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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

Tracking Information
First Submitted Date October 7, 2020
First Posted Date October 22, 2020
Last Update Posted Date May 17, 2022
Actual Study Start Date October 15, 2020
Actual Primary Completion Date March 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2020)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 15, 2020)
  • 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.
  • 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 .
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychological Distress in Emerging Adulthood: A Longitudinal Study
Official Title Psychological Distress in Emerging Adulthood: A Longitudinal Study
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Psychological Distress
Intervention Not Provided
Study Groups/Cohorts
  • 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.

Publications * Paz C, Osejo-Taco G, Evans C. Trajectories of success and/or distress: protocol for an observational cohort study investigating changing psychological distress among emerging Ecuadorian adults over a year. BMJ Open. 2021 Dec 20;11(12):e056361. doi: 10.1136/bmjopen-2021-056361.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 15, 2020)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2022
Actual Primary Completion Date March 7, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ecuador
Removed Location Countries  
 
Administrative Information
NCT Number NCT04596345
Other Study ID Numbers PSI.CPE.20.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Clara Paz, Universidad de las Americas - Quito
Original Responsible Party Same as current
Current Study Sponsor Universidad de las Americas - Quito
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Universidad de las Americas - Quito
Verification Date May 2022