Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000265976p
Ethics application status
Submitted, not yet approved
Date submitted
31/01/2020
Date registered
28/02/2020
Date last updated
28/02/2020
Date data sharing statement initially provided
28/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised waitlist-controlled study investigating a psychosocial life skills program called Thrive, for young adults 18 to 25 years with chronic illness.
Scientific title
A pilot randomised waitlist-controlled study investigating a psychosocial life skills program called Thrive, for young adults 18 to 25 years with chronic illness.
Secondary ID [1] 300408 0
Nil known
Universal Trial Number (UTN)
U1111-1247-5898
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic illness 316051 0
Social isolation 316052 0
Condition category
Condition code
Mental Health 314325 314325 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of six weekly full-day sessions (5 hours) with a two-hour pre-program orientation and a one-month post-program reunion. The weekly sessions includes a morning experiential workshop, followed by cooking (lunch) then a creative and reflective afternoon session. The current program encompasses a strengths-based, arts-integrated, and developmentally informed framework with acceptance commitment therapy integration. The program has been redesigned based on feedback from young people to meet additional needs of understanding self and connecting with others. The current content and format is manualised for standardised delivery.
It will be delivered by occupational therapists in groups in a Young Adult Health Centre at a Hospital.
Fidelity to the intervention will be through a manual of the intervention and check-lists after each session.
Week 1 - welcome, expectations and activities
Week 2 - introduction to acceptance commitment framework using Zone of regulation, DNA-V and experiential application
Week 3 - who I am, worldviews and culture. Activities to understand myself and identity
Week 4 - Identifying my strengths, activities and artwork
Week 5 - Social skills through experiential activities requiring social cooperation and love language
Week 6 - Social Skills, basic skills. Activities designed to practice social skills
Week 7 - stress management, use of sensory modalities
Week 8 - wrap up, feedback and activities. Goal setting
Intervention code [1] 316698 0
Lifestyle
Comparator / control treatment
The comparator is a wait list control. Participants in the wait list control group will receive treatment as usual with clinical support. After the 12 week follow-up (week 23), they will then be offered the intervention program.
Control group
Active

Outcomes
Primary outcome [1] 322702 0
Paediatric Quality of Life Inventory (PedsQL 4.0).
Timepoint [1] 322702 0
We will be assessing the primary outcome at week 7, week 11 and week 23 (12 weeks post-treatment), with week 23 as the primary time point.
Secondary outcome [1] 379355 0
Social Connectedness Scale- Revised (SCS-R)
Timepoint [1] 379355 0
Week 23 (12 weeks post-treatment)
Secondary outcome [2] 379356 0
Perceived Stress Scale 10 item version (PSS-10)
Timepoint [2] 379356 0
Week 23 (12 weeks post-treatment)
Secondary outcome [3] 379357 0
The tool used to measure illness management is the Engagement in Health Questionnaire. This is a brief set of questions developed by our research team based on the MARS, a well recognised medication and health engagement questionnaire.
Timepoint [3] 379357 0
Week 12 post-treatment (i.e week 23)

Eligibility
Key inclusion criteria
• Young Adult (16 to 25 years)
• Have a chronic health condition or disability
• Have a primary specialist at the Mater Adult Hospital
• Able to verbally communicate and write in English
• Able to give informed consent
• Have access to an internet enabled device
• Able to commit to attend the eight face to face Thrive program sessions
• Willing to participate in surveys and focus groups
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals with moderate to severe intellectual disabilities as program content does not suit this cohort
• Individuals with major mental illness (e.g. current psychotic symptoms, current PTSD) as symptoms and treatment will likely interfere with their ability to participate in the program
• Individuals with current alcohol and drug dependency as substance dependence will likely impact on program participation
• Individuals enrolled or participating in another psychological therapy study during the program as this will impact study data
• Individuals from regional and remote locations as weekly face to face attendance is required for the Thrive program
• Individuals with infection control concerns due to medical and pragmatic limitations and safety risks
• Individuals with mobility restrictions that limit their ability to access and attend the program (e.g. requiring one or more person assist for transfers and mobilising)
• Previous experience or attendance in the Thrive program (even in its early development) as this would impact scientific integrity

