The objective of this study is to characterise and validate multidimensional latent risk and resilience mental health trajectories in a trans-syndromal sample of help-seeking young people, including identifying genetic, environmental, biological,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Young people between the age of 12-24 years, accessing outpatient specialized mental health services for the first time
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome will be overall mental health measured with MyLifeTracker.
This is a scale that consists of five items targeting areas of importance to
youth: general well-being, day-to-day activities, relationships with friends,
relationships with family, and general coping.
Secondary outcome
Secondary outcomes include the following areas: clinical, cognition,
self-reported assessment, digital phenotyping, and biological data.
Participants can be asked to participate in subparts of the study. Among
others, a qualitative study will be performed to retrieve more insight into the
lived experience of participants. Additionally, a subgroup will use 'experience
sampling method'. For all subparts, participants will be asked to give
additional informed consent.
Background summary
Improving characterization of mental health trajectories and its potential
determinants in young people will enable the identification of actionable
targets and guide targeted preventive and therapeutic interventions to reduce
mental illness burden across the lifespan. Studies in help-seeking young people
(i.e., showing early manifestations of mental distress and already in need of
care) are necessary to complement the information provided by previous studies
assessing the effect of genetic and environmental factors on mental health
trajectories in the general population so as to increase their clinical
translatability. The complex and dynamic nature of mental illness requires
trans-syndromal multimodal studies using large-scale multidimensional data
analysis to achieve this aim.
Study objective
The objective of this study is to characterise and validate multidimensional
latent risk and resilience mental health trajectories in a trans-syndromal
sample of help-seeking young people, including identifying genetic,
environmental, biological, clinical, cognitive, and digital predictors of
functional outcomes, over a 24-month follow-up period.
Study design
This study is a prospective, non-interventional, observational study consisting
of the following assessments, at baseline, and at 3, 6, 12, 18 and 24 month
follow-up.
Study burden and risks
The risks and burden associated with this study are minimal, collecting digital
and clinical data as well as biomaterials (saliva, blood) only after informed
consent. Although there are a substantial number of assessments, only the first
visit is in-site, and the time allocated for it is coherent with standard
clinical psychological assessments. A risk is a breach in data-protection.
However, all GDPR rules are complied with and no information traceable to the
participant will be used after informed consent, only coded information.
The potential individual benefits are those associated with close monitoring
and thorough examination of participants. The use of self-reported measures may
identify potential risks in the participants (e.g., suicide, traumatic
experiences) that may be unknown to the clinicians. These events will be
reviewed and communicated to the treating clinician and to other institutions,
if required, according to applicable local regulations.
Vijverdalseweg 1
Maastricht 6226 NB
NL
Vijverdalseweg 1
Maastricht 6226 NB
NL
Listed location countries
Age
Inclusion criteria
• Age between 12-24 years.
• Less than one month from the first contact with mental health services.
• Good command of the languages used in the study.
• Written informed consent by the participant, their parents if minors, or
legal representatives if appropriate.
Exclusion criteria
• Intellectual disability with associated functional impairment.
• Severe neurological or medical condition.
• Genetically confirmed neurobehavioral syndromes.
• Participants that exhibit significant difficulties to complete the
self-reported questionnaires or those whose genetic or biological analysis
confirm an underlying health or genetic condition will be excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86050.068.24 |