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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12615000455561
Date of registration: 11/05/2015
Prospective Registration: No
Primary sponsor: Young and Well Cooperative Research Centre
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?
Date of first enrolment: 05/05/2015
Target sample size: 230
Recruitment status: Active, not recruiting
URL:  https://anzctr.org.au/ACTRN12615000455561.aspx
Study type:  Interventional
Study design:  Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Other;  
Phase:  Not Applicable
Countries of recruitment
Australia
Contacts
Name: Dr Leanne Hides   
Address:  QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059 Australia
Telephone: +617 3138 6144
Email: leanne.hides@qut.edu.au
Affiliation: 
Name: Dr Leanne Hides   
Address:  QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059 Australia
Telephone: +617 3138 6144
Email: leanne.hides@qut.edu.au
Affiliation: 
Key inclusion & exclusion criteria
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

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.


Age minimum: 16 Years
Age maximum: 25 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Mental Health - Addiction
Cannabis use with psychotic-like experiences amongst young people;
Cannabis use with psychotic-like experiences amongst young people
Mental Health - Psychosis and personality disorders
Intervention(s)
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.
Primary Outcome(s)
Number of PLEs experienced. PLEs will be assessed via the Community Assessment of Psychic Experience Questionnaire (CAPE); 3 month version. [3 months CAPE will be administered at Baseline (Treatment group), 1 month (delayed group); 3 months and 6 months (both groups). ]
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’.[Baseline; 1, 2, 3 and 6 months post.]
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.[Baseline;1, 3 and 6 months post.]
Secondary Outcome(s)
Functioning. This will be assessed via the Assessment of Quality of Life Questionnaire (AQOL-6D). [Baseline and 3 months]
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).[Baseline; 1, 2, 3 and 6 months post.]
Secondary ID(s)
Nil
Source(s) of Monetary Support
Young and Well Cooperative Research Centre
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
QUT Human Research Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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