NCT00435721

Brief Summary

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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
Last Updated

February 15, 2007

Status Verified

January 1, 2007

First QC Date

February 14, 2007

Last Update Submit

February 14, 2007

Conditions

Keywords

schizophreniafamily psychoeducation

Outcome Measures

Primary Outcomes (3)

  • Family knowledge

  • Family Burden

  • Expressed emotion

Secondary Outcomes (4)

  • Social Support

  • Coping Strategies

  • Confidence in knowledge

  • Use of community resources

Interventions

PsychoeducationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Own diagnosis of schizophrenia /schizoaffective disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02448, United States

Location

Freedom Trail Clinic North Suffolk Mental Health Association

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Michelle S. Friedman-Yakoobian, Ph.D.

    Massachusetts General Hospital, Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 15, 2007

Study Start

June 1, 2002

Study Completion

August 1, 2005

Last Updated

February 15, 2007

Record last verified: 2007-01

Locations