Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-24
SponsorCentre for Addiction and Mental Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
The CALM network will recruit children and youth aged 11-24 who have sought, are seeking, or are accessing mental health care from 5 partner sites in Ontario (Centre for Addiction and Mental Health, Hospital for Sick Children, McMaster Children's Hospital, Children's Hospital of Eastern Ontario, and The Royal Ottawa Mental Health Centre) and 1 partner site in Alberta (Alberta Health Services) as well as the broader community. Caregivers of CALM participants will be asked to complete caregiver specific questionnaires (self-report and completing the measures based on their child/youth). When a CALM child/youth participant is approached for the study, we will ask said participant if we can contact their caregiver to participate in the study. We will then approach the caregiver for consent. No external recruitment of non-CALM participants caregivers will be implemented.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,620 Participants
are grouped into 2 trial groupsGroup A: MOT
Group B: Deep Phenotyping
Trial outcomes
Primary outcomes
1
Diagnostic Assessment for the Health Spectrum
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.
Time frame
Baseline and 24 months2
Adolescent Health History
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.
Time frame
Baseline, 12 months, 24 months3
Assessment of Quality of Life
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.
Time frame
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months4
Brain-CODE Demographic Form
The Brain-CODE Demographic Form is a standard form developed by Brain-CODE to capture demographic information from participants.
Time frame
Baseline, 12 months, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre for Addiction and Mental Health
Lead sponsor
Ontario Brain Institute
Collaborator
Source ClinicalTrials.gov