Building resilience and resources to reduce depression and anxiety in young people from urban neighbourhoods in Latin America
| ISRCTN | ISRCTN99961401 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99961401 |
| Secondary identifying numbers | MR/S03580X/1 |
- Submission date
- 14/12/2020
- Registration date
- 16/12/2020
- Last edited
- 17/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The number of people with depression and anxiety greatly increases during adolescence. Adolescents who live in big cities more commonly experience stressful events such as conflict, poverty, substance misuse, and social isolation. This includes adolescents from Latin America, which is the most urban part of the world.
Although many individuals experience stressful events, the majority do not develop either depression or anxiety. Furthermore, up to half of the people who do develop these conditions recover within a year. This raises the question of what resources help in the prevention of depression and anxiety, and help people recover.
This study aims to understand the resources that are linked to either recovery or the prevention of depression and anxiety, so that new approaches can be developed to treat depression and anxiety. This study will focus on young people living in three large Latin American cities: Buenos Aires, Bogotá, and Lima.
Who can participate?
Adolescents (aged 15-16 years old) and young adults (aged 20-24 years old) living in specific areas of Bogotá, Buenos Aires, and Lima. Adolescents will need their parent's or guardian's consent to participate in this study.
What does the study involve?
This study will compare a group of adolescents (15-16 years old) and young adults (20-24 years old) with depression and anxiety with the same number of adolescents and young adults without depression and anxiety. Participants will all be asked to complete questionnaires about symptoms of mental distress, personal factors such as health behaviours and coping with problems, and social factors including relationships with friends and family. The study will test if there are differences between the two groups, and find out which resources are linked to prevention.
The individuals who have depression and anxiety will be asked to complete the same questionnaires after 12 and 24 months, and also a few questionnaires after the first six months. We will compare individuals who have recovered from depression and anxiety to those who did not. This will tell us about the resources that are linked to recovery.
In a separate but linked Experience Sampling Method (ESM) study, a subset of 150 participants will be invited to complete questionnaires using a mobile phone app. These young people will be asked to answer the same, very short ESM questionnaire between five and eight times-per-day over a period of seven days. This will include questions about mood, stress levels, what the person is doing, and who they are with. This will provide information about resources that are linked to recovery that happens over a short period of time, and allow the study team to compare these with resources that help recovery over a longer period of time (one year). Eighteen participants aged 15-24 years old, will be invited to test these study procedures using the mobile phone app before the ESM study takes place.
What are the possible benefits and risks of participating?
The information that participants provide will help with the aims of this study, to identify and understand the resources that help young people to prevent and recover from depression and/or anxiety. This might lead to new approaches to reduce the burden of mental distress in young people in Latin America and beyond.
There are no expected risks linked with taking part in this study, but participants may feel uncomfortable or saddened by some of the questions. The research team is trained to talk about these topics in a warm and respectful way, and participants may decide not to answer specific questions.
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
From May 2020 to August 2024
Who is funding the study?
The Medical Research Council (UK)
Who is the main contact?
Catherine Fung
c.fung@qmul.ac.uk
Contact information
Public
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0002-3220-6930 |
|---|---|
| Phone | +44 (0)20 7540 4380 ext. 2312 |
| c.fung@qmul.ac.uk |
Scientific
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
| ORCID ID |
0000-0001-9864-3394 |
|---|---|
| Phone | +44 (0)20-75404210 |
| s.priebe@qmul.ac.uk |
Study information
| Study design | Multi-centre cross-sectional study, longitudinal cohort study, and experience sampling method study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | ISRCTN99961401_PIS_ESM young adults_v1.0_07Sept2020.pdf |
| Scientific title | Building resilience and resources to reduce depression and anxiety in young people from urban neighbourhoods in Latin America (OLA) |
| Study acronym | OLA |
| Study hypothesis | 1. To determine whether characteristics, resources, and activities differ between young people with and without depression and/or anxiety 2. To identify which characteristics, resources, and activities in young people are associated with recovery from depression and/or anxiety 3. To determine whether young people have similar characteristics, and use similar resources and activities for short-term recovery (within hours or days) as for long-term recovery (over one year) |
| Ethics approval(s) | 1. Approved 10/11/2020, Ethics Committee in Biomedical Research, Alberto C. Taquini Institute for Translational Medicine Research (Faculty of Medicine, University of Buenos Aires, Marcelo T. de Alvear 2270, C1122 AAJ, Cuidad Autonoma de Buenos Aires, Argentina; +54-11 5285-2751/2/3; infotaquini@fmed.uba.ar) 2. Approved 20/11/2020, Faculty of Medicine - Research and Ethics Committee of the Pontificia Universidad Javeriana, Bogota (Hospital Universitario San Ignacio, Carrera 7a No 40-62, Piso 2, Bogota, Colombia; +57-1 3208320 ext. 2770 - 2879227; ciei@husi.org.co), ref: FM-CIE-1138-20 3. Approved 16/11/2020 Institutional Ethics Committee of Research of the Universidad Peruana Cayetano Heredia (Av. Honorio Delgado 430, Apartado postal 4314, SMP Lima - Peru; +51 1 319-0000 ext. 201352; duict@oficinas-upch.pe), ref: 581-33-20 4. Approved 16/11/2020, Queen Mary Ethics of Research Committee (Room W104, Queen's Building, Mile End Road, London, UK, E1 4NS; +44 (0)20 7882 7915/6947; research-ethics@qmul.ac.uk), ref: QMERC2020/02 |
| Condition | Depression and anxiety in adolescents and young adults |
