Family Intervention for Mental Illness and Substance Abuse
Primary Purpose
Schizophrenia, Bipolar Disorder, Substance-related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Intervention for Dual Diagnosis
Family psychoeducation program
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Psychotic Disorders, Schizoaffective Disorder, Substance Abuse
Eligibility Criteria
Inclusion Criteria: Have schizophrenia, schizoaffective disorder, or bipolar disorder Have a current substance use disorder (within the past 6 months) Are willing to have at least 4 hours of contact per week with family members or significant others Plan to remain in the community Have family members or significant others who consent to participate in the study and plan to remain in the community
Sites / Locations
- Pacific Clinics El Camino
- North Suffolk Mental Health Association
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will undergo the Family Intervention for Dual Diagnosis (FIDD) program.
Participants will be placed in a family psychoeducation program.
Outcomes
Primary Outcome Measures
Alcohol use scale-revised
Drug use scale-revised
Substance abuse treatment scale
Timeline followback calandar
Secondary Outcome Measures
Full Information
NCT ID
NCT00043693
First Posted
August 12, 2002
Last Updated
August 7, 2012
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00043693
Brief Title
Family Intervention for Mental Illness and Substance Abuse
Official Title
Family Intervention for SMI and Substance Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
This study will evaluate a family intervention program for individuals with bipolar disorder, schizophrenia, or schizoaffective disorder and co-occurring substance use disorders.
Detailed Description
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.
Patients 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Substance-related Disorders
Keywords
Psychotic Disorders, Schizoaffective Disorder, Substance Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will undergo the Family Intervention for Dual Diagnosis (FIDD) program.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will be placed in a family psychoeducation program.
Intervention Type
Behavioral
Intervention Name(s)
Family Intervention for Dual Diagnosis
Intervention Description
The family intervention for dual diagnosis program lasts for up to 3 years and includes both single and multiple-family group formats.
Intervention Type
Behavioral
Intervention Name(s)
Family psychoeducation program
Intervention Description
The family psychoeducation program consists of 6 weekly sessions.
Primary Outcome Measure Information:
Title
Alcohol use scale-revised
Time Frame
Measured at baseline, during treatment, and post-treatment
Title
Drug use scale-revised
Time Frame
Measured at baseline, during treatment, and post-treatment
Title
Substance abuse treatment scale
Time Frame
Measured at baseline, during treatment, and post-treatment
Title
Timeline followback calandar
Time Frame
Measured at baseline, during treatment, and post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have schizophrenia, schizoaffective disorder, or bipolar disorder
Have a current substance use disorder (within the past 6 months)
Are willing to have at least 4 hours of contact per week with family members or significant others
Plan to remain in the community
Have family members or significant others who consent to participate in the study and plan to remain in the community
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim T. Mueser, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shirley Glynn, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Clinics El Camino
City
Santa Fe Springs
State/Province
California
ZIP/Postal Code
90670-3691
Country
United States
Facility Name
North Suffolk Mental Health Association
City
Chelsea
State/Province
Massachusetts
ZIP/Postal Code
02150
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12046678
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.
Results Reference
background
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Family Intervention for Mental Illness and Substance Abuse
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