', 'timeFrame': '22-month follow-up (15 months after the intervention has ended)'}, {'measure': 'Quality of life in patients with recent-onset schizophrenia', 'timeFrame': 'Baseline (before the start of the intervention)'}, {'measure': 'Quality of life in patients with recent-onset schizophrenia', 'timeFrame': '10-month follow-up (3 months after the intervention has ended)'}, {'measure': 'Quality of life in patients with recent-onset schizophrenia', 'timeFrame': '22-month follow-up (15 months after the intervention has ended)'}, {'measure': 'Stress in parents due to caring for a child with recent-onset schizophrenia', 'timeFrame': 'Baseline (before the start of the intervention)'}, {'measure': 'Stress in parents due to caring for a child with recent-onset schizophrenia', 'timeFrame': '10-month follow-up (3 months after the intervention has ended)'}, {'measure': 'Stress in parents due to caring for a child with recent-onset schizophrenia', 'timeFrame': '22-month follow-up (15 months after the intervention has ended)'}, {'measure': 'Expressed emotion in parents of patients with recent-onset schizophrenia', 'timeFrame': 'Baseline (before the start of the intervention)'}, {'measure': 'Expressed emotion in parents of patients with recent-onset schizophrenia', 'timeFrame': '10-month follow-up (3 months after the intervention has ended)'}, {'measure': 'Expressed emotion in parents of patients with recent-onset schizophrenia', 'timeFrame': '22-month follow-up (15 months after the intervention has ended)'}]}, 'conditionsModule': {'keywords': ['Family intervention', 'Recent-onset schizophrenia', 'Motivational Interviewing', 'Cannabis use'], 'conditions': ['Cannabis', 'Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '19917142', 'type': 'BACKGROUND', 'citation': 'Dekker N, Smeerdijk AM, Wiers RW, Duits JH, van Gelder G, Houben K, Schippers G, Linszen DH, de Haan L. Implicit and explicit affective associations towards cannabis use in patients with recent-onset schizophrenia and healthy controls. Psychol Med. 2010 Aug;40(8):1325-36. doi: 10.1017/S0033291709991814. Epub 2009 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'Cannabis use by people with schizophrenia is associated with family distress and poor clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to help parents to motivate their child with a diagnoses of recent-onset schizophrenia to reduce cannabis use.\n\nIn a single-blind randomised clinical trail with 75 patients with the diagnosis of schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will be conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that FMI will be more effective than routine care in reducing (a) cannabis use in patients and (b) distress and sense of burden in parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of schizophrenia or psychotic-related disorder\n* Onset of schizophrenia or related disorder within pervious the 10 years\n* Cannabis use at least 2 days per week in the 3 months prior to the assessment\n* Antipsychotic medication in prescribed or indicated\n* At least 10 hours of contact with the parents each week in the last month\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01167556', 'acronym': 'FMI', 'briefTitle': 'Family Motivational Intervention in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'Grant 100003014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family Motivational Intervention', 'description': 'An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.', 'interventionNames': ['Behavioral: Family Motivational Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine care for parents', 'description': 'Routine care for parents consisting of 2 sessions psycho-education and individual support', 'interventionNames': ['Behavioral: Family Motivational Intervention']}], 'interventions': [{'name': 'Family Motivational Intervention', 'type': 'BEHAVIORAL', 'description': 'A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.', 'armGroupLabels': ['Family Motivational Intervention', 'Routine care for parents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066 DP', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Gerard Schippers, Prof. dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'Don Linszen, Prof.dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'Lieuwe de Haan, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Don Linszen/ MD, PhD', 'oldOrganization': 'AMC'}}}}