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Psychological Distress in Emerging Adulthood: A Longitudinal Study (DistressEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596345
Recruitment Status : Active, not recruiting
First Posted : October 22, 2020
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Clara Paz, Universidad de las Americas - Quito

Study Description
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Brief 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.

Condition or disease
Psychological Distress

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychological Distress in Emerging Adulthood: A Longitudinal Study
Actual Study Start Date : October 15, 2020
Actual Primary Completion Date : March 7, 2022
Estimated Study Completion Date : September 30, 2022
Groups and Cohorts
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Group/Cohort
University students

This group will include all those participants who declare to be attending a study program to get a higher education degree.

No intervention will be applied.
Non-university-attending peers

This group will include all those participants who are not attending a study program to get a higher education degree.

No intervention will be applied.


Outcome Measures
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Primary Outcome Measures :
  1. Change on the Clinical Outcomes in Routine Evaluation (CORE) [ Time Frame: One year (seven assessment points at two-month intervals) ]
    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)


Secondary Outcome Measures :
  1. EuroQol five-dimensions - three-level (EQ-5D-3L) [ Time Frame: One year (seven assessment points at two-month intervals) ]
    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.

  2. EuroQol Visual Analogue Scale (EQ VAS) [ Time Frame: One year (seven assessment points at two-month intervals) ]
    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 .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population will be emerging adults from Ecuador students and non-students as one objective is to compare psychological distress variability between both populations.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596345


Locations
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Ecuador
Metropolitan District
Quito, Ecuador, EC170503
Sponsors and Collaborators
Universidad de las Americas - Quito
  Study Documents (Full-Text)

Documents provided by Clara Paz, Universidad de las Americas - Quito:
Statistical Analysis Plan  [PDF] February 28, 2022

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clara Paz, Researcher, Universidad de las Americas - Quito
ClinicalTrials.gov Identifier: NCT04596345    
Other Study ID Numbers: PSI.CPE.20.01
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clara Paz, Universidad de las Americas - Quito:
Young Adult
Life Change Events
Students
Mental Health
 Observational Study
Longitudinal Studies
Surveys and Questionnaires
Self Report