Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000175673
Ethics application status
Approved
Date submitted
12/12/2013
Date registered
12/02/2014
Date last updated
12/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
YES: Youth Early-Intervention Study in Functional Recovery
Scientific title
a randomised longitudinal cross-over design trial of early intervention programs for youth (aged 14-25) engaged with the Youth Mental Health Clinic (YMHC) at BMRI, University of Sydney, to improve social functioning as measured by Social and Occupational Functioning Scale .
Secondary ID [1] 283079 0
nil known
Universal Trial Number (UTN)
Trial acronym
YES: Youth Early-Intervention Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health
mood disorders and psychoses
 289918 0
Condition category
Condition code
Mental Health 291439 291439 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The YES intervention program consists of 3 eight week terms over a year. Between each term is a 3 week washout period, when the intervention programs are not run.

This randomised, crossover, longitudinal study has two arms. Each arm of the trial requires 4 hours per week or 32 hours of treatment over a 8 week period. The treatment period consists of 16 weeks with a 3 week washout period between treatment arms.

arm A: randomised as an "A"
This arm of the trial focuses on social interaction and well being.
There are two weekly interventions: anxious art(2.5 hrs) and Buddhist Mindfulness (1.5hrs) Participants can attend one or both of the workshops within their stream. Interventions are based on social exposure principals which encourage and support participants to practise self soothing and coping strategies and promote illness insight, reduction in disorder symptoms.

Adherence to the program is encouraged through weekly text and e-mail reminders about intervention times and venues. Attendance, per intervention session is collected and included in the main data base.

Study measures are collected at baseline prior to randomisation, week 1 of the term and are repeated at week 8 of the term. After the washout period, measures are again repeated at week one and week eight of the second intervention period. Follow up is at 12 months
Intervention code [1] 287795 0
Treatment: Other
Intervention code [2] 287796 0
Behaviour
Intervention code [3] 287797 0
Lifestyle
Comparator / control treatment
The YES intervention program consists of 3 eight week terms over a year. Between each term is a 3 week washout period, when the intervention programs are not run.

This randomised, crossover, longitudinal study has two arms. Each arm of the trial requires 4 hours per week or 32 hours of treatment over a 8 week period. The treatment period consists of 16 weeks with a 3 week washout period between treatment arms.

Arm "B": randomised as "B"
This arm of the trial focuses on physical health and well being. There are two weekly interventions: Tennis (2.5hrs) and cardio-boxing (1.5 hrs). Participants can attend one or both of the interventions within their stream. Central to intervention B is physical activity. Participants look to improve general fitness levels as well as understand how physical exercise impacts on their illness management skills. Interventions also promote self-soothing and coping strategies, promote illness insight and a reduction in disorder symptoms.

Adherence to the program is encouraged through weekly text and e-mail reminders about intervention times and venues. Attendance, per intervention session is collected and included in the main data base.

Study measures are collected at baseline prior to randomisation, week 1 of the term and are repeated at week 8 of the term. After the washout period of three weeks between interventions, measures are again repeated at week one and week eight of the second intervention term. Follow up is at 12 months
Control group
Active

Outcomes
Primary outcome [1] 290318 0
Primary outcome: reduce the levels of social disability associated with the progression of mental illness.
primary outcome measure: Social Occupational Functioning Assessment Scale (SOFAS). Initial assessment using this scale is done by the Trial Researcher. The following SOFAs at week one and week 8 of the intervention terms, and at 12 month follow up, are completed by the participants treating doctor/clinician.
Timepoint [1] 290318 0
The same self report measures (mood, metabolic, symptom, disability and social functioning) are used throughout the trial period. The SOFAs is measured by the participant's treating doctor/clinician (not the trial researcher). Measures are taken at base line and then repeated at week one of the intervention, week eight of the intervention. After the three week washout period when participants crossover to the second intervention, measures are repeated at week one and week eight of the second term. Follow up is at 12 months.
Secondary outcome [1] 304301 0
validate the FAST (Functioning Assessment Short Tool) for a youth population, across mental health diagnosis
Timepoint [1] 304301 0
participants will be asked to fill in a self report at baseline prior to randomisation and at week one and week 8 of each term. Participants will be encouraged to attend for two terms which would result in 5 self reports, one follow up measure.

Eligibility
Key inclusion criteria
Help seeking young people aged between 14 and 25 with mood disorder/psychosis who have increased Cardio Metabolic Syndrome risk factors, social and cognitive difficulties as determined by their treating doctor/clinician. Must speak fluent english
Minimum age
14 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
suffer from intellectual disability, major neurological disorder, or a major medical illness which impacts on cognition; history of sustained head injury; poor english skills; florid psychotic symptoms/florid mania; likely to require acute clinical care; current substance dependance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed.

