Family Intervention for Mental Illness and Substance Abuse

Schizophrenia Clinical Trial

Official title:

Family Intervention for SMI and Substance Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043693
• Other study ID #: R01MH062629
• Secondary ID: R01MH062629DSIR
• Status: Completed
• Phase: N/A
• First received: August 12, 2002
• Last updated: August 7, 2012
• Start date: April 2002
• Est. completion date: December 2008

Study information

• Verified date: August 2012
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Schizophrenia
• Substance-related Disorders

Intervention

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.
• Family psychoeducation program
The family psychoeducation program consists of 6 weekly sessions.

Locations

Country	Name	City	State
United States	North Suffolk Mental Health Association	Chelsea	Massachusetts
United States	Pacific Clinics El Camino	Santa Fe Springs	California

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol use scale-revised		Measured at baseline, during treatment, and post-treatment	No
Primary	Drug use scale-revised		Measured at baseline, during treatment, and post-treatment	No
Primary	Substance abuse treatment scale		Measured at baseline, during treatment, and post-treatment	No
Primary	Timeline followback calandar		Measured at baseline, during treatment, and post-treatment	No