| Intervention | A cross-sectional study will be used to compare 340 young people per country with depression and/or anxiety with 340 young people per country without. Young people will be asked to complete an assessment battery developed in the first Work Package of this research programme. A longitudinal cohort study will be used to follow-up, at 6 and 12 months, the young people identified with depression and/or anxiety. At 6 months, participants will complete a brief (much reduced) assessment battery remotely. At 12 months, participants will complete the full assessment battery, which they completed at baseline. Contingency plans are in place to allow remote data collection where needed. Experience sampling method (ESM) pilot: Six young people per country aged 15-24 years old will be invited to pilot the ESM study procedures. They will complete an ESM assessment (lasting no longer than 2 min), 5-8 times per day over 7 days, using a mobile phone application. They will be asked to attend a briefing session and will be invited to a brief call during the week to troubleshoot any problems and answer some debriefing questions after the 7 day ESM period. ESM study: The procedures and ESM assessment will be refined using findings from the pilot. Young people participating in the cross-sectional and longitudinal cohort study will be invited to take part in the ESM study. 30 participants per country from either age group with depression and/or anxiety, and 20 participants from either age group per country without. 30 young people per country with depression and/or anxiety will be asked to complete the ESM assessments again after 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Depression and anxiety symptom recovery measured using the Generalized Anxiety Disorder questionnaire (GAD-7) and the 8-item Patient Health Questionnaire (PHQ-8) scores at baseline and 12 months. Recovery is defined as no longer screening positive for depression and/or anxiety (scoring ≤9 at 12 months on the scale where the higher score was measured at baseline), or not recovered (scoring >9 at 12 months on the scale where the higher score was measured at baseline) |
| Secondary outcome measures | Current secondary outcome measures as of 17/10/2023: 1. Demographic information including current living situation, gender, age, education level, and history and family history of depression and anxiety measured using questionnaires at baseline, 12 and 24 months 2. Degree of distress measured using GAD-7 and PHQ-8 scores at baseline, 6, 12 and 24 months 3. Drug use measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and the Adapted Teen Addiction Severity Index (T-ASI) at baseline, 12 and 24 months 4. Life events measured using the adolescent appropriate life events scale at baseline, 6, 12 and 24 months 5. Quality of life measured using the Manchester Short Assessment of Quality of Life (MANSA) at baseline, 12 and 24 months 6. Coping style measured using the child’s coping strategy checklist at baseline, 12 and 24 months 7. Resilience measured using the Brief Resilience Scale (BRS) and the Connor-Davidson Resilience Scale (CD-RISC 25) at baseline, 12 and 24 months 8. Use of healthcare and other services measured using the Client Service Receipt Inventory (CSRI) at baseline, 6, 12 and 24 months 9. Social support measured using scale of perceived social support at baseline, 12 and 24 months 10. Social capital measured using Adapted Social Capital Assessment Tool (ASCAT) at baseline, 12 and 24 months 11. Sports activity measured using open/closed questions about sports activities including frequency of participation and the nature of these activities at baseline, 12 and 24 months 12. Arts activity measured using open/closed questions about arts activities including frequency of participation and the nature of these activities at baseline, 12 and 24 months 13. Internet use measured using question 59 from the adapted REACH study at baseline, 12 and 24 months 14. Current country situation measured using closed questions with responses on a Likert scale at 24 months 15. Online games and gambling behaviour using closed questions at 24 months _____ Previous secondary outcome measures: 1. Demographic information including current living situation, gender, age, education level, and history and family history of depression and anxiety measured using questionnaires at baseline 2. Degree of distress measured using GAD-7 and PHQ-8 scores at baseline, 6, and 12 months 3. Drug use measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and the Adapted Teen Addiction Severity Index (T-ASI) at baseline and 12 months 4. Life events measured using the adolescent appropriate life events scale at baseline, 6, and 12 months 5. Quality of life measured using the Manchester Short Assessment of Quality of Life (MANSA) at baseline and 12 months 6. Coping style measured using the child’s coping strategy checklist at baseline and 12 months 7. Resilience measured using the Brief Resilience Scale (BRS) and the Connor-Davidson Resilience Scale (CD-RISC 25) at baseline and 12 months 8. Use of healthcare and other services measured using the Client Service Receipt Inventory (CSRI) at baseline, 6, and 12 months 9. Social support measured using scale of perceived social support at baseline and 12 months 10. Social capital measured using Adapted Social Capital Assessment Tool (ASCAT) at baseline and 12 months 11. Sports activity measured using open/closed questions about sports activities including frequency of participation and the nature of these activities at baseline and 12 months 12. Arts activity measured using open/closed questions about arts activities including frequency of participation and the nature of these activities at baseline and 12 months 13. Internet use measured using question 59 from the adapted REACH study at baseline and 12 months |
| Overall study start date | 01/05/2020 |
| Overall study end date | 30/08/2024 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 2040 for cross-sectional and longitudinal cohort study (including 150 for ESM study), 18 for ESM pilot |
| Total final enrolment | 2405 |
| Participant inclusion criteria | 1. Aged either 15-16 years or 20-24 years 2. Capacity to provide informed consent (20-24 year olds) or capacity to provide assent and informed consent provided by parent/guardian (15-16 year olds only) 3. Live in the defined geographical area (within 50% poorest neighbourhoods in the city) |
| Participant exclusion criteria | 1. Known diagnosis of severe mental illness such as psychosis, bipolar disorder, or schizophrenia 2. Known diagnosis of cognitive impairment 3. Unable to provide informed consent 4. Unable to read or write |
| Recruitment start date | 01/04/2021 |
| Recruitment end date | 29/09/2022 |
Locations
Countries of recruitment
- Argentina
- Colombia
- Peru
Study participating centres
San Martín de Porres
Lima
-
Peru
Piso 4
Edificio Emilio Arango S.J.
