Resilience, PsychologicalNCT04371250
Study of Resilience and Loneliness in Youth (18 - 25 Years Old) During the COVID-19 Pandemic Lock-down Measures.
An observational study of Resilience, Psychological and Loneliness, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all European countries. This online survey assesses these measures implications on Mental Health in emerging adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Psychological, Loneliness, Youth
- What is being tested?
- Survey and Questionnaire
- How many people
- 800 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Apr 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy youth living in a European Country where SARS-CoV2 Pandemic Lock-down Measures are underway.
Who may be able to join
- French-speaking or Italian-speaking
- Subjects who accepted to participated to the online survey
- Inhabitants of a European country where SARS-CoV2 Pandemic Lock-down Measures are underway
- Survey filling date up to one week after the end of Lock-down Measures in the Country of residence
Who cannot join
- Incomplete surveys
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health Implications During and After the COVID-19 Pandemic Lock-down Measures in Youth (18 - 25 Years Old) in French-Speaking Belgium and Italy: Resilience and Loneliness Evaluation.
The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all European countries.
This online survey assesses these measures implications on Mental Health in emerging adults.
The questionnaires evaluate two psychometric variables (Resilience and Loneliness) and Mental Health status (mental health professional help-seeking, use of psychotropic drugs, or possible diagnosis) before and during Lock-down Measures.
At least 600 healthy participants aged form 18 to 25 years old will be attended to fill the survey during the SARS-CoV2 Pandemic Lock-down Measures.
- Being tested
- Survey and Questionnaire
- Keywords
- Mental Health, Emerging Adulthood
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey and QuestionnaireOther
Resilience and Loneliness questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Youth | Assessed group Receives: Other: Survey and Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rated measure of Resilience
Measured with the Resilience Scale for Adults (RSA).
Measured: Up to 1 week after the end of the lock-down measures
Self-rated measure of Loneliness
Measured with the UCLA (University of California, Los Angeles) Loneliness Scale.
Measured: Up to 1 week after the end of the lock-down measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start30 Apr 2020
- Primary completion31 May 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Resilience, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles, King Baudouin Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371250
- Sponsor's protocol ID
- SRB2020_158
- Status last verified
- Feb 2022
- First submitted
- 22 Apr 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boffo, M., Mannarini, S., & Munari, C. (2012). Exploratory Structure Equation Modeling of the UCLA Loneliness Scale: A contribution to the Italian adaptation. TPM: Testing, Psychometrics, Methodology in Applied Psychology, 19(4).
Bonfiglio NS, Renati R, Hjemdal O, Friborg O. The resilience scale for adults in italy: A validation study comparing clinical substance abusers with a nonclinical sample. Psychol Addict Behav. 2016 Jun;30(4):509-15. doi: 10.1037/adb0000176. Epub 2016 Mar 31.
PubMed 27031088Friborg, O., Martinussen, M., & Rosenvinge, J. H. (2006). Likert-based vs. semantic differential-based scorings of positive psychological constructs: A psychometric comparison of two versions of a scale measuring resilience. Personality and Individual Differences, 40(5), 873-884. https://doi.org/10.1016/j.paid.2005.08.015
Grace, G. D. E., Joshi, P., Pelletier, R., & Laval, U. (1993). L'Echelle de solitude de l'Universite Laval ( ESUL ): validation canadienne-francaise du UCLA Loneliness Scale. (1959), 12-27.
Hjemdal, O., Friborg, O., Braun, S., Kempenaers, C., Linkowski, P., & Fossion, P. (2011). The resilience scale for adults: Construct validity and measurement in a Belgian sample. International Journal of Testing, 11(1), 53-70. https://doi.org/10.1080/15305058.2010.508570
Kessler RC, Amminger GP, Aguilar-Gaxiola S, Alonso J, Lee S, Ustun TB. Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry. 2007 Jul;20(4):359-64. doi: 10.1097/YCO.0b013e32816ebc8c.
PubMed 17551351Marcoen A, Goossens L, Caes P. Lonelines in pre-through late adolescence: Exploring the contributions of a multidimensional approach. J Youth Adolesc. 1987 Dec;16(6):561-77. doi: 10.1007/BF02138821.
