NCT00940394

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

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

January 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

4.7 years

First QC Date

July 15, 2009

Last Update Submit

August 19, 2014

Conditions

Keywords

mutual support grouppsychoeducation groupfamily caregiversschizophrenia

Outcome Measures

Primary Outcomes (1)

  • length of re-hospitalizations

    at recruitment, six-month, 18-month and 36-month post-intervention

Secondary Outcomes (2)

  • families' perceived social support

    at recruitment, six-month, 18-month and 36-month post-intervention

  • patients' symptom severity

    at recruitment, six-month, 18-month and 36-month post-intervention

Study Arms (3)

standard care

OTHER

Families receive routine community and family mental health care services

Other: Standard care

mutual support group

EXPERIMENTAL

bi-weekly, 12-session, family-led mutual support group

Behavioral: mutual support group

psychoeducation group

ACTIVE COMPARATOR

bi-weekly, 12-session, family psychoeducation group program

Behavioral: psychoeducation group

Interventions

bi-weekly, 12-session, family-led mutual support group

Also known as: FMSG
mutual support group

bi-weekly, 12-session, family psychoeducation group

Also known as: FPGP
psychoeducation group

Routine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia

Also known as: Usual psychiatric care
standard care

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Li Ka Shing Specialty OPD

Shatin, NT, Hong Kong

Location

AHNH Psychiatric OPD

Taipo, NT, Hong Kong

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Chien Wai-Tong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 16, 2009

Study Start

January 1, 2007

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations