Improving adolescent mental health by reducing the impact of poverty
| ISRCTN | ISRCTN14601588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14601588 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | WT 221940/Z/20/Z |
| Sponsor | King's College London |
| Funder | Wellcome Trust |
- Submission date
- 26/04/2024
- Registration date
- 29/04/2024
- Last edited
- 30/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression and anxiety are the leading contributors to the global burden of disease among young people, and contribute significantly to suicide. Investing in the health and human capital of young people, 90% of whom live in low- and middle-income countries (LMICs), is critical for future generations, and a key driver of the future health and economic prosperity of LMICs. Yet, the evidence base for interventions that effectively prevent adolescent depression and anxiety is weak, particularly in LMICs. One major shortcoming is that interventions often fail to address socioeconomic adversities due to multidimensional poverty, which are powerful determinants of adolescent depression and anxiety. Some antipoverty interventions, such as cash transfers and economic empowerment, have shown modest benefits for reducing youth depression in LMICs. However, anti-poverty interventions on their own are likely to be insufficient to reduce depression and anxiety, as are psychosocial interventions alone in the context of extreme poverty. Evidence is lacking on the potential of combining the science of anti-poverty interventions and psychosocial interventions, including those specifically targeted at strengthening self-regulation, in order to prevent adolescent depression and anxiety. The aim of ALIVE is to conduct a pilot evaluation of an intervention that both addresses poverty and strengthens self-regulation among adolescents living in urban poverty.
Who can participate?
Non-depressed and non-anxious 13-15-year-old adolescents and their primary caregivers who live in multidimensional poverty in Bogotá (Colombia), Kathmandu (Nepal), and Cape Town (South Africa).
What does the study involve?
In each site, eight schools will be randomly selected, and a total of 30 adolescents and caregivers will be recruited in each school. The schools will be randomly allocated to receive one of four interventions: (i) self-regulation intervention (focused on learning to regulate emotions and thoughts, to set goals and to maintain goal-directed behaviour), (ii) economic intervention (focusing on gaining financial skills, learning more about education, and how to manage money, including receiving a monthly cash transfer), (iii) combined intervention (which includes elements of both self-regulation and economic interventions); (iv) control intervention (care as usual).
Each intervention will consist of 20 weekly 1.5- to 2-hour group sessions with adolescents, and 6 monthly group sessions with their caregivers, over a period of 4-6 months. Sessions will be delivered by lay facilitators, all with experience working with adolescents and recruited from similar communities to the participants.
Adolescents and caregivers will be assessed on key measures before the start of the intervention, and they will be followed up once the intervention is over, and again 6 and 12 months after that. The adolescents will be assessed on topics relating to mental wellbeing, emotion regulation, behavioural difficulties, hope, sleep and economic questions around education, aspirations and financial education. These will be assessed via questionnaires and neuropsychological tasks or games. Participants’ heart rate variability will also be measured. Caregivers’ questionnaires will cover topics such as mental wellbeing, parenting, service use and economic-related questions.
Interviews with adolescents, caregivers and intervention facilitators will also be conducted after the intervention is over to understand their experience of the interventions better, and to see how the interventions could be delivered in a better way.
What are the possible benefits and risks of participating?
There are some benefits to participating in the pilot cluster RCT, should participants be enrolled in the study after screening. Participants who are allocated to one of the three intervention arms will gain some level of self-regulation or financial skills, which will be beneficial for their mental health and in budgeting in future. Participation in the study will also contribute towards developing an intervention that is culturally adapted, appropriate and accepted by adolescents living in poverty.
There is a possibility of increased burden on participants who have to complete the questionnaires at the different timepoints during the study. The risk that adolescent or caregiver participants will experience psychological stress or discomfort during the intervention is low. Indeed, the interventions provided are preventive, and thus will be targeting adolescents who are not currently experiencing depressive or anxiety symptoms. However, adolescents and their caregivers are recruited because they live in areas with high levels of poverty, and thus it is possible that the contents covered in the interventions may trigger psychological stress or discomfort.
Where is the study run from?
