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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04596345
Other study ID # PSI.CPE.20.01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2020
Est. completion date June 30, 2023

Study information

Verified date October 2023
Source Universidad de las Americas - Quito
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Emerging adulthood (18-29 years) is a critical stage in lifespan development. During this stage, people experience instability: shifts from their families of origin, breakups of relationships and job changes are frequent before most young adults stabilize their lives and make more lasting decisions. This study seeks to understand the psychological distress of emerging adults in Quito, Ecuador and define how it varies over a year.


Description:

Emerging adulthood is often a period of some instability with relationship changes and often a series of job changes before life trajectories clarify and more lasting decisions are possible. These changes often produce distress and they might explain why most of the symptoms that impact the individual's mental health throughout their lives appear at this stage, although full-blown disorders are often only diagnosed subsequently. There are several studies that describe the prevalence of mental disorders in this age group, however, there are few studies that refer to how psychological distress changes during this phase of emotional, social, and financial instability. The few existent studies refer mostly to college student populations, with relative neglect of the non-student populations. The objective of this study is to analyze the intraindividual changes in psychological distress of emerging adults over one year. These changes will be compared between those participants who are college students and those who are not. Sociodemographic data will be recorded in the first assessment and the last assessment, while psychological distress and health-related quality of life will be monitored bimonthly for seven assessment points in total. Everyday relevant events will be also recorded bimonthly for seven assessment points, and this information will be used as a time-varying covariate. An electronic survey will be used for data collection through formr system (https://formr.org/). The results of this research will show if the distress changes significantly in the studied population for one year and it will be possible to identify some of the events and variables that are related to these changes. This knowledge might help to create interventions that are tailored to the needs of this population.


Recruitment information / eligibility

Status Completed
Enrollment 1168
Est. completion date June 30, 2023
Est. primary completion date March 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility Inclusion Criteria: - Competence to read and understand Spanish - Living in Ecuador - Being a student (for the student cohort) - Not attending to a formal student program (for the non-student cohort) Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Ecuador Metropolitan District Quito

Sponsors (1)

Lead Sponsor Collaborator
Universidad de las Americas - Quito

Country where clinical trial is conducted

Ecuador, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change on the Clinical Outcomes in Routine Evaluation (CORE) A 34-item self-reported measure that assess psychological distress and how it changes considering four dimensions: subjective well-being (four items), problems and or symptoms (twelve items), life function (twelve items) and risk to self and others (six items). Higher scores indicate higher psychological distress. It is measure that can be downloaded free of charge from: www.coresystemtrust.org.uk. The Clinical Outcomes in Routine Evaluation- Outcome Measure(CORE-OM) has shown good psychometric properties in college students (and a non-student general population sample) from Ecuador (http://dx.doi.org/10.1186/s40359-020-00443-z) One year (seven assessment points at two-month intervals)
Secondary EuroQol five-dimensions - three-level (EQ-5D-3L) A 5-item self-report measure of health-related quality of life states in adults, considering five dimensions (Mobility, Self-care, Usual activities, Pain & discomfort, Anxiety & Depression), each of which has three severity levels that are described by statements appropriate to that dimension. As result a 5-digit number describes person's health state profile. Higher scores represent more problems with regard to each dimension. One year (seven assessment points at two-month intervals)
Secondary EuroQol Visual Analogue Scale (EQ VAS) This scale records the patient's self-rated health on a vertical visual analogue scale that ranges from 0= 'Best imaginable health state' to 100 = 'Worst imaginable health state'. The VAS will be used as a quantitative measure of health outcome . One year (seven assessment points at two-month intervals)
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