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Trial registered on ANZCTR


Registration number
ACTRN12615000455561
Ethics application status
Approved
Date submitted
1/04/2014
Date registered
11/05/2015
Date last updated
10/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Young and Well Collaborative Research Centre (YAWCRC) - What is the usability, acceptability and impact of the 'Keep It Real' website, for young cannabis users with psychotic-like experiences?
Scientific title
What is the usability, acceptability and impact of the 'Keep It
Real' website, for young cannabis users with psychotic-like experiences?
Secondary ID [1] 283797 0
Nil
Universal Trial Number (UTN)
U1111-1153-8717
Trial acronym
‘‘Keep it Real’’ Website Evaluation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis use with psychotic-like experiences amongst young people 290775 0
Condition category
Condition code
Mental Health 291138 291138 0 0
Addiction
Mental Health 294869 294869 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'Keep it Real' website will be evaluated by young Australians (16-25) who have used cannabis in the past month and have has a Psychotic-Like Experiences (PLEs). The outcome variables, cannabis use and the rate of PLEs, will be assessed at baseline for the treatment group, one month for the delayed group and three and six month for both groups.

The ‘Keep it Real’ website consists of 6 modules as well as a page of contact details for resources a participant could use if they need to seek help. The modules include:
1. What are ‘weird experiences'?
2. Why it is happening?
3. What are the types of weird experiences?
4. How does cannabis affect me?
5. How can I deal with stuff?
6. Should I seek help?

Each module should take a participant approximately 10 minutes or less to complete. The total time to complete all modules is expected to be 1 hour or less.

Participants will be asked to complete the 'Keep it Real' program within one month. They will have six months access to the website. During this time data will be collected about the use of the 'Keep it Real' website. Participants are able to access the website as much as they want once they have their login details.

Participants will be sent a message (SMS text message or email) once a week for the first month of the trail to remind them to complete the program. A maximum of three reminder emails will be sent for each follow up survey at the 1 month, 2 month, 3 month and 6 month follow-ups.
Intervention code [1] 288481 0
Lifestyle
Intervention code [2] 290982 0
Treatment: Other
Comparator / control treatment
A waitlist control will be used whereby 50% of the sample will be provided website access one month later than the experimental cohort.
Control group
Active

Outcomes
Primary outcome [1] 291125 0
Cannabis use in participants. This will be assessed via questions concerning the participants' alcohol and other drug use in the past month and via the the Alcohol, Smoking and Substance Involvement Screening Test.
Timepoint [1] 291125 0
Baseline;1, 3 and 6 months post.
Primary outcome [2] 292546 0
Number of PLEs experienced. PLEs will be assessed via the Community Assessment of Psychic Experience Questionnaire (CAPE); 3 month version.
Timepoint [2] 292546 0
3 months CAPE will be administered at Baseline (Treatment group), 1 month (delayed group); 3 months and 6 months (both groups).
Primary outcome [3] 292547 0
Knowledge of cannabis harm minimisation strategies. This is a measure designed specifically for the study. It is also being piloted within this study. It consists of nineteen questions to determine the presence and frequency of cannabis-related harm minimisation strategies used by the young person in the past month. Participants are to indicate whether they have used each strategy ‘Not at all’, ‘A bit’ or ‘A lot’.
Timepoint [3] 292547 0
Baseline; 1, 2, 3 and 6 months post.
Secondary outcome [1] 306053 0
Psychological distress.This will be assessed by both the Kessler Psychological Distress Scale (K10) and the short form of the Mental Health Continuum (MHC-SF).
Timepoint [1] 306053 0
Baseline; 1, 2, 3 and 6 months post.
Secondary outcome [2] 309199 0
Functioning. This will be assessed via the Assessment of Quality of Life Questionnaire (AQOL-6D).
Timepoint [2] 309199 0
Baseline and 3 months

Eligibility
Key inclusion criteria
1. Aged 16-25 years
2. Used cannabis at least once in the past month
3. Report having psychotic-like experiences in the past three months
Minimum age
16 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A current or past diagnosis of psychotic disorder
2. Current acute suicide risk
3. Lack of fluency in English
4. Received psychological treatment for a mental health or cannabis use problem in the previous month.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Half of the sample will be randomly allocated to a waitlist control group. These participants will act as a control for themselves (one month without the intervention vs one month with the intervention) and for the immediate-access group (effect of intervention vs. no intervention over a
one-month period).
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A priori power calculation was conducted to determine an adequate sample size for the website trial. The calculation was conducted assuming a small to medium effect size (0.2), a 0.05 statistical significance level and 80% power. The total sample size required was calculated to be 156 participants (n=156). Assuming a 20% attrition rate, a target of 180 participants was set to meet the number required for adequate power assuming attrition.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288453 0
Charities/Societies/Foundations
Name [1] 288453 0
Young and Well Cooperative Research Centre
Address [1] 288453 0
Unit 17, 71 Victoria Crescent
Abbotsford VIC 3067
AUSTRALIA
Country [1] 288453 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Young and Well Cooperative Research Centre
Address
Unit 17, 71 Victoria Crescent
Abbotsford VIC 3067
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 287156 0
None
Name [1] 287156 0
Address [1] 287156 0
Country [1] 287156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290370 0
QUT Human Research Ethics Committee
Ethics committee address [1] 290370 0
Queensland University of Technology Institute of Health and Biomedical Innovation (QUT IHBI)
60 Musk Ave
Kelvin Grove 4059
Qld
Ethics committee country [1] 290370 0
Australia
Date submitted for ethics approval [1] 290370 0
Approval date [1] 290370 0
04/11/2014
Ethics approval number [1] 290370 0

Summary
Brief summary
This study will evaluate the usability, acceptability and impact of the Keep It Real website for young cannabis users with psychotic-like experiences (PLEs).

Participants will be asked to evaluate a new website about cannabis use and psychotic-like experiences (PLEs). This evaluation will determine the impact of the 'Keep it Real' website on PLEs and cannabis use in young people.

180 participants will be given 6 months' access to the website. Half of these participants will comprise a waitlist control, whose access to the website will be delayed by one month. They will complete an online survey at 1, 2, 3, and 6 months' follow up. This will assess outcomes such as PLEs, cannabis use, psychological distress and functioning. Information will be collected about the number of times the website was used; the date, time and duration of each session; the sections of the website accessed and data entered.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45094 0
Dr Leanne Hides
Address 45094 0
QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059
Country 45094 0
Australia
Phone 45094 0
+617 3138 6144
Fax 45094 0
Email 45094 0
leanne.hides@qut.edu.au
Contact person for public queries
Name 45095 0
Dr Leanne Hides
Address 45095 0
QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059
Country 45095 0
Australia
Phone 45095 0
+617 3138 6144
Fax 45095 0
Email 45095 0
leanne.hides@qut.edu.au
Contact person for scientific queries
Name 45096 0
Dr Leanne Hides
Address 45096 0
QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059
Country 45096 0
Australia
Phone 45096 0
+617 3138 6144
Fax 45096 0
Email 45096 0
leanne.hides@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary