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NCT Number: NCT07699159

Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions

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.

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Key information

Age range

11 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

The primary objectives of the CALM MOT are to:

  • Establish a prospective, longitudinal cohort of children and youth aged 11-24 years to characterize the progression and outcomes of MMHC over time.
  • Facilitate later development of a clinical trials network and clinical research in MMHC with a focus on developing transdiagnostic interventions and improving care.
  • Establish a deeply phenotyped cohort of youth in a subset of participants enrolled in the MOT (light phenotyping protocol), using multidimensional, multilevel data to investigate brain-based mechanisms of MMHC with potential for biomarker discovery.

Specific objectives of the Deep Phenotyping Cohort are to:

  • Collect data across CALM sites in participants that are eligible and consent to participate in CALM MOT Light and the Deep Phenotyping Protocol. In this subset of CALM participants, we will extend the clinical/behavioural measurement battery, and collect high quality cognitive and multimodal (T1, multi-shell DWI, resting state, ASL) neuroimaging data that will be undertaken as part of the CALM baseline deep phenotyping protocol.
  • Use open access brain age and centile score calculators using unimodal brain imaging data to examine centile score distributions for various data samples in a sex stratified manner (e.g., clinical/community ascertained) and associations between centile scores with behavioral/cognitive indices of clinical severity/impairment and MMHC (e.g., MMHC index). Available open access normative and clinically enriched neuroimaging samples that overlap with the proposed CALM sample age range (11-24 years) will be utilized.
  • Undertake analysis using cross-sectional neuroimaging and longitudinal MOT data derived from the CALM network to test whether deviations from normative brain measures using either unimodal or integrating data from different imaging sequences (i.e., multimodal), imaging calculators may have utility as a baseline 'prognostic/predictive' marker of youth who may have more complex illness (i.e., MMHC) at the time of initial (baseline) participation in the CALM study and at subsequent time points and/or may be less responsive to clinical interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnostic Assessment for the Health Spectrum

    Time frame: Baseline and 24 months

    The Diagnostic Assessment for the Health Spectrum (DASH) is a semi-structured screener and interview that evaluates a broad range of psychiatric symptoms and associated symptoms. It also assesses a number of physical health symptoms. The DASH is based on the core structure of the Schedule for Affective Disorders and Schizophrenia-SADS and Kiddie-SADS, and includes features of a number of other structured interviews of psychopathology. It provides a diagnostic spectrum in addition to categorical diagnoses that are aligned to the DSM-IV and DSM-5. The completed interview yields a narrative report and summary for clinicians and researchers. There are three versions (adult, child, and parent on child) which take approximately 90-240+ minutes to complete.

  2. Adolescent Health History

    Time frame: Baseline, 12 months, 24 months

    Youth and caregivers will be asked to self-report the presence of health conditions using the Adolescent Health History measure to indicate whether the youth has in the past or currently has any of over 40 common mental or physical health conditions listed. Youth will also be able to add up to four other conditions not listed.

  3. Assessment of Quality of Life

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

    The Assessment of Quality of Life (AQoL) measures 5 dimensions: illness, independent living, social relationships, physical senses and psychological well being. Each dimension is measured by three items (a total of 15 items).

    Total scores can range from a minimum of 20 to a maximum of 99, with higher scores indicating poorer quality of life.

  4. Brain-CODE Demographic Form

    Time frame: Baseline, 12 months, 24 months

    The Brain-CODE Demographic Form is a standard form developed by Brain-CODE to capture demographic information from participants.

  5. Brain-CODE Medical History Form incorporating Developmental History Questionnaire (DHQ) Items

    Time frame: Baseline, 12 months, 24 months

    The Brain-CODE Medical History Form is a standard form developed by Brain-CODE to capture medical history in participants.

  6. Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale

    Time frame: Baseline, 12 months, 24 months

    The Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale includes 10 items assessing youth's self-reported exposure to different forms of maltreatment by their caregivers, including physical, sexual and emotional abuse, neglect, as well as exposure to violence between caregivers. One additional item captures youth's exposure to corporal punishment. Items have been administered in population-based studies that include samples of youth and adults, as well as clinical observational studies and trials. Total scores can range from a minimum of 10 to a maximum of 50, with higher scores indicating more negative experiences.

