Families Coping With Mental Illness Program

February 14, 2007 updated by: North Suffolk Mental Health Association

The Families Coping With Mental Illness Program

The current study aims to develop and evaluate a practical, short-term support and education program for relatives of individuals with schizophrenia. This program has been developed to maximize efficiency and effectiveness in the following ways:

  1. The intervention specifically targets those factors empirically demonstrated to improve family functioning and well being. Specifically, this pilot intervention aims to: a) increase relatives' knowledge about schizophrenia spectrum disorders; b) help families attribute distressing behaviors of their ill relatives more accurately, by helping them to distinguish behaviors that are directly related to the illness from personality characteristics; c) improve attitudes towards the patient and reduce stress in interactions with the patient; d) encourage problem-focused coping strategies; e) reduce burden; f) provide opportunities for relatives to expand their social support network; g) help families learn about and utilize community resources.
  2. The program involves both individual and multifamily group components, in order to reap the benefits of both formats. Specifically, multifamily psychoeducation groups (involving individuals from several different families) tend to be more economical and allow participants to learn from each other, increase their social support networks, and reduce feelings of stigma. In contrast, individualized programs can target the specific needs of participants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Format of intervention:

The program contains the following components:

Four multiple family group sessions:

  • Session 1: Understanding the illness
  • Session 2: Treatments and community resources
  • Session 3: Coping with the illness

  • Session 4: Reducing stress in the family

    2. Two individual consultation sessions with the group leader (occurring before and after the group) The principal investigator will conduct all group and individual sessions. Since the intervention is brief, emphasis is placed on introducing concepts and helping relatives learn how to obtain more information for themselves, rather than on practicing and adopting all skills that are introduced. Materials are provided to read between sessions to supplement the didactic presentations and allow maximum time for relatives to discuss how topics relate to their personal experiences. In addition, group members are asked each week to report on how they applied strategies discussed in the group and whether or not they found them to be effective.

Subjects:

The participants in this study will be a minimum of 50 adult relatives of individuals with schizophrenia or schizoaffective disorder. Up to three relatives per family may participate in the program. Groups will contain between 4 and 10 people from a minimum of three families.

Procedure:

Assessments, consultations, and groups will take place at McLean Hospital or the Freedom Trail Clinic to prevent external environmental influences from affecting data collection and to ensure that the interviews will be held in a confidential location. A wait-list control design will be used to evaluate the efficacy of this intervention. Clients will be assessed initially on a number of dimensions (specified below) by a trained, reliable research assistant. These clients will be randomly assigned to either an intervention (psychoeducation right away) or a wait-list control condition . The psychoeducation program will consist of four weekly, 2 ½ -hour multifamily group sessions and two individualized pre- and post-group consultation sessions. Clients in the control condition will receive psychoeducation after the intervention group has completed the program. Upon completion of the psychoeducation program, a research assistant will re-evaluate relatives in both the intervention and the wait-list control group. To minimize interviewer bias, this research assistant will be blind to which condition (intervention or wait-list) the clients were assigned.

Measures:

Self-report instruments and audiotaped structured interviews included in the pre- and post-intervention assessments will measure knowledge about schizophrenia, coping strategies, perceived burden, expressed emotion, attribution of illness symptoms and behaviors, quality and use of social support network, and depression and anxiety among participants. Participants will also be asked to provide demographic information such as age, ethnicity, socioeconomic status, relationship to patient (e.g., parent, sibling), and living situation (whether or not participant resides with patient). Participants who do not live with patients will be asked to identify the number of hours per week spent in caregiving activities (e.g., assistance with activities of daily living or providing companionship). In addition, the post-intervention assessment will include some measures of client satisfaction. (Copies of all measures are attached).

Specific hypothesis:

Compared to wait list control subjects, subjects who have participated in the intervention will show decreased levels of perceived burden, depression, anxiety, high expressed emotion, and attributions of control. Furthermore, they will exhibit increased knowledge regarding the illness, use of community resources, and perceived social support.

10. Duration of the study and the subject's involvement in the study: Subject participation in this study will be approximately 6 weeks for the intervention group and 12 weeks for the wait list group. Subjects in the intervention group will come to McLean 6 times (two interview and consultation sessions and four educational sessions). Subjects in the wait list group will come to McLean 7 times (this includes one additional interview session after the wait list period, before starting the group). The duration of the study is expected to be at least 1 year. We would like to continue recruiting subjects until a least 50 subjects have participated.

Study Type

Interventional

Enrollment

50

Phase

  • Phase 1

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
    • Massachusetts
      • Belmont, Massachusetts, United States, 02448
        • McLean Hospital
      • Boston, Massachusetts, United States, 02114
        • Freedom Trail Clinic 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Self identified family members of individuals with schizophrenia or schizoaffective disorder or psychosis NOS
  • 18 years old or over

Exclusion Criteria:

  • Own diagnosis of schizophrenia /schizoaffective disorder

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: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Family knowledge
Family Burden
Expressed emotion

Secondary Outcome Measures

Outcome Measure
Social Support
Coping Strategies
Confidence in knowledge
Use of community resources

Collaborators and Investigators

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

Sponsor

North Suffolk Mental Health Association

Collaborators

Mclean Hospital

Investigators

  • Principal Investigator: Michelle S. Friedman-Yakoobian, Ph.D., Massachusetts General Hospital, Beth Israel Deaconess Medical Center

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

June 1, 2002

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (Estimate)

February 15, 2007

Study Record Updates

Last Update Posted (Estimate)

February 15, 2007

Last Update Submitted That Met QC Criteria

February 14, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORRC 03-2003

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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