Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health Trajectories

NCT06978452 | Recruiting

• 1 other identifier: 2024-960
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health (BLOOM) is a project that aims to overcome age and diagnostic boundaries to generate person-specific longitudinal profiles of mental health in youth aged 9 to 25. The overarching objective is to lay the informational foundation to accurately predict both clinical outcomes and opportunities to optimize health trajectories. This project will recruit youth in need without any mental health diagnosis and follow them annually for 5 years. The present study includes assessment of antecedents, opportunities and outcomes that will establish eligibility for preventive interventions

Conditions

Depression - Major Depressive Disorder; Bipolar; Psychosis; Eating Disorder NOS; ADHD; Substance Use Disorder (SUD); OCD

Keywords

antecedents; mental health prevention; resilience; access to care; help-seeking; youth in needs; biomarker; speech; language; cognition

Outcome Measures

Primary Outcomes (1)

• Number of new onsets of one of the seven mental illnesses as per DSM-5 criteria

  By applying a detailed diagnostic screen we will be able to capture all emerging mental illnesses as per the existing schedule of classification if present. But our primary outcome of interest (DMDs) is defined as a new onset of illnesses known to involve substantial functional impairment over multiple domains. These are moderate/severe major depressive disorder, bipolar disorder type I or type 2, schizoaffective disorder, schizophrenia, or schizophreniform disorder, anorexia and bulimia nervosa, OCD, moderate/severe ADHD, moderate or severe substance use disorder (SUD) all according to DSM-5 (as per DSM-5 Text Revision, updated September 2023). Notably, while epidemiological data indicates that features of some of these disorders (e.g. ADHD, OCD) begin at ages younger than 9, the mean age of diagnosis continues to be much later in practice.

  From screening to 5 years of follow-up.

Other Outcomes (1)

• Time-to-onset of severe psychopathology based on InterRAI instrument

  baseline, 1,2,3,4 and 5 years

Study Arms (2)

Help seeking group

Primary care mental health service providers within the CIUSSS-ODIM catchment area will be the major referral source for this group. Youth and families referred to or self-referring for mental health needs to CLSCs at Dorval-Lachine-LaSalle, CLSC Pierrefonds/Lac-Saint-Louis, Social Paediatrics Clinics and Aire-Ouverte centres throughout the CIUSSS-West Island catchment will be approached by a member of these programmes to assess interest. A screening contact (on site or via telephone) by a member of the research team (who will work on site with clinical teams) will follow to review eligibility criteria. To increase uptake and reduce clinician burden, information leaflets and posters will be made available at the waiting rooms, webpages and social media sites of these youth programmes.

Non help seeking group

Parents referral pathway: Youth will be recruited through their parents, patients of psychiatric clinics at the CIUSSS-ODIM. Parents will be approached by health professionals. A screening contact by a member of the research team will follow to review eligibility criteria. Other form of recruitment is non-profit organisations serving people living with mental illness, such as the Schizophrenia Society of Quebec as well as primary care practitioners caring for parents satisfying the eligibility criteria. Information leaflets and posters will be made available at the waiting rooms of these clinics and shared with the partner agencies. Social agencies referral pathway: Youth who have contacts with community agencies that provide various forms of social assistance will be recruited through printed and digital advertising. Direct contacts as well as referrals from agency workers and volunteers will be screened by a member of the research team. Physical health based referral pathway: Adv

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Help-seeking group: Primary care mental health service providers within the CIUSSS-ODIM catchment area will be the major referral source for this group. Youth and families referred to or self-referring for mental health needs to CLSCs at Dorval-Lachine-LaSalle, CLSC Pierrefonds/Lac-Saint-Louis, Social Paediatrics Clinics and Aire-Ouverte centres throughout the CIUSSS-West Island catchment will be approached by a member of these programmes to assess interest. A screening contact (on site or via telephone) by a member of the research team (who will work on site with clinical teams) will follow to review eligibility criteria. To increase uptake and reduce clinician burden, information leaflets and posters will be made available at the waiting rooms, webpages and social media sites of these youth programmes (See the leaflet: Portraying Your Mental Health). Non help-seeking group: Parents referral pathway: For this group, youth will be recruited through their parents, who are current

You may qualify if:

• Specific eligibility criteria:
• Help-seeking group: At least one help-seeking contact made with a primary care clinical service provider or agency (e.g, paediatric/family physician clinic, CLSC or Aire Ouverte) for a mental health concern (i.e., clinical needs).
• Non help-seeking group:
• At least one of the birth parents or siblings have received psychiatric care for a diagnosis of DMDs (i.e., family needs) OR Being in contact with community agencies that provide youth-centred social services for food, housing, social discrimination (e.g., racialized youth, LGBTQ2SIA+) (i.e., social needs) OR Having a diagnosed chronic physical illness that is expected to require treatment for \>12 months (e.g., diabetes, asthma to name a few) (i.e., physical health needs)

You may not qualify if:

• Importantly, no one will be excluded based on sex, gender, health insurance status, ethnicity, income status, ability to travel or living arrangements. If a participant initially approached through the referral pathways for non help-seeking individuals turns out to have had at least one help-seeking contact for a mental health concern (i.e., clinical needs), the participant will still be included but classified as part of the help-seeking group. We anticipate non help-seeking referrals to satisfy more than one criteria. Their occurrence and distribution will be recorded in detail as part of our assessment procedure.

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead

Study Sites (1)

Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Ouest-de-l'Île-de-Montréal

Montreal, Quebec, H4H 1R3, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The Bloom study will collect from a sub-set of the participants a variety of biological samples. Venous blood will be collected for both plasma and serum, a dried blood spot card, and a saliva sample and buccal cells will be collected from swabbing their cheeks. Samples will either be sent for analysis or transformed into a derivative that will be analyzed. Serum samples will be analyzed for fasting glucose, insulin, triglycerides and cholesterol. Plasma samples will be used for the extraction of brain derived extracellular vesicles. miRNA will be extracted from the Dried Blood Spots and sent for sequencing analysis. Buccal samples will be extracted for DNA and subsequently genotyped while saliva samples will be used to analyze levels of C-Reactive Protein, TNF-alpha, IL-6, IL-8 and IL-1β. Any sample or derivative that is not completely depleted by initial analysis will be retained for future developments or repeats as needed

MeSH Terms

Conditions

Psychotic Disorders; Feeding and Eating Disorders; Attention Deficit Disorder with Hyperactivity; Substance-Related Disorders; Speech; Language

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Chemically-Induced Disorders; Verbal Behavior; Communication; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 18, 2025

Record last verified: 2024-11

Locations

CA (1)