SchizophreniaNCT00043693
Family Intervention for Mental Illness and Substance Abuse
A study testing Family Intervention for Dual Diagnosis and Family psychoeducation program in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Substance-related Disorders
- What is being tested?
- Family Intervention for Dual Diagnosis and Family psychoeducation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2002to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Suffolk Mental Health Association
Chelsea, Massachusetts, 02150
Pacific Clinics El Camino
Santa Fe Springs, California, 90670-3691
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Bipolar Disorder, Substance-related Disorders
- Being tested
- Family Intervention for Dual Diagnosis, Family psychoeducation program
- Keywords
- Psychotic Disorders, Schizoaffective Disorder, Substance Abuse
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Substance-Related Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Intervention for Dual DiagnosisBehavioural
The family intervention for dual diagnosis program lasts for up to 3 years and includes both single and multiple-family group formats.
Family psychoeducation programBehavioural
The family psychoeducation program consists of 6 weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will undergo the Family Intervention for Dual Diagnosis (FIDD) program. Receives: Behavioral: Family Intervention for Dual Diagnosis |
| 2 | Active comparator | Participants will be placed in a family psychoeducation program. Receives: Behavioral: Family psychoeducation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use scale-revised
Measured: Measured at baseline, during treatment, and post-treatment
Drug use scale-revised
Measured: Measured at baseline, during treatment, and post-treatment
Substance abuse treatment scale
Measured: Measured at baseline, during treatment, and post-treatment
Timeline followback calandar
Measured: Measured at baseline, during treatment, and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2002 (estimated)
- Study startApr 2002
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kim T. Mueser, PhD, Principal investigator, Dartmouth-Hitchcock Medical CenterShirley Glynn, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043693
- Sponsor's protocol ID
- R01MH062629
- Other IDs
- R01MH062629, DSIR SE-CE
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2002
- Last updated
- 8 Aug 2012
- Results posted
- No
Publications
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.
PubMed 12046678
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Intervention for SMI and Substance Use Disorder
- ClinicalTrials.gov ID
- NCT00043693
- Acronym / sponsor ID
- R01MH062629
- Conditions
- Schizophrenia, Bipolar Disorder, Substance-related Disorders
- Keywords
- Psychotic Disorders, Schizoaffective Disorder, Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Family Intervention for Dual DiagnosisParticipants will undergo the Family Intervention for Dual Diagnosis (FIDD) program. |
| 2 | Active comparator | Behavioral: Family psychoeducation programParticipants will be placed in a family psychoeducation program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Intervention for Dual DiagnosisThe family intervention for dual diagnosis program lasts for up to 3 years and includes both single and multiple-family group formats. | Behavioural | 1 |
| Family psychoeducation programThe family psychoeducation program consists of 6 weekly sessions. | Behavioural | 2 |
Primary outcome
Alcohol use scale-revised
Time frame: Measured at baseline, during treatment, and post-treatment
Drug use scale-revised
Time frame: Measured at baseline, during treatment, and post-treatment
Substance abuse treatment scale
Time frame: Measured at baseline, during treatment, and post-treatment
Timeline followback calandar
Time frame: Measured at baseline, during treatment, and post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Background: PubMed 12046678Mueser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim T. Mueser, PhD principal investigator
Dartmouth-Hitchcock Medical Center
Shirley Glynn, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Intervention for Dual Diagnosis and Family psychoeducation program in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use scale-revised (time frame: Measured at baseline, during treatment, and post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00043693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.