Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000336583
Ethics application status
Not yet submitted
Date submitted
26/07/2006
Date registered
8/08/2006
Date last updated
8/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Caregiving in Early Psychosis with a Substance Use Disorder (SUD): The role of caregiver attributions in predicting caregiver appraisals, styles of coping and patient outcomes.
Scientific title
Caregiving in Early Psychosis with a Substance Use Disorder (SUD): The role of caregiver attributions in predicting caregiver appraisals of causality and controllability, styles of coping, patient outcomes and service contacts.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caregivers of young people with an Early Psychosis 1306 0
Early Psychosis 1307 0
Substance Use 1308 0
Condition category
Condition code
Mental Health 1396 1396 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of caregivers of young people with an Early Psychosis
Observation of number of service contacts over a six month period
Intervention code [1] 1229 0
Other interventions
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1901 0
Primary Outcome name: Level of patient substance use
Timepoint [1] 1901 0
Baseline
Primary outcome [2] 1902 0
Primary Outcome name: Causal Models Questionnaire for Schizophrenia score
Timepoint [2] 1902 0
Baseline
Primary outcome [3] 1903 0
Primary Outcome name: General Health Questionnaire score
Timepoint [3] 1903 0
Baseline
Primary outcome [4] 1904 0
Primary Outcome name: Ways of Coping Questionnaire score
Timepoint [4] 1904 0
Baseline
Primary outcome [5] 1905 0
Primary Outcome name: Family Questionnaire score
Timepoint [5] 1905 0
Baseline
Secondary outcome [1] 3366 0
Number of service contacts
Timepoint [1] 3366 0
Baseline, three months, six months
.
Secondary outcome [2] 3367 0
Patient level of functioning
Timepoint [2] 3367 0
Baseline, three months, six months
.

Eligibility
Key inclusion criteria
Patients will be experiencing their first episode of psychosis.
Caregiver of a young person with Early Psychosis.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient: Not fluent in English, diagnosed intellectual disability or do not have an identified caregiver.
Care giver: lack of fluency in English, an intellectual disability, or an acute psychiatric illness.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1530 0
University
Name [1] 1530 0
Monash University
Country [1] 1530 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 1344 0
Hospital
Name [1] 1344 0
Barwon Health
Address [1] 1344 0
Country [1] 1344 0
Australia

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35850 0
Address 35850 0
Country 35850 0
Phone 35850 0
Fax 35850 0
Email 35850 0
Contact person for public queries
Name 10418 0
Kerrie Clarke
Address 10418 0
Department of Psychology
Building 17
Monash University VIC 3800
Country 10418 0
Australia
Phone 10418 0
+61 419138596
Fax 10418 0
Email 10418 0
[email protected]
Contact person for scientific queries
Name 1346 0
Dr. Grace Couchman
Address 1346 0
Department of Psychology
Building 17
Monash University VIC 3800
Country 1346 0
Australia
Phone 1346 0
+61 3 95487011
Fax 1346 0
+61 3 95487009
Email 1346 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.