PubMed 24277491
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Implications During and After the COVID-19 Pandemic Lock-down Measures in Youth (18 - 25 Years Old) in French-Speaking Belgium and Italy: Resilience and Loneliness Evaluation.
- ClinicalTrials.gov ID
- NCT04371250
- Acronym / sponsor ID
- SRB2020_158
- Keywords
- Mental Health, Emerging Adulthood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles, King Baudouin Foundation
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all European countries.
This online survey assesses these measures implications on Mental Health in emerging adults.
The questionnaires evaluate two psychometric variables (Resilience and Loneliness) and Mental Health status (mental health professional help-seeking, use of psychotropic drugs, or possible diagnosis) before and during Lock-down Measures.
At least 600 healthy participants aged form 18 to 25 years old will be attended to fill the survey during the SARS-CoV2 Pandemic Lock-down Measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth | – | Other: Survey and QuestionnaireAssessed group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy youth living in a European Country where SARS-CoV2 Pandemic Lock-down Measures are underway.
Key inclusion criteria (4 listed)
- French-speaking or Italian-speaking
- Subjects who accepted to participated to the online survey
- Inhabitants of a European country where SARS-CoV2 Pandemic Lock-down Measures are underway
- Survey filling date up to one week after the end of Lock-down Measures in the Country of residence
Key exclusion criteria (1 listed)
- Incomplete surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey and QuestionnaireResilience and Loneliness questionnaires | Other | Youth |
Primary outcome
Self-rated measure of Resilience
Time frame: Up to 1 week after the end of the lock-down measures
Measured with the Resilience Scale for Adults (RSA).
Self-rated measure of Loneliness
Time frame: Up to 1 week after the end of the lock-down measures
Measured with the UCLA (University of California, Los Angeles) Loneliness Scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- BackgroundBoffo, M., Mannarini, S., & Munari, C. (2012). Exploratory Structure Equation Modeling of the UCLA Loneliness Scale: A contribution to the Italian adaptation. TPM: Testing, Psychometrics, Methodology in Applied Psychology, 19(4).
- Background: PubMed 27031088Bonfiglio NS, Renati R, Hjemdal O, Friborg O. The resilience scale for adults in italy: A validation study comparing clinical substance abusers with a nonclinical sample. Psychol Addict Behav. 2016 Jun;30(4):509-15. doi: 10.1037/adb0000176. Epub 2016 Mar 31.
- BackgroundFriborg, O., Martinussen, M., & Rosenvinge, J. H. (2006). Likert-based vs. semantic differential-based scorings of positive psychological constructs: A psychometric comparison of two versions of a scale measuring resilience. Personality and Individual Differences, 40(5), 873-884. https://doi.org/10.1016/j.paid.2005.08.015
- BackgroundGrace, G. D. E., Joshi, P., Pelletier, R., & Laval, U. (1993). L'Echelle de solitude de l'Universite Laval ( ESUL ): validation canadienne-francaise du UCLA Loneliness Scale. (1959), 12-27.
- BackgroundHjemdal, O., Friborg, O., Braun, S., Kempenaers, C., Linkowski, P., & Fossion, P. (2011). The resilience scale for adults: Construct validity and measurement in a Belgian sample. International Journal of Testing, 11(1), 53-70. https://doi.org/10.1080/15305058.2010.508570
- Background: PubMed 17551351Kessler RC, Amminger GP, Aguilar-Gaxiola S, Alonso J, Lee S, Ustun TB. Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry. 2007 Jul;20(4):359-64. doi: 10.1097/YCO.0b013e32816ebc8c.
- Background: PubMed 24277491Marcoen A, Goossens L, Caes P. Lonelines in pre-through late adolescence: Exploring the contributions of a multidimensional approach. J Youth Adolesc. 1987 Dec;16(6):561-77. doi: 10.1007/BF02138821.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resilience, Psychological and Loneliness, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rated measure of Resilience (time frame: Up to 1 week after the end of the lock-down measures). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04371250, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.