  7. Child and Youth Resilience Measure

    Time frame: Baseline, 12 months, 24 months, 36 months

    The Child and Youth Resilience Measure is a screening tool to explore the resources (individual, relational, communal and cultural) available to individuals that may bolster their resilience. Individuals aged 24+ will be asked to complete the Adult Resilience Measure. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.

  8. The Columbia Suicide Severity Rating Scale

    Time frame: Baseline, 24 months

    The Columbia Suicide Severity Rating Scale is a validated and widely used rater-administered measure of suicidal ideation and behaviour, and non-suicidal self-injury. It will be administered to all participants. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.

  9. Self-Injurious Thoughts and Behaviours Interview

    Time frame: Baseline, 24 months

    The Self-Injurious Thoughts and Behaviours Interview (SITBI) measures self-injurious thoughts and behaviors.

  10. Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale

    Time frame: Baseline, 12 months, 24 months

    The Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale includes 10 items and is designed to assess youth exposure to bullying in the preceding 12 months. Items capture both the type and frequency of bullying, with types of bullying covered by the measure including verbal, physical, relational, and online forms of bullying. Response options are captured on an ordinal scale encompassing: Never, A few Times a Year, Monthly, Weekly, Daily. Total scores can range from a minimum of 10 to a maximum of 50, with higher scores indicating more experiences with bullying.

  11. Difficulties in Emotion Regulation Scale Short Form

    Time frame: Baseline, 12 months, 24 months, 36 months

    The Difficulties in Emotion Regulation Scale Short Form is an 18-item measure used to identify emotional regulation issues. The measure covers 4 dimensions of emotional regulation: awareness and understanding of emotions; acceptance of emotions; the ability to engage in goal-directed behavior and refrain from impulsive behavior when experiencing negative emotions; and access to emotion regulation strategies perceived as effective. Total scores can range from a minimum of 18 to a maximum of 90, with higher scores indicating more difficulties with emotion regulation.

  12. Eating Disorder Examination Questionnaire (EDE-QS) Short Form

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

    The Eating Disorder Examination Questionnaire (EDE-QS) Short Form is a 12-item, self-report questionnaire capturing eating disorder symptoms. Response options are anchored on a 4-point ordinal response scale that captures symptoms over the preceding 7 days. Total scores can range from a minimum of 0 to a maximum of 36, with higher scores indicating the presence of more eating disorder symptoms.

  13. General Anxiety Disorder-7

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

    The General Anxiety Disorder-7 (GAD-7) measures presence and severity of Generalized Anxiety Disorder. Total scores can range from a minimum of 0 to a maximum of 21, with higher scores indicating greater presence and severity of anxiety symptoms.

  14. General Behaviour Inventory-10 Mania

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

    The General Behaviour Inventory-10 Mania measures the presence and severity of mania. Total scores can range from a minimum of 0 to a maximum of 30, with higher scores indicating greater presence and severity of mania.

  15. General Life Satisfaction

    Time frame: Baseline, 18 months, 30 months

    A singular question from the Canadian Social Survey - Quality of Life and Energy Consumption Behaviours measure will be administered to determine life satisfaction. Total scores can range from a minimum of 0 to a maximum of 10, with higher scores indicating greater life satisfaction.

  16. The Goal-Based Outcome (GBO) Tool

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

    The Goal-Based Outcome (GBO) Tool aims to measure the progress and outcomes of an intervention in a simple way. It can be applied in any setting and is currently available in 9 languages. The child GBO tool contains a record sheet whereby up to 3 goals with their descriptions can be written down, followed by a goal rating sheet with descriptions and a scale ranging from 0 (Goals not at all met) to 10 (Goal reached). A goal progress chart at the end can be used to rate the progress of the goal across 12 sessions.

  17. Internalized Stigma of Mental Illness

    Time frame: Baseline

    The Internalized Stigma of Mental Illness (ISMI) scale is a questionnaire measuring self-stigma among persons with psychiatric disorders. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.

  18. International Sedentary Assessment Tool

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

    This measure consists of two parts. The first part has six items, and asks questions based on typical weekday activity in the last week. The second part also includes six items and asks questions pertaining to typical weekend activities within the last week. Higher scores equate to more sedentary behaviors in a participant.