Bogota
-
Colombia
Buenos Aires
-
Argentina
Sponsor information
University/education
Mile End Road
London
E1 4NS
England
United Kingdom
| Phone | +44 (0)20 7882 5555 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study team will ensure that the new knowledge obtained translates into improved health outcomes by communicating study findings to different target audiences including, but not restricted to, adolescents and young people, policymakers, service managers, NGOs, education, health and youth organisations, charities, and the public. Planned publication in open access in peer-reviewed journals and presentation of findings at national and international conferences. Through partnerships with community-based arts organisations in each city, the study team will also disseminate findings to a wider, non-academic audience, which will likely involve online materials and social media. This strategy will also be facilitated by the study website and study social media accounts on Twitter and Instagram. |
| IPD sharing plan | In-line with the MRC's requirement for timely data sharing, the study team will have exclusive use of the data for 12 months following completion of the study. During this time, requests for data can be made to Stefan Priebe (s.priebe@qmul.ac.uk) or Catherine Fung (c.fung@qmul.ac.uk) and in accordance with the PCTU data sharing policy, which will be published on the study website. Individuals wishing to access the data will need to sign a data sharing agreement, in accordance with QMUL and PCTU procedures. Data access will be considered by the PCTU Data Sharing Committee and individuals wishing to access the data will also be bound by the PCTU data sharing policy. Potentially identifiable data will be removed from the dataset and aggregated data used where possible. Consent from participants for data sharing will be obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.0 | 07/09/2020 | 04/01/2021 | No | Yes |
| Participant information sheet | version v1.0 | 07/09/2020 | 04/01/2021 | No | Yes |
| Participant information sheet | version v1.0 | 07/09/2020 | 04/01/2021 | No | Yes |
| Participant information sheet | version v1.0 | 07/09/2020 | 04/01/2021 | No | Yes |
| Participant information sheet | version v1.0 | 07/09/2020 | 04/01/2021 | No | Yes |
| Participant information sheet | version v1.0 | 07/09/2020 | 04/01/2021 | No | Yes |
| Protocol file | version v0.5 | 15/09/2020 | 04/01/2021 | No | No |
Additional files
- ISRCTN99961401_PROTOCOL_v0.5_15Sept2020.pdf
- Uploaded 04/01/2021
- ISRCTN99961401_PIS_CSS young adults_v1.0_07Sept2020.pdf
- Uploaded 04/01/2021
- ISRCTN99961401_PIS_ESM pilot adolescents_v1.0_07Sept2020.pdf
- Uploaded 04/01/2021
- ISRCTN99961401_PIS_ESM pilot young adults_v1.0_07Sept2020.pdf
- Uploaded 04/01/2021
- ISRCTN99961401_PIS_ESM young adults_v1.0_07Sept2020.pdf
- Uploaded 04/01/2021
- ISRCTN99961401_PIS_ESM adolescents_v1.0_07Sept2020.pdf
- Uploaded 04/01/2021
- ISRCTN99961401_PIS_CSS adolescents_v1.0_07Sept2020.pdf
- Uploaded 04/01/2021
Editorial Notes
17/10/2023: The following changes were made to the trial record:
1. The overall end date was changed from 29/02/2024 to 30/08/2024.
2. The secondary outcome measures were changed.
3. The plain English summary was updated to reflect these changes.
15/02/2023: The following updates have been made to the study record:
1. Total final enrolment added.
2. The recruitment end date has been changed from 01/02/2023 to 29/09/2022.
16/02/2021: The recruitment start date has been changed from 01/02/2021 to 01/04/2021.
04/01/2021: Uploaded protocol Version 0.5, 15 September 2020 (not peer reviewed). The participant information sheet has been uploaded.
16/12/2020: Trial’s existence confirmed by Queen Mary University of London.
