NCT04596345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,168

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

October 7, 2020

Last Update Submit

October 23, 2023

Conditions

Psychological Distress

Keywords

Young AdultLife Change EventsStudentsMental HealthObservational StudyLongitudinal StudiesSurveys and QuestionnairesSelf Report

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • EuroQol five-dimensions - three-level (EQ-5D-3L)

    One year (seven assessment points at two-month intervals)

  • EuroQol Visual Analogue Scale (EQ VAS)

    One year (seven assessment points at two-month intervals)

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metropolitan District

Quito, EC170503, Ecuador

Location

Related Publications (2)

  • Paz C, Evans C. A comparison of mental health of student and not student emerging adults living in Ecuador. Sci Rep. 2023 Jan 27;13(1):1487. doi: 10.1038/s41598-023-27695-0.

    PMID: 36707675DERIVED

  • 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.

    PMID: 34930747DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 22, 2020

Study Start

October 15, 2020

Primary Completion

March 7, 2022

Study Completion

June 30, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

EC(1)