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be through our statistician who is not involved in the clinical care or recruitment of participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is quality of life based on the PedsQL 4.0 total score which will be assessed at week 7, week 11 and at week 23 (12-weeks following treatment) with the week 23 as the primary time point. Group sample sizes of 64 (treatment) and 64 (waitlist control) would be required to achieve 80% power to reject the null hypothesis of equal means with a population mean difference of 5.0 (considered to be a clinically important difference), a standard deviation (SD) of 10.0 and a significance level (alpha) of 0.05 using a two-sided two-sample equal variance t-test. Given that the dropout rate is expected to be approximately 20%, approximately 80 participants would need to be recruited to each group to achieve the stated power.
Larger SDs have been reported for the PedsQL 4.0 18-25 subscales: using a SD of 17.0 sample size would need to be increased to 183 (treatment) and 183 (control) to detect a difference of 5.0 in the subscales.
This is a pilot study and as such is not powered to find a statistically significant difference between groups unless larger than expected differences are seen. Results will be used to update sample size calculations for a larger study.
In keeping with pilot study sample size guidelines of at least 40 and effectiveness studies of 30 participants per arm, this pilot will propose a sample size of 60. Sixty-four participants will be recruited to account for drop-out.

Intention to treat analysis will be utilised when comparing groups. Two-sided two-sample t-tests and analysis of covariance adjusting for baseline scores will be used to compare PedsQL scores between treatment and control groups at week 7 and at the 12-week follow up (week 23).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/03/2020
Actual
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15720 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 29141 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304831 0
Charities/Societies/Foundations
Name [1] 304831 0
BiCare Grant from the Mater Foundation.
Country [1] 304831 0
Australia
Primary sponsor type
Hospital
Name
Mater Young Adult Health Centre
Address
Level 5 Potter Link
Mater Annerley Road Campus
South Brisbane
Qld 4101
Country
Australia
Secondary sponsor category [1] 305163 0
None
Name [1] 305163 0
Address [1] 305163 0
Country [1] 305163 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305242 0
The Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 305242 0
Level 3 Ambigny Place
Raymond Tce
South Brisbane QLD 4101
Ethics committee country [1] 305242 0
Australia
Date submitted for ethics approval [1] 305242 0
03/02/2020
Approval date [1] 305242 0
Ethics approval number [1] 305242 0

Summary
Brief summary
This study will evaluate the effectiveness of a psychosocial life skills program by measuring improvements in quality of life (standard of health, comfort and happiness), social connectedness (the relationship people have with others), and perceived stress (the degree to which situations are seen as stressful). Participants will be randomised into one of two groups; the intervention (being the Thrive program attendees who consent to take part in the study) or the waitlist-control (people waiting to be enrolled in a Thrive program).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99738 0
Ms Esther van Raalte
Address 99738 0
Mater Young Adult Health Centre Brisbane
Level 5 Potter Link
Mater Annerley Road Campus
South Brisbane
Qld 4101
Country 99738 0
Australia
Phone 99738 0
+61 7 3163 6000
Fax 99738 0
Email 99738 0
[email protected]
Contact person for public queries
Name 99739 0
Ms Esther van Raalte
Address 99739 0
Mater Young Adult Health Centre Brisbane
Level 5 Potter Link
Mater Annerley Road Campus
South Brisbane
Qld 4101
Country 99739 0
Australia
Phone 99739 0
+61 7 3163 6000
Fax 99739 0
Email 99739 0
[email protected]
Contact person for scientific queries
Name 99740 0
A/Prof Simon Denny
Address 99740 0
Mater Young Adult Health Centre Brisbane
Level 5 Potter Link
Mater Annerley Road Campus
South Brisbane
Qld 4101
Country 99740 0
Australia
Phone 99740 0
+61 731637123
Fax 99740 0
Email 99740 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot study and small numbers


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6686Study protocol  [email protected]



Results publications and other study-related documents

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

Documents added automatically
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