Prevention of depression and anxiety among at-risk adolescents living in poverty Mental and Behavioural Disorders
Conditions
Interventions
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 i
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
13 Years to 100 Years
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility outcomes to determine progression to a full trial will be: 1.Feasibility of randomization using demographic information from the baseline assessment 2.Feasibility of data collection using proportion of missing items on the GAD-7 and PHQ-A items of the MMAPP instrument (described under future primary outcome measures) 3.Feasibility of masking of field workers using self-report questions added at the end of each assessment 4.Feasibility of retention using the proportion of recruited adolescents lost to follow-up at the 18-month post baseline follow-up 5.Fidelity of ALIVE interventions (all arms) across all sessions (average across intervention arms) based on observations of 10% sessions, assessed using self-developed instruments designed to assess the implementation of the intervention according to intervention protocols. 6.Adherence to intervention using session-by-session attendance, monitored using TeamPACT, a mobile app that can be used offline, which helps facilitators collect information on attendance, length of sessions, and allows facilitators to provide feedback on the sessions. 7.Reported (severe) adverse events reported during the ALIVE interventions (average across arms) compared to control 8.Safety of the cash transfer using post-session reports/feedback of any negative event due to cash transfer (e.g. theft, fights, arguments, drug use) Future primary outcome measure will be thMeasurement of Mental Health among Adolescents and Young People at the Population level Tool (MMAPP). The ALIVE version of the MMAPP tool includes 28 items, which allow to generate equivalency scores for the Patient Health Questionnaire (PHQ-9) Adolescent version (PHQ-A) and Generalised Anxiety Disorder Scale (GAD-7). The primary outcome will be defined as cumulative incidence of depression or anxiety over the 18-month follow-up period, as identified using validated cut-off scores on these instruments. That is, incidence will be defined as scoring above depre | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional feasibility measures will be assessed to help adapt procedures where needed. These include: 1. Feasibility of recruitment using 1.1. The proportion agreement to participate in the study using numbers screened, number of eligible participants, number invited to participate, consent rate (adolescents/caregivers), refusal rates. 1.2. The proportion of contamination using the responses to a question at the end of assessments asking participants if they had any contact with another participant from another arm/intervention (without disclosing information about the nature of the other intervention arms). 2. Competence of facilitators using the proportion of potentially harmful and proportion of adequate competency scores amongst intervention facilitators following observations using standardized tools. This will be assessed using an adapted version of the 13-item Working with Children Assessment of Competencies Tool (WeACT), and the 15-item Enhancing Assessment of Common Therapeutic factors (ENACT) instruments. 3. Acceptability of the intervention and study methods assessing whether the intervention and trial procedures are deemed acceptable to participants (via semi-structured interviews with adolescents and caregivers). Future secondary outcome or hypothesized mediator measures for adolescents will include (unless otherwise stated, all collected at all timepoints in all sites): 1. The Disruptive Behavior International Scale (DBIS) 2. The Identifying Depression Early in Adolescence Risk Score 3. The Difficulties in Emotion Regulation Scale – Short form 4. The Children’s Hope Scale 5. The Child and Youth Resilience Measure (in Nepal only) 6. Rugged Resilience Measure (in Nepal only) 7. Academic grades, school enrolment/education, aspirations and beliefs 8. Child labour 9. Questions relating to financial education and negotiation 10. The Client Service Receipt Inventory, adapted version (at T1, T2 and T3 assessments only) 11. Heart rate variability (HRV, | — |
Countries
Colombia, Nepal, South Africa
Contacts
Public ContactEmily Garman
Outcome results
None listed