Family Intervention for Mental Illness and Substance Abuse

August 7, 2012 updated by: Dartmouth-Hitchcock Medical Center

Family Intervention for SMI and Substance Use Disorder

This study will evaluate a family intervention program for individuals with bipolar disorder, schizophrenia, or schizoaffective disorder and co-occurring substance use disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Fe Springs, California, United States, 90670-3691
        • Pacific Clinics El Camino
    • Massachusetts
      • Chelsea, Massachusetts, United States, 02150
        • North Suffolk Mental Health Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will undergo the Family Intervention for Dual Diagnosis (FIDD) program.
Behavioral: Family Intervention for Dual Diagnosis
The family intervention for dual diagnosis program lasts for up to 3 years and includes both single and multiple-family group formats.
Active Comparator: 2
Participants will be placed in a family psychoeducation program.
Behavioral: Family psychoeducation program
The family psychoeducation program consists of 6 weekly sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alcohol use scale-revised
Time Frame: Measured at baseline, during treatment, and post-treatment
Measured at baseline, during treatment, and post-treatment
Drug use scale-revised
Time Frame: Measured at baseline, during treatment, and post-treatment
Measured at baseline, during treatment, and post-treatment
Substance abuse treatment scale
Time Frame: Measured at baseline, during treatment, and post-treatment
Measured at baseline, during treatment, and post-treatment
Timeline followback calandar
Time Frame: Measured at baseline, during treatment, and post-treatment
Measured at baseline, during treatment, and post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 12, 2002

First Submitted That Met QC Criteria

August 14, 2002

First Posted (Estimate)

August 15, 2002

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH062629 (U.S. NIH Grant/Contract)
  • DSIR SE-CE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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