NCT06954064

Brief Summary

This study aims at collecting continuous mobile-based devices data for determining emotional resilience factors and childhood abuse load profiles for stress and mental health problems.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

March 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

April 24, 2025

Last Update Submit

August 27, 2025

Conditions

Emotional Resilience

Outcome Measures

Primary Outcomes (2)

  • Resilience factors

    The Rugged Resilience Measure (RRM) is a 10-item scale measuring internal essential qualities associated with resilience, using 5-point Likert scales for scoring, from 1 = not at all to 5 = a lot.

    One month, weekly (5 administrations)

  • Mental Health

    The Depression, Anxiety, and Stress Scales (DASS-21) are comprised of 21 items measuring the frequency of symptoms that can be bothering individuals in the sphere of depression, anxiety and stress. The scoring is based on Likert scales from 0 = Never to 4 = Almost always.

    One month, weekly (5 administrations)

Study Arms (1)

Adolescents and young adults

Adolescents and young adults will be recruited from various schools and university programs in Cluj-Napoca.

Other: No intervention will be applied.

Interventions

No intervention will be applied.OTHER

No intervention will be implemented in this study, as the questionnaires will serve an exploratory purpose.

Adolescents and young adults

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

School- and university-aged students recruited from educational institutions in Cluj-Napoca.

You may qualify if:

  • adolescents and young adults between 10 and 24 years old provided with written parental consent where applicable

You may not qualify if:

  • intellectual disability or physical limitations precluded the use of the computer program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, 400015, Romania

Location

Study Officials

  • Oana A. David, Ph.D

    Babes-Bolyai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor PhD

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

March 10, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)