RecruitingNCT07699159

Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions

Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM): A Master Observational Trial

Sponsor

Centre for Addiction and Mental Health

Enrollment

1,620 participants

Start Date

Mar 4, 2025

Study Type

OBSERVATIONAL

Conditions

Child Mental Health Multiple Mental Health Conditions Youth mental health

Summary

The Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM) Master Observational Trial is a prospective, longitudinal observational study that seeks to improve clinical care for youth with multiple mental health conditions (MMHC), also known as mental health multimorbidity in the literature. MMHC is conceptualized as the presence of two or more mental health diagnoses under the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). MMHC is common in youth seeking mental health services and is associated with less favorable outcomes and greater health services utilization. Mental health disorders also accumulate in youth over time. The Master Observational Trial (MOT) will investigate MMHC in critical developmental periods in youth and identify risk and protective factors that will provide a mechanistic understanding of how MMHC develops over time. A subset of participants will also enroll in a Deep Phenotyping Cohort, which includes enhanced clinical and cognitive assessments and multimodal neuroimaging to investigate neurobiological mechanisms underlying MMHC and identify potential biomarkers of illness complexity and progression. In the near future, we aim to add to the current protocol to embed both a clinical trials network for youth mental health in Ontario and Calgary within the CALM study and add digital phenotyping using wearable technology to generate digital and physiological markers of MMHC. The current protocol focuses on establishing the longitudinal MOT cohort and Deep Phenotype Cohort only as a ﬁrst step towards these long term CALM goals.

Eligibility

Min Age: 11 YearsMax Age: 24 Years

Inclusion Criteria6

Light Phenotype Eligibility Must sign and date the informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent; Aged 11-24 years old at the time of screening; Any person within age criteria who has previously sought, is seeking, or is accessing mental health services; Are able to complete assessments in English.
Deep Phenotype Eligibility Must be part of the CALM light phenotype cohort; Must sign and date the deep phenotyping informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent.
Light Phenotype Caregiver Participant Eligibility:
Any caregiver of a CALM child/youth participant is eligible to participate in the study, insofar as the child/youth participant has consented to the light phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.
Deep Phenotype Caregiver Participant Eligibility:
Any caregiver of a CALM child/youth participant is eligible to participate in the study, insofar as the child/youth participant has consented to the deep phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.

Exclusion Criteria8

An individual who meets any of the following criteria will be excluded from participation in this research study:
Light Phenotype Does not provide informed consent (for those with the capacity to consent) or assent (for those who lack the capacity to consent); For those individuals who lack the capacity to consent, the inability of the parent/legal guardian to provide informed consent for the youth is also an exclusion criterion; Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.
Light Phenotype Caregiver Participant Ineligibility:
Caregivers of CALM child/youth participants are ineligible to participate in the study if:
The child/youth participant does not agree for their caregiver to be contacted to participate in the study; The child/youth participant is not participating in the light phenotype cohort; Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.
Deep Phenotype Caregiver Participant Ineligibility:
Caregivers of CALM child/youth participants are ineligible to participate in the study if:
The child/youth participant does not agree for their caregiver to be contacted to participate in the study; The child/youth participant is not participating in the deep phenotype cohort (i.e., is only participating in the light phenotyping cohort); Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.