Family Intervention for Mental Illness and Substance Abuse - Tabular View

Tracking Information

First Received Date ^ICMJE

August 12, 2002

Last Updated Date

September 29, 2008

Start Date ^ICMJE

April 2002

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Alcohol use scale-revised [ Time Frame: Measured at baseline, during treatment, and post-treatment ] [ Designated as safety issue: No ]
Drug use scale-revised [ Time Frame: Measured at baseline, during treatment, and post-treatment ] [ Designated as safety issue: No ]
Substance abuse treatment scale [ Time Frame: Measured at baseline, during treatment, and post-treatment ] [ Designated as safety issue: No ]
Timeline followback calandar [ Time Frame: Measured at baseline, during treatment, and post-treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00043693 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Family Intervention for Mental Illness and Substance Abuse

Official Title ^ICMJE

Family Intervention for SMI and Substance Use Disorder

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Schizophrenia
Bipolar Disorder
Substance-Related Disorders

Intervention ^ICMJE

Behavioral: Family Intervention for Dual Diagnosis
Behavioral: Family psychoeducation program

Study Arms / Comparison Groups

Experimental: Participants will undergo the Family Intervention for Dual Diagnosis (FIDD) program.
Active Comparator: Participants will be placed in a family psychoeducation program.

Publications *

Mueser KT, Fox L. A family intervention program for dual disorders. Community Ment Health J. 2002 Jun;38(3):253-70.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

140

Estimated Completion Date

January 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00043693

Responsible Party

Kim T. Mueser, PhD, Dartmouth Medical School

Study ID Numbers ^ICMJE

R01 MH62629, DSIR SE-CE

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Kim T. Mueser, PhD	Dartmouth-Hitchcock Medical Center
Principal Investigator:	Shirley Glynn, PhD	University of California, Los Angeles

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP