Youth Master Observational Study of Multiple Mental Health Conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CALM MOT is a prospective, longitudinal observational program that enrolls children and youth with multiple mental health conditions to characterize progression and outcomes. A subset enters a Deep Phenotyping Cohort, which collects in-depth cognitive testing and multimodal brain imaging to explore brain-based mechanisms and potential biomarkers. The study aims to support the development of transdiagnostic interventions and a research network for MMHC. Investigators will use data from multiple sites in Canada to understand risk and protective factors during critical developmental periods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The participant must meet all of the inclusion criteria to be eligible for this research study:

* 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 Criteria:

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.

Deep Phenotype Unable to participate in deep phenotyping protocol (e.g., MRI contraindication, uncorrected vision or hearing impairments that would interfere with data collection, unwillingness to complete assessments); No exclusion criteria are based on race, ethnicity, sex or gender.

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.

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• McMaster Children's Hospital, Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting
• Children's Hospital of Eastern Ontario Research Institute
  Ottawa, Ontario, Canada Recruiting
• The Royal Ottawa Mental Health Centre
  Ottawa, Ontario, Canada Recruiting
• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting
• Centre for Addiction and Mental Health (CAMH)
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Louise Gallagher, MB, BCh, PhD — Centre for Addiction and Mental Health
• Study coordinator: Louise Gallagher, MD, PhD
• Email: louise.gallagher@camh.ca
• Phone: 416-535-8501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.