Recruiting

Mental Health Multimorbidity

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT07699159

Conditions

Multiple Mental Health Conditions

Child Mental Health

Youth Mental Health

Eligibility Criteria

Sex: All

Age: 11 - 24

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Multiple Mental Health Conditions

Child Mental Health

Youth Mental Health

Study ID

NCT07699159

Start date

Mar 4, 2025

Status verified date

Jun, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 24

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1620 participants

Anticipated

Interventions and Outcome Measures

Arms

MOT

In the MOT/Light Protocol, clinical, and functional measures will be collected in addition to blood-based 'omics' including proteomic (immune markers) and genomic analysis of DNA derived from blood and/or saliva. Over 3 years n=1620 children and youth will be recruited to the MOT/Light Protocol across the CALM Network.

A number of measures will be collected throughout the course of the study in order to capture symptoms across a spectrum of conditions in the target population. Provided that the main objective of the CALM project is to improve clinical care for youth with a particular focus on MMHC, it is vital to use validated standardized assessments that test highly prevalent physical and mental health conditions. MOT/Light measures will be collected via self-report (SR), rated-administered (RA), caregiver-administered (Ca), or a combination

Deep Phenotyping

Multidimensional, multilevel data will be obtained in a subcohort of CALM Study youth (3 years n=\~614) recruited to the MOT who also consent to participate in the Deep Phenotyping protocol. The Deep Phenotyping Protocol includes additional clinical, behavioural, developmental and functional outcomes, not collected as part of the light phenotyping battery as well as the collection of neurocognitive measures and neuroimaging data. Cognitive phenotyping will be administered at 0 and 6 month time points. Neuroimaging will be collected at one time point, harmonized across sites using human connectome quality scanning and to key external initiatives (e.g., neuroimaging via ABCD) facilitating secondary data use, and the utilization of additional cohorts in analysis.

