Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435721
Status:
UNKNOWN
Last Update Posted:
2007-02-15
First Post:
2007-02-14
Brief Title:
Families Coping With Mental Illness Program
Sponsor:
North Suffolk Mental Health Association
Organization:
North Suffolk Mental Health Association
Study Overview
Official Title:
The Families Coping With Mental Illness Program
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 eg 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 eg 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 subjects 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
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 eg 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 eg 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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None