Abstract
IMPORTANCE: Twelve million Indian adolescents live in slums, where access to mental health care is limited, a problem compounded by multiple stressors. The present trial seeks to address a critical gap in extant research involving community-based adolescent mental health care with a specific focus on low- and middle-income countries. OBJECTIVES: To assess whether a multimedia antistigma campaign can lower community stigma related to mental illness among adolescents and whether a primary care health worker-led digital intervention can reduce depression risk in adolescents living in slums in 2 Indian cities. DESIGN, SETTING, AND PARTICIPANTS: This was a parallel, cluster randomized, usual care-controlled trial conducted in 60 slums across New Delhi and Vijayawada from December 2022 to December 2023. Adolescents aged 10 to 19 years at high risk of depression (Patient Health Questionnaire-9 [PHQ-9] score ≥10), including depression, other significant emotional or medically unexplained complaints, and self-harm or suicide risk (hereafter, risk of depression or self-harm). Exclusion criteria included poor physical health that would prevent regular follow-up or temporary residence in the slums. The participants were recruited from the selected slum clusters via door-to-door screening by trained field facilitators. Slum clusters in each site were randomized to the 2 arms in a 1:1 allocation ratio using stratified randomization. Outcome data were collected by external data collectors blinded to the intervention. INTERVENTION: Multimedia antistigma campaign against stigma related to mental illness directed to adolescents and a primary care health worker-led digital intervention to identify and treat adolescents at high risk of depression or self-harm. MAIN OUTCOMES AND MEASURES: Coprimary outcomes included change in mean behavior scores of high- and low-risk cohorts at 12 months using the Knowledge, Attitude and Behavior scale and the proportion of adolescents at high risk of depression with remission at 12 months (defined as PHQ-9 score <5). RESULTS: Sixty slums participated, yielding a total study cohort of 3739 adolescents, 1761 (47.1%) of whom were at high risk of depression or self-harm (mean [SD] age, 14.3 [2.7] years; 2049 [55%] female). Implementation fidelity at 12 months was high-1667 of 1842 in the intervention cohort (90%) received all antistigma elements and 743 of 854 (87%) in the high-risk cohort were seen by primary care physicians. Mean (SE) behavior scores (assessed via anticipated behavior toward others with mental illness) were higher (suggestive of improvement) at 12 months in the intervention vs control clusters (17.22 [0.14] vs 16.44 [0.13]; mean difference, 0.78; 95% CI, 0.40 to 1.16; P < .001; standardized mean difference, 0.20). Among those at high risk of depression or self-harm, remission was higher at 12 months in the intervention vs control clusters, but the difference was nonsignificant (534/781 [model estimate, 68.2%] vs 461/833 [model estimate, 59.4%]; odds ratio, 1.47; 95% CI, 0.93-2.32; P = .10; risk difference, 0.07; 95% CI, -0.02 to 0.16). Mean (SE) PHQ-9 scores were lower (suggesting improvement) in intervention vs control at 12 months (4.05 [0.30] vs 4.92 [0.29]; mean difference, -0.87; 95% CI -1.66 to -0.08; P = .03; standardized mean difference, -0.18). CONCLUSIONS AND RELEVANCE: The findings demonstrate that the antistigma campaign positively impacted knowledge, attitude, and anticipated behavior related to mental health among adolescents and the model of training primary care professionals had a positive impact on mental health outcomes. TRIAL REGISTRATION: Clinical Trial Registry India: CTRI/2022/02/040307.