Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-21 @ 12:13 AM
Study NCT ID:
NCT00043693
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2002-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Intervention for Mental Illness and Substance Abuse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011934', 'term': 'mica'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2002-08-12', 'studyFirstSubmitQcDate': '2002-08-14', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol use scale-revised', 'timeFrame': 'Measured at baseline, during treatment, and post-treatment'}, {'measure': 'Drug use scale-revised', 'timeFrame': 'Measured at baseline, during treatment, and post-treatment'}, {'measure': 'Substance abuse treatment scale', 'timeFrame': 'Measured at baseline, during treatment, and post-treatment'}, {'measure': 'Timeline followback calandar', 'timeFrame': 'Measured at baseline, during treatment, and post-treatment'}]}, 'conditionsModule': {'keywords': ['Psychotic Disorders', 'Schizoaffective Disorder', 'Substance Abuse'], 'conditions': ['Schizophrenia', 'Bipolar Disorder', 'Substance-related Disorders']}, 'referencesModule': {'references': [{'pmid': '12046678', 'type': 'BACKGROUND', 'citation': 'Mueser KT, Fox L. A family intervention program for dual disorders. Community Ment Health J. 2002 Jun;38(3):253-70. doi: 10.1023/a:1015271908765.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate a family intervention program for individuals with bipolar disorder, schizophrenia, or schizoaffective disorder and co-occurring substance use disorders.', 'detailedDescription': 'Substance use disorder (SUD) in persons with severe mental illness may worsen the course of psychiatric illness. The loss of family support for individuals with mental illness is a major contributing factor to housing instability, homelessness, and other problems. Despite progress toward integrating mental health and substance abuse services, interventions that improve the course of mental illness while helping the families of the mentally ill are not currently available. Enhancing skills for coping with mental illness may be an effective strategy for treating SUD, decreasing caregiver burden, and improving the long-term outcomes for people with mental illness.\n\nPatients and their families are randomly assigned to either the Family Intervention for Dual Diagnosis (FIDD) program or family psychoeducation. The FIDD program lasts for up to 3 years and includes both single and multiple-family group formats. The family psychoeducation program consists of 6 weekly sessions. Routine assessments are conducted on all patients, and relatives are evaluated on a wide range of outcomes, including substance abuse, hospitalizations, psychiatric symptoms, legal problems, aggression, housing and homelessness, family burden, social support, and quality of life. To determine the effectiveness of the FIDD program, knowledge of mental illness and problem-solving skills are assessed in the families following treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have schizophrenia, schizoaffective disorder, or bipolar disorder\n* Have a current substance use disorder (within the past 6 months)\n* Are willing to have at least 4 hours of contact per week with family members or significant others\n* Plan to remain in the community\n* Have family members or significant others who consent to participate in the study and plan to remain in the community'}, 'identificationModule': {'nctId': 'NCT00043693', 'briefTitle': 'Family Intervention for Mental Illness and Substance Abuse', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Family Intervention for SMI and Substance Use Disorder', 'orgStudyIdInfo': {'id': 'R01MH062629', 'link': 'https://reporter.nih.gov/quickSearch/R01MH062629', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH062629', 'link': 'https://reporter.nih.gov/quickSearch/R01MH062629', 'type': 'NIH'}, {'id': 'DSIR SE-CE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will undergo the Family Intervention for Dual Diagnosis (FIDD) program.', 'interventionNames': ['Behavioral: Family Intervention for Dual Diagnosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will be placed in a family psychoeducation program.', 'interventionNames': ['Behavioral: Family psychoeducation program']}], 'interventions': [{'name': 'Family Intervention for Dual Diagnosis', 'type': 'BEHAVIORAL', 'description': 'The family intervention for dual diagnosis program lasts for up to 3 years and includes both single and multiple-family group formats.', 'armGroupLabels': ['1']}, {'name': 'Family psychoeducation program', 'type': 'BEHAVIORAL', 'description': 'The family psychoeducation program consists of 6 weekly sessions.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90670-3691', 'city': 'Santa Fe Springs', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinics El Camino', 'geoPoint': {'lat': 33.94724, 'lon': -118.08535}}, {'zip': '02150', 'city': 'Chelsea', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'North Suffolk Mental Health Association', 'geoPoint': {'lat': 42.39176, 'lon': -71.03283}}], 'overallOfficials': [{'name': 'Kim T. Mueser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}, {'name': 'Shirley Glynn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}