Primary outcome measure

  • Diagnostic Assessment for the Health Spectrum [ Time Frame: Baseline and 24 months ]
  • Adolescent Health History [ Time Frame: Baseline, 12 months, 24 months ]
  • Assessment of Quality of Life [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months ]
  • Brain-CODE Demographic Form [ Time Frame: Baseline, 12 months, 24 months ]
  • Brain-CODE Medical History Form incorporating Developmental History Questionnaire (DHQ) Items [ Time Frame: Baseline, 12 months, 24 months ]
  • Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale [ Time Frame: Baseline, 12 months, 24 months ]
  • Child and Youth Resilience Measure [ Time Frame: Baseline, 12 months, 24 months, 36 months ]
  • The Columbia Suicide Severity Rating Scale [ Time Frame: Baseline, 24 months ]
  • Self-Injurious Thoughts and Behaviours Interview [ Time Frame: Baseline, 24 months ]
  • Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale [ Time Frame: Baseline, 12 months, 24 months ]
  • Difficulties in Emotion Regulation Scale Short Form [ Time Frame: Baseline, 12 months, 24 months, 36 months ]
  • Eating Disorder Examination Questionnaire (EDE-QS) Short Form [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months ]
  • General Anxiety Disorder-7 [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
  • General Behaviour Inventory-10 Mania [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
  • General Life Satisfaction [ Time Frame: Baseline, 18 months, 30 months ]
  • The Goal-Based Outcome (GBO) Tool [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months ]
  • Internalized Stigma of Mental Illness [ Time Frame: Baseline ]
  • International Sedentary Assessment Tool [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months ]
  • McMaster Family Functioning Scale [ Time Frame: Baseline, 12 months, 24 months, 36 months ]
  • Treatment Log [ Time Frame: Baseline, 6 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
  • Ohio State University Traumatic Brain Injury Identification Method [ Time Frame: 3 months, 30 months ]
  • Ontario Child Health Study Emotional Behavioural Scales - Brief [ Time Frame: Baseline, 6 months, 24 months ]
  • Patient Global Improvement Scale [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months ]
  • Patient Health Questionnaire [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
  • Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]
  • Phlebotomy (blood) collection [ Time Frame: Baseline, 12 months, 24 months ]
  • Physical Exam (Height, Weight, Body Mass Index, Waist Circumference, Neck Circumference, and Blood Pressure) [ Time Frame: Baseline, 12 months, 24 months, 36 months ]
  • PRIME- Revised [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 42 months ]
  • Revised Child Anxiety and Depression Scale [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
  • Saliva collection [ Time Frame: Baseline, 12 months, 24 months ]
  • The Short Warwick-Edinburgh Mental Well-being Scale [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months ]
  • The Social Communication Questionnaire [ Time Frame: Baseline ]
  • Social Responsiveness Scale (SRS) - Short Form [ Time Frame: Baseline, 12 months, 24 months, 30 months, 42 months ]
  • Strengths and Weaknesses of Attention-Deficit/Hyperactivity (SWAN) Disorder Symptoms and Normal Behavior scale [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]
  • Suicidal Ideation Questionnaire-Junior [ Time Frame: Baseline, 3 months, 12 months, 24 months, 30 months, 42 months ]
  • Toronto Obsessive-Compulsive Scale - Brief [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ]
  • Unmet Needs Questionnaire [ Time Frame: 12 months, 24 months, 36 months ]
  • Youth Life Interference Scale [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months ]
  • Kiddie Schedule for Affective Disorders and Schizophrenia [ Time Frame: Baseline, 24 months ]
  • Prodromal Questionnaire - Brief [ Time Frame: Baseline ]
  • Structured Interview for Prodromal Symptoms (SIPS) Negative/Disorganized Subscales [ Time Frame: Baseline ]
  • The Adolescent Alcohol and Drug Involvement Scale [ Time Frame: Baseline ]
  • Assessment of Educational Attainment [ Time Frame: Baseline ]
  • Social Responsiveness Scale - Long Form [ Time Frame: Baseline ]
  • Columbia Impairment Scale [ Time Frame: Baseline ]
  • Global Functioning: Social and Role Scales - Brief [ Time Frame: Baseline ]
  • Self-report World Health Organization - Disability Assessment Schedule [ Time Frame: Baseline ]
  • Health and Social Service Utilization measure [ Time Frame: 6 months ]
  • Transition Readiness Assessment Questionnaire [ Time Frame: 6 months ]
  • Internet Addiction Test [ Time Frame: Baseline ]
  • Parent Child Internet Addiction Test [ Time Frame: Baseline ]
  • Leisure Time Questionnaire [ Time Frame: Baseline, 6 months ]
  • MRI Scan [ Time Frame: Baseline ]
  • Edinburgh Handedness Inventory - Brief [ Time Frame: Baseline ]
  • The Snellen Chart [ Time Frame: Baseline ]
  • Toolbox Dimensional Change Card Sort Task [ Time Frame: Baseline ]
  • Toolbox Flanker Task [ Time Frame: Baseline ]
  • Toolbox List Sorting Working Memory Test [ Time Frame: Baseline ]
  • Toolbox Oral Reading Recognition Task [ Time Frame: Baseline ]
  • Toolbox Pattern Comparison Processing Speed Test [ Time Frame: Baseline ]
  • Toolbox Picture Sequence Memory Test [ Time Frame: Baseline ]
  • Toolbox Picture Vocabulary Task [ Time Frame: Baseline ]
  • Rey Auditory Verbal Learning Test [ Time Frame: Baseline ]
  • Wechsler Intelligence Test for Children-V Matrix Reasoning [ Time Frame: Baseline ]
  • Little Man Task [ Time Frame: Baseline ]
  • Delay Discounting Task [ Time Frame: 6 months ]
  • Emotional Stroop Task [ Time Frame: 6 months ]
  • Penn Emotion Differentiation Task [ Time Frame: 6 months ]
  • The Awareness of Social Inference Test (TASIT) - Short Version [ Time Frame: 6 months ]
  • Parental Bonding Instrument [ Time Frame: Baseline ]
  • Personality Inventory for DSM-5 Faceted Brief Form [ Time Frame: 6 months ]
  • Competitive Sports Questionnaire [ Time Frame: 6 months ]
  • International Physical Activity Questionnaire [ Time Frame: 6 months ]
  • Pain Questionnaire [ Time Frame: 6 months ]
  • Puberty Development Scale [ Time Frame: 6 months ]
  • Social Media Addiction Questionnaire [ Time Frame: Baseline ]
  • Acculturation Questionnaire [ Time Frame: 6 months ]
  • Mexican American Cultural Values Scale [ Time Frame: 6 months ]
  • Multigroup Ethnic Identity-Revised [ Time Frame: 6 months ]
  • Vancouver Index of Acculturation - Short [ Time Frame: 6 months ]
  • Parental Monitoring [ Time Frame: 6 months ]
  • Prosocial Scale from the Strengths and Difficulties Questionnaire [ Time Frame: 6 months ]
  • Conflict Behavior Questionnaire [ Time Frame: 6 months ]
  • Gender Dysphoria Questionnaire for Adolescents and Adult [ Time Frame: 6 months ]
  • Personal Attributes Questionnaire [ Time Frame: 6 months ]
  • Adverse Life Events Scale [ Time Frame: 6 months ]
  • Childhood Trauma Questionnaire - Short Form [ Time Frame: 6 months ]
  • Connor-Davidson Resilience Scale [ Time Frame: 6 months ]
  • Everyday Discrimination Scale [ Time Frame: 6 months ]
  • Life Events Checklist [ Time Frame: 6 months ]
  • Inventory for School Risk and Protective Factors [ Time Frame: 6 months ]
  • Neighbourhood Safety and Crime Scale [ Time Frame: 6 months ]
  • 3-Digit Postal Codes [ Time Frame: Baseline ]
  • Parent General Behaviour Inventory-10 Mania [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
  • Video Game Addiction Questionnaire [ Time Frame: Baseline ]
  • Student Adaptation to College Questionnaire [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Louise Gallagher, MD, PhD