Kings College London (KCL) (UK) is the lead institution, to which the two principal investigators are affiliated. Local researchers and data managers in charge of data collection, data curation and analysis will be based in Colombia (Innovation for Poverty Action (IPA) Colombia), Nepal (Transcultural Psychosocial Organization (TPO) Nepal) and South Africa (University of Cape Town).
Who is funding the study?
Wellcome Trust (221940/Z/20/Z)
When is the study starting and how long is it expected to run for?
March 2024 to December 2025
Who is the main contact?
Emily Garman (emily.garman@uct.ac.za) – ALIVE Scientific Coordinator
Contact information
Scientific, Principal investigator
46 Sawkins Road, Rondebosch
Cape Town
7700
South Africa
 ORCID ID |
0000-0002-5159-8220 |
|---|---|
| crick.lund@kcl.ac.uk |
Scientific, Principal investigator
Roerstraat 108 I
Amsterdam
1078 LT
Netherlands
| ORCID ID |
0000-0001-5925-8039 |
|---|---|
| mark.jordans@kcl.ac.uk |
Public, Scientific
46 Sawkins Road, Rondebosch
Cape Town
7700
South Africa
| ORCID ID |
0000-0002-8128-5997 |
|---|---|
| Phone | +27 216501095 |
| emily.garman@uct.ac.za |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot four-arm single-blind cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Improving adolescent mental health by reducing the impact of poverty: pilot cluster randomised controlled trial |
| Study acronym | ALIVE |
| Study objectives | The aim of this pilot cluster randomised controlled trial is to evaluate the feasibility, acceptability and cost of the ALIVE intervention(s), and to test the trial procedures and measures to inform a future fully powered multi-site trial. |
| Ethics approval(s) |
1. Approved 18/03/2024, King's College London Health Faculties Research Ethics Committee (5-11 Lavington Street, London, SE1 0NZ, United Kingdom; +44 (0)20 7836 5454; rec@kcl.ac.uk), ref: HR/DP-23/24-40543 2. Submitted 24/04/2024, Nepal Health Research Council, Ethical Review Board (Ramshah Path, PO Box 7626, Kathmandu, 44600, Nepal; +977-1-5354220; approval@nhrc.gov.np), ref: 167 / 2024 3. Submitted 24/04/2024, University of Cape Town's Health Sciences Human Research Ethics Committee (Old Main Building, Groote Schuur Hospital, Main Road, Observatory, Cape Town, 7935, South Africa; +27214066338; hrec-enquiries@uct.ac.za), ref: 315/2022 4. Approved 19/04/2024, IPA Institutional Review Board (1701 Rhode Island Ave NW, 3rd Floor, Washington, DC, 20036, United States of America; n/a; humansubjects@poverty-action.org), ref: 4062 |
| Health condition(s) or problem(s) studied | Prevention of depression and anxiety among at-risk adolescents living in poverty |
| Intervention | This is a pilot four-arm cluster randomised controlled trial, taking place in three sites: Bogotá (Colombia), Kathmandu (Nepal) and Cape Town (South Africa). Schools will be considered clusters, and in each site, two clusters will be randomly allocated to one of the four arms: (i) self-regulation intervention, (ii) economic intervention, (iii) combined (self-regulation + economic) intervention, and (iv) control group. Randomisation will be stratified by site and computerized using a computer-based pseudo-random number generator. Each cluster will comprise of approximately 30 adolescents and 30 caregivers. Each intervention consists of 20 weekly group sessions with adolescents, and 6 monthly group sessions with their caregivers, over a period of 4-6 months. Each group will comprise of 15 adolescents and 15 caregivers, respectively. Sessions in the self-regulation and economic interventions will last 1.5 hours, while sessions in the combined intervention will last 2 hours. Sessions will be delivered by lay facilitators, all with experience working with adolescents and recruited from similar communities to the participants. Participants will be assessed on key measures before the start of the intervention (T0), post-intervention (T1), 12-months post baseline (T2) and 18-month post baseline (T3). The self-regulation intervention will combine group physical activity with core active components that strengthen self-regulation, selected based on an extensive review of the literature assessing the effect of key intervention ingredients in preventing depression or anxiety among youth globally. The purpose of the self-regulation intervention for adolescents will be to strengthen self-regulation among adolescents living in circumstances of poverty, through the creation of safe spaces for youth to build strong social connections, learn and master new skills, and experience respite from adversity and stressors. This will be done by: (i) providing access to caring adults and a supportive peer group; (ii) building a positive self-concept by independently mastering challenging new tasks such as martial arts-based physical activity (Nepal), skateboarding (Colombia) and surfing (South Africa), and; (iii) offering relief from the stress caused by the adversity they