  19. McMaster Family Functioning Scale

    Time frame: Baseline, 12 months, 24 months, 36 months

    The McMaster Family Functioning Scale is a shorter 12-item assessment developed from The McMaster Family Assessment Device, which is a 60-item questionnaire that measures an individual's perceptions of their family. Total scores can range from a minimum of 12 to a maximum of 48, with higher scores indicating more positive perceptions of family.

  20. Treatment Log

    Time frame: Baseline, 6 months, 18 months, 24 months, 30 months, 36 months, 42 months

    This inventory records prescribed treatment and medication, adherence and tolerability every 6 months.

  21. Ohio State University Traumatic Brain Injury Identification Method

    Time frame: 3 months, 30 months

    The Ohio State University Traumatic Brain Injury Identification Method measures a participant's history of traumatic brain injury. Baseline and follow-up versions will be administered.

  22. Ontario Child Health Study Emotional Behavioural Scales - Brief

    Time frame: Baseline, 6 months, 24 months

    The Ontario Child Health Study Emotional Behavioural Scales - Brief (OCHS-EBS-B) is a 25-item measurement tool for participants under the age of 18 that assesses common child/youth mental health disorders within the last 6 months. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.

  23. Patient Global Improvement Scale

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

    The Patient Global Improvement Scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Scores range from 0 to 7, with lower scores reflecting more positive symptoms and thus improvement in clinical status.

  24. Patient Health Questionnaire

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

    The Patient Health Questionnaire (PHQ) is a self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day).

  25. Pittsburgh Sleep Quality Index

    Time frame: Baseline

    This assessment is designed to evaluate the overall sleep quality in a clinical population. It is a 19-item self-reported questionnaire assessing seven subcategories; use of sleeping medication, subjective sleep quality, sleep latency, duration, sleep efficiency, disturbances and dysfunction during the daytime. Each subcategory ranges from scores of 0 to 3, with higher scores reflecting poorer sleep patterns.

  26. Phlebotomy (blood) collection

    Time frame: Baseline, 12 months, 24 months

    Blood will be collected by a trained phlebotomist or research nurse with experience working with children and youth. Blood will be collected at baseline, and then annually. A maximum of 40 mL of blood will be collected per participant; however, sites may collect reduced volumes due to site-specific procedures and/or participant limitations. To ensure sufficient sample volumes for clinical and genetic/immune analyses, a minimum collection threshold will be applied to each.

    Clinical testing (7-20 mL): Samples will be transferred to clinical labs for CBC, differential white cell count, HbA1C, CRP, glucose, and lipid testing.

    Genetic and immune analysis (16-20 mL): Samples will be analyzed for genetic, epigenetic, and immune markers.

    Sites will aim to collect the full 20 mL for both clinical and genetic testing whenever possible.

  27. Physical Exam (Height, Weight, Body Mass Index, Waist Circumference, Neck Circumference, and Blood Pressure)

    Time frame: Baseline, 12 months, 24 months, 36 months

    A physical exam will be completed by trained research or clinical staff during the clinic visit. If the participant is unable to attend the clinic visit, research staff will use recent values from their medical record or provide instructions to the participant for measuring their height, weight, waist circumference and neck circumference at home (blood pressure will not be measured at home).

  28. PRIME- Revised

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 42 months

    This is a self-administered questionnaire that is designed to assess individuals at risk for developing a psychotic disorder. It contains 12 items that assess positive symptoms on a distress scale ranging from 0 (Definitely disagree) to 6 (Definitely agree).

  29. 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

    The Revised Child Anxiety and Depression Scale (RCADS-25) is a self-report questionnaire that assesses symptoms of depression and anxiety in children and adolescents. This assessment captures symptoms related to generalized anxiety disorder (GAD), major depressive disorder (MDD), panic disorder, social phobia, separation anxiety disorder (SAD), and obsessive-compulsive disorder (OCD).

  30. Saliva collection

    Time frame: Baseline, 12 months, 24 months

    Participants will be asked to provide a saliva sample to be used for genetic and epigenetic analyses. A saliva collection kit, such as that made by Oragene, will be used. Approximately 1.5 mL of saliva is provided when someone 'spits' into the collection tube. Cheek cells in saliva contain the DNA that will ultimately be extracted and processed.