Once consent has been obtained, participants have been deemed eligible to enter the trial and baseline measures have been completed, they will be randomised into one of the treatment arms using the computerised random number generator program, www.graphpad.com. Staff responsible for establishing randomisation procedures will not be involved in the day to day running of the trial. Research staff will not be aware of group membership during the baseline assessments as randomisation occurs after this stage.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a simple method of randomisation is used to assign participants to the two arms of the study. www.graphpad.com creates a randomised table of allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The YES treatment trial aims to recruit 120 participants over a two year data collection period. Other similar studies on social functioning and youth have small sample sizes (N= less then 20). In response to these studies, a sample size of 60 was determined to have the power to detect a moderate effect size.

All data will be entered into and analysed descriptively using SPSS, version 21 (SPSSS Inc, Chicago, Ill, USA). Pearson correlations will be used for continuous data. ANOVA or t-tests will be used for comparisons between the two arms of the study. Logistic regression will be used to determine whether demographic and/or clinical variables predict any difference between the two arms of the study. As this research takes place in a health service setting; with participants, clinicians and health care staff providing information, there will be variables of missing data.

Primary analyses will be undertaken on the standard and widely accepted intention to treat basis including all participants randomised regardless of treatment actually recieved or withdrawl from the study. The primary outcome is the changes in the SOFAS score over time. Further analyses will evaluate the maintenance of their difference over the subsequent 6 months and at 12 months. Mixed model repeated measures analyses will be used because of the ability of this approach to include participants with missing data without using discredited techniques such as last observation carried forward. As a sensitivity analysis multiple imputation using demographic and other background variables as predictors will be used to allow inclusion of data from all participants. Additional analyses will explore participant characteristics which moderate outcome and, if appropriate, levels of presenting severity associated with significant improvement.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/02/2012
Actual
10/02/2012
Date of last participant enrolment
Anticipated
18/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7287 0
2040 - Leichhardt

Funding & Sponsors
Funding source category [1] 287839 0
University
Name [1] 287839 0
University of Sydney
Brain and Mind Research Institute
Country [1] 287839 0
Australia
Primary sponsor type
Individual
Name
Professor Ian Hickie
Address
Brain and Mind Research Institute
100 Mallet Street
Camperdown, NSW
Australia,2050
Country
Australia
Secondary sponsor category [1] 286564 0
Individual
Name [1] 286564 0
Ms. Jeanne Gehue
Address [1] 286564 0
Brain and Mind Research Institute
100 mallet Street
Camperdown, NSW
Australia, 2050
Country [1] 286564 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This randomised, within subject, longitudinal trial will determine the efficacy of Functional Remediation as an early intervention in young people with mood disorder/psychosis who have increased Cardio Metabolic Syndrome risk factors and cognitive difficulties, as determined by their referring clinician. Specifically this trial aims to demonstrate that Functional Remediation will:
aim 1: improve quality of life in young outpatients with a mood disorder/psychoses
aim 2: improve mental health by delaying progression of illness and promote longer periods between lapse/relapse
aim 3: modify sleep-wake behaviour, mood and general health (targeting cardio-metabolic outcomes) to improve social educational and functional skills, educational/employment/retention/return
aim 4: to examine the role of change in cardio-metabolic characteristics with the cohort and following the intervention
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42390 0
Prof Ian Hickie
Address 42390 0
Brain and Mind Research Institute,
University of Sydney
100 Mallet Street
Camperdown, NSW
Australia, 2050
Country 42390 0
Australia
Phone 42390 0
+61 2 9144 4100
Fax 42390 0
Email 42390 0
ian.hickie@sydney.edu.au
Contact person for public queries
Name 42391 0
Lillian Jean Gehue
Address 42391 0
Brain and Mind Research Institute
University of Sydney
100 Mallet Street, Camperdown, NSW
Australia, 2050
Country 42391 0
Australia
Phone 42391 0
+61 (0) 411 265 728
Fax 42391 0
Email 42391 0
gehue@icloud.com
Contact person for scientific queries
Name 42392 0
Lillian Jean Gehue
Address 42392 0
Brain and Mind Research Institute
University of sydney
100 Mallet Street,
Camperdown, NSW
Australia, 2050
Country 42392 0
Australia
Phone 42392 0
+61 2 9144 4100
Fax 42392 0
Email 42392 0
gehue@icloud.com

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No Supporting Document Provided



Results publications and other study-related documents

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