Recruiting

Genetic Counselling

Sponsor:

Nova Scotia Health Authority

Code:

NCT03601026

Conditions

Mental Illness

Schizophrenia

Bipolar Disorder

Major Depressive Disorder

Cannabis Use

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Interventions

Genetic counselling

Study Details

Brief summary:

Severe mental illness (SMI) refers to the most burdensome psychiatric conditions. The need to pre-empt the onset of SMI is pressing because once SMI develops, quality of life is poor and available treatments have limited efficacy. Most risk factors for SMI are either unchangeable (e.g., genetics) or difficult to alter (e.g., low socio-economic status). In contrast, cannabis use is one specific risk factor that could be avoided. Certain individuals are more vulnerable to the harmful effects of cannabis. Genetic factors can help us identify these high-risk individuals. One in three individuals are carriers of a higher-risk genetic variant, and cannabis users with this genotype are at up to 7-fold increased risk of developing schizophrenia. In our study, genetic counselling will be provided to participants by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype. 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 the participants accept the genetic test results). The investigators hypothesize that this intervention will reduce exposure to cannabis compared to the youth who are not offered the intervention.

Conditions

Mental Illness

Schizophrenia

Bipolar Disorder

Major Depressive Disorder

Cannabis Use

Study ID

NCT03601026

Start date

Nov 1, 2019

Status verified date

May, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Enrolment in the Families Overcoming Risks and Building Opportunities for Well-being (FORBOW) study.
  • Age between 12 and 21 years.
  • Knowledge of English sufficient to benefit from the intervention.
  • Capacity to provide informed consent at most recent FORBOW assessment.
  • Provision of consent to be contacted about future studies at most recent FORBOW assessment.

Exclusion Criteria:

  • A diagnosis of severe mental illness (psychotic disorder, bipolar disorder, severe/recurrent depression) at baseline
  • Autism or intellectual disability of a degree that interferes with assessment (IQ < 70)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Genetic counselling

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.

no intervention: Control group

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.

Interventions

Genetic counselling

Participants will receive information on risk/protective factors and causes of mental illness. Participants are not required to receive numeric/genetic risk information. Participants who choose to receive genetic and/or numeric risk information will be counselled on their risk of NOT developing and of developing SMI based on their genetic test results and/or family history information they provide. Risk estimates will be derived by genetic counsellors, according to standard practice guidelines. Participants who receive genetic information will be counselled on the possible influence of cannabis use on risk of mental illness based on their genotype. Participants who choose to not receive genetic information will be counselled on the influence of cannabis on mental health.

Primary outcome measure

  • Self-reported cannabis use [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Rudolf Uher, MD, PhD

902-473-7209uher@dal.ca

Locations

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E2

Contacts

Rudolf Uher, MD PhD

uher@dal.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

May 14, 2025

Last verified

May, 2025

Keywords

  • Severe mental illness
  • Developmental psychopathology
  • Trial-within-cohort
  • Genetic counselling
  • Cannabis use
  • Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-05-14.