  31. The Short Warwick-Edinburgh Mental Well-being Scale

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

    The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) uses seven statements about thoughts and feelings to monitor mental wellbeing. The seven statements are positively worded with five response categories from 'none of the time' to 'all of the time'. Children and young people are asked to describe their experiences over the past two weeks.

  32. The Social Communication Questionnaire

    Time frame: Baseline

    The Social Communication Questionnaire (40-item parent questionnaire), which is based on the Autism Diagnostic Interview-Revised, will be used to measure current and developmental social communication deficits. This parent-report questionnaire provides information regarding social communication and repetitive behaviours present currently and from early childhood. Total scores can range from a minimum of 0 to a maximum of 39, with higher scores indicating stronger social communication.

  33. Social Responsiveness Scale (SRS) - Short Form

    Time frame: Baseline, 12 months, 24 months, 30 months, 42 months

    The Social Responsiveness Scale measures the severity of autism symptoms in a quantitative manner, both among children affected by symptoms that fall under the spectrum of autism as well as among children in the general population. Caregivers will complete the caregiver report school short form. Total scores can range from a minimum of 16 to a maximum of 64, with higher scores indicating lower social responsiveness.

  34. 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

    The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior scale assesses ADHD symptoms in the clinical and non-clinical population. It includes a set of 18 questions and a child's behavior is scored on a 7-point scale with 4 (average) reflecting a normal behavior for the child's age. The first 9 items are associated with inattentive ADHD and the next 9 items are associated with hyperactive/impulsive ADHD.

  35. Suicidal Ideation Questionnaire-Junior

    Time frame: Baseline, 3 months, 12 months, 24 months, 30 months, 42 months

    The Suicidal Ideation Questionnaire-Junior (SIQ-JR) consists of 15 items and will be completed by all youth in this study. It is designed for students in Grades 7-9. This assessment assists in informing adults/professionals of their levels of distress and suicidal intent without self-injurious behaviour. The overall aim of this measure is to assess suicidal ideation and risk.

  36. Toronto Obsessive-Compulsive Scale - Brief

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

    The Toronto Obsessive-Compulsive Scale (TOCS) is a 21-item parent or self-report questionnaire that assesses symptoms pertaining to Obsessive-Compulsive traits among children or adolescents. Total scores can range from a minimum of -72 to a maximum of 72, with higher scores indicating the presence of more Obsessive-Compulsive traits.

  37. Unmet Needs Questionnaire

    Time frame: 12 months, 24 months, 36 months

    The Unmet Needs Questionnaire measures the services participants are receiving and whether their needs are being met.

  38. Youth Life Interference Scale

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

    The Youth Life Interference Scale (YLIS) is an 11-item self-report measure assessing the impact of mental health symptoms on day-to-day functioning in the past two weeks. The measure was developed in-house for the TAY study. Its focus lies on functional impairment related to anxiety and depression for youth. Total scores can range from a minimum of 0 to a maximum of 36, with higher scores indicating greater functional impairment.

  39. Kiddie Schedule for Affective Disorders and Schizophrenia

    Time frame: Baseline, 24 months

    The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a widely used structured diagnostic interview that will be administered to participants in order to determine the presence of categorical mental health diagnoses. The K-SADS will be used for participants less than 18 years of age.

  40. Prodromal Questionnaire - Brief

    Time frame: Baseline

    This is a self-report screening measure for psychosis risk syndromes. It records psychosis-like symptoms that would have occurred over the past month. For each item in the questionnaire that is endorsed, responses range in levels of distress or impairment from a scale of 1 (strongly disagree) to 5 (strongly agree).

  41. Structured Interview for Prodromal Symptoms (SIPS) Negative/Disorganized Subscales

    Time frame: Baseline

    The Structured Interview for Prodromal Symptoms Negative/Disorganized Subscales is a diagnostic semi-structured interview used to assess the severity of symptoms and diagnose prodromal syndromes.

  42. The Adolescent Alcohol and Drug Involvement Scale

    Time frame: Baseline

    The Adolescent Alcohol and Drug Involvement Scale (AADIS) Revised is a self-report measure of adolescent problematic substance abuse, and will be used to quantify frequency of past-year substance use (including cannabis use). This scale also provides a numerical score derived from items related to behaviors associated with problematic use. Total scores can range from a minimum of 0 to a maximum of 84, with higher scores indicating more frequent use of substances.