experience daily. The caregiver part of the intervention will also cover elements of psychoeducation, parenting and communication techniques, and stress reduction, based on the Caregiver Support Intervention. The economic intervention will consist of three phases: (i) The first phase will focus on education specific to financial needs and wants and developing skills to improve short- and long-term handling of finances, for both caregivers and adolescents; (ii) the second phase will focus on exploring opportunities through bargaining/negotiation and finding solutions when possible; this builds on recent research that emphasises the interdependence of decision making within the household, and the importance of adolescent negotiation skills to elicit investments from their caregivers on their education and well-being; (iii) the third phase will focus on creating awareness around benefits, challenges and solutions for accessing education. Alongside the delivery of the intervention sessions, both adolescents and caregivers will receive 6 cash transfers delivered at regular intervals over the intervention period, which equate in each site to the country’s one-month’s average household income. In Nepal the cash transfers will consist of the equivalent of 27 GBP per month for the caregivers; 12 GBP per month for the adolescent, using a cash in hand approach. In Colombia the cash transfer will consist of the equivalent of 57 GBP in total per month, of which 38 GBP will go to the caregiver and 19 GBP to the adolescent, using bank transfer or instant digital mobile transfers. In South Africa, the equivalent of 44 GBP will go to the adolescent, and 88 GBP to the caregiver, using instant digital mobile transfers. The combined intervention combines the content of the self-regulation and economic interventions, but presented in a condensed format. The intervention also includes the cash transfers to the adolescent and caregivers, as well as a section to explore the connections between the economic and self-regulation contents of the intervention. The control arm will follow a ‘care as usual' approach, which means that there will be no active comparator condition. The reasons for this choice are: (1) this is a preventive intervention, not a clinical treatment (no adolescents scoring above a validated threshold of depression and anxiety will be included); (2) it is in line with a recently published decision framework for the selection of control condition in randomized controlled trials, considering the ALIVE interventions can be categorized as an early phase trial and as low-risk; (3) we want to compare our intervention arms with the reality of what adolescents currently receive in these communities; and (4) there is genuine equipoise about the effects of self-regulation intervention and economic interventions (including cash transfers) on the prevention of depression and anxiety. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The feasibility outcomes to determine progression to a full trial will be: |
| Key secondary outcome measure(s) |
Additional feasibility measures will be assessed to help adapt procedures where needed. These include: |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Carer, Learner/student |
|---|---|
| Age group | Mixed |
| Lower age limit | 13 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 1440 |
| Total final enrolment | 1170 |
| Key inclusion criteria | The inclusion criteria for the participants recruited in the pilot cluster RCT are as follows: 1. Adolescents 1.1. Aged 13-15 years at the time of the first assessment; 1.2. Fluent in the local language (Spanish in Colombia, Nepali in Nepal, and English in South Africa); 1.3. Living in high level of multidimensional poverty, defined: 1.3.1. In Colombia, as living in one of two districts categorised as multidimensionally poor by the National Statistics Office using the Multidimensional Poverty Index; 1.3.2. In South Africa, as attending schools from quintiles 1, 2 or 3, which are public schools that have been declared exempt from charging school fees based on the economic level of the surrounding community; 1.3.3. In Nepal, as screening positive on a self-developed poverty screener, developed using items from the Global Multidimensional Poverty Index and based on poverty assessment-related literature and expert consultations (since children attending public schools come from diverse backgrounds); 1.4. With symptom scores below thresholds for depression and anxiety using the validated Patient Health Questionnaire – Adolescent version PHQ-A (for depression) and Generalized Anxiety Disorder (GAD) (for anxiety) 1.5. Whose primary caregiver is enrolled in the study (in Colombia and South Africa). 2. Caregivers 2.1. Aged 18 years or more; with their consent to participate in the pilot cRCT; 2.2. Fluent in the local language (Spanish in Colombia, Nepali in Nepal, and English, isiXhosa or Afrikaans in South Africa); 2.3. Living in high level of multidimensional poverty, defined as (i) living in an area with reported high levels of multidimensional poverty (Colombia), (ii) their child attending a school from quintile 1, 2 or 3 (South Africa), (iii) their child screening positive on a self-developed screener (Nepal); 2.4. Their child (biological or foster) is enrolled in the study. |