416-535-8501louise.gallagher@camh.ca

Janani Selvachandran, PhD

437-441-2294janani.selvachandran@camh.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Paul Arnold, MD, PhD, FRCPC

403-210-6464paul.arnold@ucalgary.ca

Sadanee Pathiranawasam, MSc

647-515-6560sadanee.pathiranawas@ucalgary.ca

Principal Investigator:

Paul Arnold, MD, PhD, FRCPC

McMaster Children's Hospital, Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Melissa Kimber, BA, BSW, MSW, PhD

905-525-9140kimberms@mcmaster.ca

Alexe Bernier, PhD

403-542-5610bernia1@mcmaster.ca

Principal Investigator:

Melissa Kimber, BA, BSW, MSW, PhD

Children's Hospital of Eastern Ontario Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Gary Goldfield, PhD, C. Psych.

613-737-7600ggoldfield@cheo.on.ca

Karina Branje

613-737-7600kbranje@cheo.on.ca

Principal Investigator:

Gary Goldfield, PhD, C. Psych.

The Royal Ottawa Mental Health Centre

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Jennifer Phillips, PhD

613-722-6521jphillips@theroyal.ca

Aster Javier, MSc

613-722-6521ajavier@theroyal.ca

Principal Investigator:

Jennifer Phillips, PhD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Suneeta Monga, MD, FRCPC

416-813-7531suneeta.monga@sickkids.ca

Atushi Patel

437-212-3207atushi.patel@sickkids.ca

Centre for Addiction and Mental Health (CAMH)

Recruiting

Toronto, Ontario, Canada, M6J1H4

Contacts

Louise Gallagher, MD, PhD

416-535-8501louise.gallagher@camh.ca

Janani Selvachandran, PhD

437-441-2294janani.selvachandran@camh.ca

Principal Investigator:

Stephanie Ameis, MD, MSc, FRCPC

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Jul 13, 2026

Last verified

Jun, 2026

Keywords

  • multiple mental health conditions
  • child and youth mental health
  • mental health multimorbidity
  • master observational trial
  • deep phenotyping cohort

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-07-13.