  43. Assessment of Educational Attainment

    Time frame: Baseline

    Participants will be asked to fill in a self-report questionnaire measuring educational attainment which takes about 5 minutes to complete. The revised Educational Attainment Questionnaire will assess level of education, grades and accommodations or other support at school among other education-related items. Participants fill in the Educational Attainment Questionnaire at baseline. The Educational Attainment Questionnaire is composed of several items from the School Mental Health Survey that is part of the Ontario Child Health Study, a longstanding prospective study on the overall health of children in Ontario.

  44. Social Responsiveness Scale - Long Form

    Time frame: Baseline

    Autism spectrum symptoms will be evaluated using the long form of the Social Responsiveness Scale (SRS-2), which is a validated brief measure of autism traits consisting of 65 items. Caregivers will complete the caregiver report school version. Total scores can range from a minimum of 65 to a maximum of 260, with higher scores indicating the presence of more autism traits.

  45. Columbia Impairment Scale

    Time frame: Baseline

    The Columbia Impairment Scale (CIS) is a 13-item self and caregiver report scale which provides a global measure of impairment in 4 major areas of functioning: interpersonal relations (family and friends), broad psychopathological domains, job or school functioning, and use of leisure time. Total scores can range from a minimum of 0 to a maximum of 52, with higher scores indicating more global impairment.

  46. Global Functioning: Social and Role Scales - Brief

    Time frame: Baseline

    The Global Functioning: Social and Role Scales assessment measures social and role functioning through a semi-structured interview. Total scores can range from a minimum of 1 to a maximum of 10, with higher scores indicating greater functioning.

  47. Self-report World Health Organization - Disability Assessment Schedule

    Time frame: Baseline

    The Self-report World Health Organization - Disability Assessment Schedule is a 12-item generic assessment instrument for health and disability. This tool produces standardized disability levels and profiles directly linked at the level of the concepts to the International Classification of Functioning, Disability and Health (ICF), and covers six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. Total scores can range from a minimum of 0 to a maximum of 48, with higher scores indicating lower functioning.

  48. Health and Social Service Utilization measure

    Time frame: 6 months

    Youth will be asked to self-report their mental health and other health and social service utilization using an adapted version of the Health and Social Service Utilization measure that has been previously used with this population, including in the current Longitudinal Youth in Transition Study at the Centre for Addiction and Mental Health (CAMH). Additional items are adapted from the Ontario Student Drug Use and Health Survey.

  49. Transition Readiness Assessment Questionnaire

    Time frame: 6 months

    The Transition Readiness Assessment Questionnaire (TRAQ) will be used to assess the transition readiness of youth between the ages of 15 and 19 from youth to adult mental health services. Total scores can range from a minimum of 20 to a maximum of 100, with higher scores indicating greater transition readiness.

  50. Internet Addiction Test

    Time frame: Baseline

    The Internet Addiction Test measures the presence and severity of problematic internet use across six addictive domains: Conflict, Mood Modification, Salience, Tolerance, Relapse, and Withdrawal.

  51. Parent Child Internet Addiction Test

    Time frame: Baseline

    The Parent Child Internet Addiction Test measures the presence and severity of problematic internet use. This test is a 20-item measure asking the parent to indicate the frequency of behaviours in the child on a 6-point scale ranging from 'Does not apply' to 'Always'.

  52. Leisure Time Questionnaire

    Time frame: Baseline, 6 months

    The Leisure Time Questionnaire is used to assess time spent in leisure activities.

  53. MRI Scan

    Time frame: Baseline

    Youth participants enrolled in the deep phenotyping cohort will be asked to complete an MRI scan at their participating site for approximately 1 hour. Each scan will consist of high-quality T1-weighted, diffusion MRI (dMRI) and r-fMRI sequences that will be combined into a single neuroimaging output per participant.

  54. Edinburgh Handedness Inventory - Brief

    Time frame: Baseline

    The Edinburgh Handedness Inventory (EHI) - Brief is a four-item questionnaire used to assess laterality. Youth are asked to report the dominance of the right or left hand in everyday activities. Scores range from -100 (indicating left preference) to 100 (indicating right preference).