| Key exclusion criteria | The exclusion criteria are: 1. Adolescents self-reporting suicidality (also referred to high suicide risk), defined as current suicidal ideation with intent or plans over the past month, or suicidal attempt during the past 3 months (Nepal) or lifetime suicidal attempt (Colombia and South Africa) 2. Adolescents or caregivers with a significant disability that impacts participation in intervention or assessments (that cannot be overcome with reasonable adjustments) 3. Unaccompanied minors, and adolescents who are married, due to challenges with legal consent of caregivers |
| Date of first enrolment | 19/04/2024 |
| Date of final enrolment | 11/05/2024 |
Locations
Countries of recruitment
- Colombia
- Nepal
- South Africa
Study participating centres
Kathmandu
44600
Nepal
Bogotá
Cl. 93 #11A 28
Colombia
Bogotá
Cl. 73 #22-49
Colombia
Cape Town
7700
South Africa
Cape Town
7945
South Africa
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | All data obtained via ODK, HRV Logger and the neuropsychological task applications will be anonymised by use of participant ID numbers. Audio-recordings of interviews, which contain identifiable data, will be destroyed as soon as the transcripts are finalised. Only the consent forms will be stored in an identifiable format. The link file, containing information on participants’ names and ID will be kept in a separate location beyond the completion of the research, to allow participants to potentially be part of future research activities linked to the ALIVE study. During data collection, anonymised data arising from the project may be shared and used among the partner institutions listed within the collaboration agreement. All data arising will be considered confidential, and will not be shared with external researchers without prior consent from all institutions. In that case, a data sharing agreement will need to be completed with the external researcher or institution before de-identified data are shared. All data obtained via ODK, HRV Logger and the neuropsychological task applications will be anonymised by use of participant ID numbers. Audio-recordings of interviews, which contain identifiable data, will be destroyed as soon as the transcripts are finalised. Only the consent forms will be stored in an identifiable format. The link file, containing information on participants’ names and ID will be kept in a separate location beyond the completion of the research, to allow participants to potentially be part of future research activities linked to the ALIVE study. During data collection, anonymised data arising from the project may be shared and used among the partner institutions listed within the collaboration agreement. All data arising will be considered confidential, and will not be shared with external researchers without prior consent from all institutions. In that case, a data sharing agreement will need to be completed with the external researcher or institution before de-identified data are shared. Following project completion, the datasets generated during the current study will be stored in a publicly available repository called King’s Open Research Data System (KORDS), a data repository which provides long-term storage and access for datasets (https://kcl.figshare.com/). The data will include an embargo of two years, after which the quantitative data will be openly available. Qualitative data will also be stored using KORDS, but will not be publicly available, and instead shared upon request. This is due to the sensitive and context-specific nature of qualitative data. Both data and the consent forms will be kept for at least 10 years. After 10 years, the principal investigators will, however, reconsider whether the data should be kept for longer, depending on the usefulness of the data to national or international researchers external to the ALIVE team at that time, keeping in mind the FAIR principles. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/09/2025 | 30/09/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Statistical Analysis Plan | 11/06/2025 | 11/06/2025 | No | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN14601588 SAP pilot RCT_FINAL_11 June 2025.pdf
- Statistical Analysis Plan
Editorial Notes
30/09/2025: Publication reference added.
26/09/2025: The completion date was changed from 30/11/2025 to 31/12/2025.
11/06/2025: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The statistical analysis plan was uploaded as an additional file.
26/04/2024: Trial's existence confirmed by King's College London.
