Clinical trial NCT00940394: Effectiveness of Family Group Interventions for People With Schizophrenia
Official title: Evaluation of the Effects of Mutual Support and Psycho-educational Group Interventions for Family Caregivers of People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: mutual support group
psychoeducation group
family caregivers
schizophrenia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2009-07-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* family caregivers lived with and cared for one family member diagnosed with schizophrenia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; American Psychiatric Association, 1994)
* family caregivers were at least 18 years of age and could understand and read the Chinese (Mandarin) language; and
* family caregivers were free from any mental illness themselves.

Exclusion Criteria:

* the patients with schizophrenia suffered no co-morbidity due to other mental illness during recruitment to the study
* family caregivers cared for more than one family member with mental or chronic physical illness; and/or
* family caregivers had been the primary carers for less than three months

Primary outcomes:
measure: length of re-hospitalizations
timeFrame: at recruitment, six-month, 18-month and 36-month post-intervention
Secondary outcomes:
measure: families' perceived social support
timeFrame: at recruitment, six-month, 18-month and 36-month post-intervention
measure: patients' symptom severity
timeFrame: at recruitment, six-month, 18-month and 36-month post-intervention
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Li Ka Shing Specialty OPD
state: NT
city: Taipo
country: Hong Kong
facility: AHNH Psychiatric OPD
state: NT
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Chien Wai-Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/s10464-008-9178-8.
citation: Chien WT, Thompson DR. An RCT with three-year follow-up of peer support groups for Chinese families of persons with schizophrenia. Psychiatr Serv. 2013 Oct;64(10):997-1005. doi: 10.1176/appi.ps.201200243.
citation: Chien WT, Chan SW. The effectiveness of mutual support group intervention for Chinese families of people with schizophrenia: a randomised controlled trial with 24-month follow-up. Int J Nurs Stud. 2013 Oct;50(10):1326-40. doi: 10.1016/j.ijnurstu.2013.01.004. Epub 2013 Feb 19.
citation: Chien WT, Bressington D, Chan SWC. A Randomized Controlled Trial on Mutual Support Group Intervention for Families of People With Recent-Onset Psychosis: A Four-Year Follow-Up. Front Psychiatry. 2018 Dec 18;9:710. doi: 10.3389/fpsyt.2018.00710. eCollection 2018.