  55. The Snellen Chart

    Time frame: Baseline

    The Snellen Chart is an eye chart commonly used to assess visual acuity using eleven lines of block letters. Participants are asked to stand ten feet from the chart and to read the letters of each row aloud, beginning from the top row.

  56. Toolbox Dimensional Change Card Sort Task

    Time frame: Baseline

    The Toolbox Dimensional Change Card Sort Task assesses cognitive flexibility. Youth are presented with two stimuli at the bottom of the screen and asked to sort a third stimulus presented in the middle of the screen to match one of the two stimuli at the bottom, by either colour or shape.

  57. Toolbox Flanker Task

    Time frame: Baseline

    The Toolbox Flanker Task assesses attention and inhibitory control. Youth are presented with a target stimulus and two surrounding flanker stimuli, and are asked to indicate which direction the middle stimulus is facing (left or right); surrounding flanker stimuli may be facing in the same direction (congruent trials) or the opposite direction (incongruent trials).

  58. Toolbox List Sorting Working Memory Test

    Time frame: Baseline

    The Toolbox List Sorting Working Memory Test assesses working memory sequencing skills. Youth are presented with animals and foods of assorted sizes both visually and auditorily, and asked to list the items presented from smallest to largest. This test is repeated using items from a single category, and items from two categories; in the latter, youth are requested to list items from one category and then the other.

  59. Toolbox Oral Reading Recognition Task

    Time frame: Baseline

    The Toolbox Oral Reading Recognition Task assesses language exposure and reading skills. Youth are asked to pronounce visually presented letters or words.

  60. Toolbox Pattern Comparison Processing Speed Test

    Time frame: Baseline

    The Toolbox Pattern Comparison Processing Speed Test assesses visual processing. Youth are asked to determine whether two visually presented pictures are the same.

  61. Toolbox Picture Sequence Memory Test

    Time frame: Baseline

    The Toolbox Picture Sequence Memory Test assesses episodic memory. Youth are presented with 15 pictures demonstrating events and are asked to model those events as a series of actions using props.

  62. Toolbox Picture Vocabulary Task

    Time frame: Baseline

    The Toolbox Picture Vocabulary Task assesses language and verbal intellect. Participants are auditorily presented with a word and asked to choose which of four visually presented pictures matches that word.

  63. Rey Auditory Verbal Learning Test

    Time frame: Baseline

    The Rey Auditory Verbal Learning Test (RAVLT) assesses auditory learning and memory. Youth are asked to listen to and recall a list of 15 unrelated words over five learning trials. They are then presented with and asked to recall as many words from a second, distractor list of 15 words, and recall of the initial list is then assessed.

  64. Wechsler Intelligence Test for Children-V Matrix Reasoning

    Time frame: Baseline

    This subtest of the Wechsler Intelligence Scale for Children assesses nonverbal reasoning, as well as visual intelligence, part-whole spatial reasoning, perceptual organization, attention to visual detail, and sequencing. Youth are presented with an incomplete array of visually presented stimuli, and asked to select one of four alternatives to complete the array. For participants aged 16 years or over, the Wechsler Adult Intelligence Scale-IV (WAIS-IV) version of this task will be administered.

  65. Little Man Task

    Time frame: Baseline

    The Little Man Task (LMT) assesses visual-spatial processing, including mental rotation. Youth are asked to indicate which hand a figure is using to hold a briefcase after being presented with the figure in one of four positions.

  66. Delay Discounting Task

    Time frame: 6 months

    Delay discounting can be defined as the depreciation of the value of a reward related to the time that it takes to be released. The task is an index of impulsive behaviour. Participants play a game in which they make a choice between an immediate small reward and a delayed larger reward.

  67. Emotional Stroop Task

    Time frame: 6 months

    The Emotional Stroop Task is a modified version of the traditional Stroop task in which participants are required to name the ink color of words with emotional or neutral valence. This task is commonly used to measure the attentional biases toward emotional stimuli typically observed in humans.

  68. Penn Emotion Differentiation Task

    Time frame: 6 months

    The Penn Emotion Differentiation Task measures the social cognition domain of emotion identification - the ability to decode and correctly identify facial expressions of emotion. Youth are shown 40 faces and must determine whether the emotion expressed is happiness, sadness, anger, fear, or none at all.

