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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	MR/S03580X/1
Sponsor	Queen Mary University of London
Funder	Medical Research Council

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Ms Catherine Fung
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
Email	c.fung@qmul.ac.uk

Prof Stefan Priebe
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
Email	s.priebe@qmul.ac.uk

Study information

Primary study design	Observational
Study design	Multi-centre cross-sectional study, longitudinal cohort study, and experience sampling method study
Secondary study design	Longitudinal study
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 objectives	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
Health condition(s) or problem(s) studied	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(s)	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)
Key secondary outcome measure(s)	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
Completion date	30/08/2024

Eligibility

Participant type(s)	Other
Age group	Mixed
Sex	All
Target sample size at registration	2058
Total final enrolment	2405
Key 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)
Key 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
Date of first enrolment	01/04/2021
Date of final enrolment	29/09/2022

Locations

Countries of recruitment

Argentina
Colombia
Peru

Study participating centres

Universidad Peruana Cayetano Heredia

Avenida Honorio Delgado 430 Urb. Ingeniería
San Martín de Porres
Lima
-
Peru

Pontificia Universidad Javeriana

Carrera 7 No. 40 - 62
Piso 4
Edificio Emilio Arango S.J.
Bogota
-
Colombia

Universidad Buenos Aires

Paraguay 2155
Buenos Aires
-
Argentina

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version v0.5	15/09/2020	04/01/2021	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.