Main
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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:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12615000455561 |
Date of registration:
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11/05/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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?
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Scientific title:
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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:
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05/05/2015 |
Target sample size:
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230 |
Recruitment status: |
Active, not recruiting |
URL:
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https://anzctr.org.au/ACTRN12615000455561.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Other;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Leanne Hides
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Address:
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QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059
Australia |
Telephone:
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+617 3138 6144 |
Email:
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leanne.hides@qut.edu.au |
Affiliation:
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Name:
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Dr Leanne Hides
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Address:
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QUT IHBI 60 Musk Ave Kelvin Grove QLD 4059
Australia |
Telephone:
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+617 3138 6144 |
Email:
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leanne.hides@qut.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Mental Health - Addiction
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Cannabis use with psychotic-like experiences amongst young people; Cannabis use with psychotic-like experiences amongst young people
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Mental Health - Psychosis and personality disorders
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Intervention(s)
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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.
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Primary Outcome(s)
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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). ]
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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.]
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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.]
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Secondary Outcome(s)
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Functioning. This will be assessed via the Assessment of Quality of Life Questionnaire (AQOL-6D). [Baseline and 3 months]
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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.]
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Source(s) of Monetary Support
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Young and Well Cooperative Research Centre
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Ethics review
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Status: Approved
Approval date:
Contact:
QUT Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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