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Behavioral Intervention
Genetic Counseling for Mental Health Risks Associated with Cannabis Use (IMAGINE Trial)
N/A
Recruiting
Led By Rudolf Uher, MD, PhD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capacity to provide informed consent at most recent FORBOW assessment.
Age between 12 and 21 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of study (2 years).
Awards & highlights
IMAGINE Trial Summary
This trialwill look at how genetic counselling can reduce cannabis use & lower risk of severe mental illness.
Who is the study for?
This trial is for English-speaking individuals aged 12-21 who are part of the FORBOW study, can consent to future contact, and have the capacity to give informed consent. It excludes those with severe mental illness, autism, or intellectual disability (IQ < 70).Check my eligibility
What is being tested?
The trial tests if genetic counselling can help young people understand their personal risk of developing severe mental illness due to cannabis use. Participants may learn about their own genetic predisposition towards such risks.See study design
What are the potential side effects?
Genetic counselling is a discussion-based intervention and typically does not involve physical side effects. However, learning about one's genetic risks could potentially cause anxiety or emotional distress.
IMAGINE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was able to understand and agree to the study's requirements recently.
Select...
I am between 12 and 21 years old.
IMAGINE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of study (2 years).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of study (2 years).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-reported cannabis use
Secondary outcome measures
Presence of cannabinoids in urine
The proportion of participants who complete the intervention after receiving an offer to participate (intervention acceptability)
IMAGINE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Genetic counsellingExperimental Treatment1 Intervention
Eligible participants who are randomized will be contacted and offered an invitation to attend the intervention. Genetic counselling will be provided to participants who accept the intervention as a single 1-2 hour session by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype at rs2494732. Participants will be counselled regarding their individualized risk of developing and of NOT developing SMI based on family history, whether or not they choose to use cannabis, and genotype (if they accept the genetic test results). Approximately 1 month after the intervention, participants will receive a follow-up interview.
Group II: Control groupActive Control1 Intervention
Eligible participants who are not randomized to be offered the intervention will continue with their annual assessments as part of the parent study. These participants will receive the current standard of care (no intervention), and will not be offered or informed of the intervention.
Find a Location
Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
258 Previous Clinical Trials
83,734 Total Patients Enrolled
1 Trials studying Psychosis
22 Patients Enrolled for Psychosis
Rudolf Uher, MD, PhDPrincipal InvestigatorNova Scotia Health Authority, Dalhousie University
4 Previous Clinical Trials
30,764 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was able to understand and agree to the study's requirements recently.Your intellectual disability is severe enough that it affects your ability to be assessed (IQ score below 70).I am between 12 and 21 years old.I have been diagnosed with a severe mental illness.
Research Study Groups:
This trial has the following groups:- Group 1: Genetic counselling
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What type of individual makes for an ideal candidate in this clinical experiment?
"To be accepted into this research program, those with schizophrenia and in the age group of 12 to 21 are eligible. A total of 120 individuals will be involved in the trial."
Answered by AI
Is this research initiative open to people above the age of sixty?
"This trial is open to applicants aged 12-21. The clinicaltrials database shows there are 436 trials for youths under 18 and 1442 studies targeting elderly individuals over 65 years old."
Answered by AI
Are people currently being enrolled for this experiment?
"According to clinicaltrials.gov, this study is no longer recruiting patients as it was last updated on July 22nd 2019 and originally posted on August 1st 2019. However, there are currently 2,219 other medical trials searching for participants."
Answered by AI
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