Effectiveness of Family Group Interventions for People With Schizophrenia (MSG)
| Tracking Information | |||||
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| First Received Date ICMJE | July 15, 2009 | ||||
| Last Updated Date | August 15, 2012 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
length of re-hospitalizations [ Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
patients' symptom severity and length of re-hospitalizations [ Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00940394 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
families' perceived social support [ Time Frame: at recruitment, six-month, 18-month and 36-month post-intervention ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Family Group Interventions for People With Schizophrenia | ||||
| Official Title ICMJE | Evaluation of the Effects of Mutual Support and Psycho-educational Group Interventions for Family Caregivers of People With Schizophrenia | ||||
| Brief Summary | The mutual support group intervention would significantly improve the families' burden of care, functioning and social support, reduce the patients' severity of symptoms and re-hospitalizations, and reduce the demands for utilization of family services, when compared with the standard care group. |
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| Detailed Description | Family interventions in schizophrenia have shown positive effects on patients but little attention has been paid to their effects on family members, particularly those in non-Western countries. This multi-site randomized controlled trial evaluated the effectiveness of a bi-weekly, 12-session, family-led mutual support group for Chinese caregivers of schizophrenia sufferers over 36 months, compared with a family psychoeducation group program and standard psychiatric care. It was conducted with 114 families of outpatients with schizophrenia in Hong Kong of whom 38 were assigned randomly to a mutual support group, a psychoeducation group, or standard care. Families' psychosocial health status and patients' symptom severity and length of re-hospitalizations at recruitment, one-month, 18-month, and 36-month post-intervention were compared between groups. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Chien WT, Thompson DR, Norman I. Evaluation of a peer-led mutual support group for Chinese families of people with schizophrenia. Am J Community Psychol. 2008 Sep;42(1-2):122-34. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 128 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Hong Kong | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00940394 | ||||
| Other Study ID Numbers ICMJE | 216020 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Chien Wai-Tong, The Hong Kong Polytechnic University | ||||
| Study Sponsor ICMJE | The Hong Kong Polytechnic University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Hong Kong Polytechnic University | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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