  69. The Awareness of Social Inference Test (TASIT) - Short Version

    Time frame: 6 months

    The Awareness of Social Inference Test (TASIT) - Short Version measures social cognition using videos of naturalistic everyday conversations in which two actors interact. It has established ecological validity, reliability and construct validity. Alternate forms are available for re-testing.

  70. Parental Bonding Instrument

    Time frame: Baseline

    The Parental Bonding Instrument (PBI) was designed to measure the contribution of parental behavior to the development of appropriate bonds between parents and children. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.

  71. Personality Inventory for DSM-5 Faceted Brief Form

    Time frame: 6 months

    The Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) will be used to examine maladaptive personality traits. The PID-5-FBF is a 100-item self-rated personality trait assessment scale for adolescents and adults. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.

  72. Competitive Sports Questionnaire

    Time frame: 6 months

    This is an 8-item questionnaire originally developed for the TAY study.

  73. International Physical Activity Questionnaire

    Time frame: 6 months

    This measure is a questionnaire measuring physical activities in the last 7 days.

  74. Pain Questionnaire

    Time frame: 6 months

    This measure assesses types of pain and frequency, and the impact of pain on 5-point Likert scales. For each pain item the participant needs to indicate if pain can be explained by a physical accident or diagnosed medical condition.

  75. Puberty Development Scale

    Time frame: 6 months

    This scale contains five items, with the last two items being different for males and females. It assesses the presence of developmental changes associated with puberty. Total scores can range from a minimum of 5 to a maximum of 20, with higher scores indicating the presence of more developmental changes.

  76. Social Media Addiction Questionnaire

    Time frame: Baseline

    The Social Media Addiction Questionnaire (SMAQ) is comprised of questions adapted from the Ontario Student Drug Use and Health Survey. These questions will be used to collect information on screen time use, problematic social media use and video game use, respectively, as reported by the youth participant. Total scores can range from a minimum of 6 to a maximum of 36, with higher scores indicating more problematic use of social media.

  77. Acculturation Questionnaire

    Time frame: 6 months

    The Acculturation Questionnaire will be used to measure speaking and reading skills in English and language preference. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.

  78. Mexican American Cultural Values Scale

    Time frame: 6 months

    The Mexican American Cultural Values Scale (50 items) is used to assess family values of individuals from diverse cultural backgrounds. Total scores can range from a minimum of 50 to a maximum of 250, with higher scores indicating less adherence to the outlined cultural values.

  79. Multigroup Ethnic Identity-Revised

    Time frame: 6 months

    The Multigroup Ethnic Identity-Revised will be used to measure cultural affiliation. This measure contains 6 items that can be rated on a five-point scale from strongly disagree to strongly agree. Total scores can range from a minimum of 6 to a maximum of 24, with higher scores indicating stronger cultural affiliation.

  80. Vancouver Index of Acculturation - Short

    Time frame: 6 months

    The Vancouver Index of Acculturation - Short will be used to measure acculturation with 20 items that can be rated from disagree to agree on a 9-point scale. Total scores can range from a minimum of 10 to a maximum of 90, with higher scores indicating greater acculturation.

  81. Parental Monitoring

    Time frame: 6 months

    Family and social influences including parental monitoring and interactions with family members will be measured using the Parental Monitoring questionnaire. Total scores can range from a minimum of 5 to a maximum of 25, with higher scores indicating higher parental involvement.

  82. Prosocial Scale from the Strengths and Difficulties Questionnaire

    Time frame: 6 months

    Family and social influences including prosocial behaviors and interactions with family members will be measured using the Prosocial Scale. Total scores can range from a minimum of 0 to a maximum of 10, with higher scores indicating more prosocial behaviors.

  83. Conflict Behavior Questionnaire

    Time frame: 6 months

    Family and social influences including interactions with family members will be measured using the Conflict Behavior Questionnaire. Total scores can range from a minimum of 0 to a maximum of 20, with higher scores indicating the presence of more conflict-related behaviors.

  84. Gender Dysphoria Questionnaire for Adolescents and Adult

    Time frame: 6 months

    In addition to self-reported gender obtained using the demographic protocol, gender expression will be measured using the Gender Dysphoria Questionnaire for Adolescents and Adults. Total scores can range from a minimum of 27 to a maximum of 135, with higher scores indicating greater satisfaction and less gender-related distress.

  85. Personal Attributes Questionnaire

    Time frame: 6 months

    In addition to self-reported gender obtained using the demographic protocol, gender identity variability will be measured using the Personal Attributes Questionnaire. Total scores can range from a minimum of 0 to a maximum of 96, with higher scores indicating stronger self-perceptions of gender attributes.

  86. Adverse Life Events Scale

    Time frame: 6 months

    Life events and current life stress will be assessed in all participants below age 18 using The Adverse Life Events Scale. Total scores can range from a minimum of 0 to a maximum of 25, with higher scores indicating more adverse life events and/or related stress.

  87. Childhood Trauma Questionnaire - Short Form

    Time frame: 6 months

    All participants will be administered the Childhood Trauma Questionnaire - Short Form to identify traumatic childhood conditions. Total scores can range from a minimum of 28 to a maximum of 125, with higher scores indicating greater exposure to traumatic childhood conditions.

  88. Connor-Davidson Resilience Scale

    Time frame: 6 months

    Individual resilience in the face of stress will be measured using a brief, two-item version of the Connor-Davidson Resilience Scale. Total scores can range from a minimum of 0 to a maximum of 8, with higher scores indicating higher resilience.

  89. Everyday Discrimination Scale

    Time frame: 6 months

    Lifetime discriminatory experiences will be assessed in all participants using a Canadian adaptation of the Everyday Discrimination Scale. Total scores can range from a minimum of 5 to a maximum of 25, with higher scores indicating greater discriminatory experiences.

  90. Life Events Checklist

    Time frame: 6 months

    The Life Events Checklist (LEC) is designed to screen for potentially traumatic experiences that may contribute to psychological distress. Participants aged 18 and above will be administered the Life Events Checklist.

  91. Inventory for School Risk and Protective Factors

    Time frame: 6 months

    All participants' school environments will be characterized using the Inventory for School Risk and Protective Factors measure from the ABCD study. Total scores can range from a minimum of 6 to a maximum of 24, with higher scores indicating greater protective factors.

  92. Neighbourhood Safety and Crime Scale

    Time frame: 6 months

    In the proximal social environment, neighbourhood safety will be measured using a three-item Neighbourhood Safety and Crime Scale. Total scores can range from a minimum of 3 to a maximum of 15, with higher scores indicating lower perceived neighbourhood safety.

  93. 3-Digit Postal Codes

    Time frame: Baseline

    3-digit postal codes of participants (collected as part of routine demographic data) will be used to obtain census-based neighbourhood-level marginalization data; this will allow each participant's neighbourhood to be characterized by the level of social and economic marginalization as well as ethnic concentration. At the time of cohort entry, the first 3 digits of each participant's postal code are collected based on the participant's residential address. Any change in a participant's residential address will also be recorded during assessment periods during the study to account for changes in exposure to socio-environmental factors.

  94. 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

    Caregivers will complete the Parent General Behaviour Inventory-10 Mania, which measures the presence and severity of mania. Total scores can range from a minimum of 0 to a maximum of 30, with higher scores indicating greater presence and severity of mania.

  95. Video Game Addiction Questionnaire

    Time frame: Baseline

    The Video Game Addiction Questionnaire (VGAQ) is comprised of questions adapted from the Ontario Student Drug Use and Health Survey. These questions will be used to collect information on screen time use, problematic social media use and video game use, respectively, as reported by the youth participant. Total scores can range from a minimum of 6 to a maximum of 36, with higher scores indicating more problematic use of video games.

  96. Student Adaptation to College Questionnaire

    Time frame: Baseline

    The Student Adaptation to College Questionnaire (SACQ) is a self-report questionnaire measuring educational attainment. Participants attending post-secondary school will also be asked to complete the SACQ. Total scores can range from a minimum of 67 to a maximum of 603, with higher scores indicating better overall adjustment to college life.

Study contacts

Contact information is provided by the study sponsor or research team.

Janani Selvachandran, PhD

CONTACT

[email protected]

437-441-2294

Louise Gallagher, MD, PhD

CONTACT

[email protected]

416-535-8501 ext. 33566

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Ontario Brain Institute

Registry information

Official study title

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

Acronym: CALM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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