Combining self-regulation and poverty reduction to prevent depression and anxiety among adolescents experiencing multi-dimensional poverty in Colombia, Nepal and South Africa: study protocol of a pilot 4-arm cluster randomised controlled trial.
Mark J D Jordans, Crick Lund, Emily C Garman, Manuel Seifert Bonifaz, Mauricio Avendano, Annette Bauer, María Cecilia Dedios Sanguineti, Georgia Eleftheriou, Sara Evans-Lacko, Sandra García Jaramillo, Juan Felipe García, Kamal Gautam, Martin Gevonden, Roxanne Jacobs, Brandon A Kohrt, Lydia Krabbendam, Nagendra P Luitel, Nicci van der Merwe, Juan Jose Castellanos Piedrahita, Rakesh Singh, Mohammadamin Sinichi, Daniela Trujillo, Katherine Sorsdahl, Sanchari Roy, Wietse A Tol, Daniela Rojas, Paula Yarrow
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引用次数: 0
Abstract
Background: Poverty is associated with depression and anxiety among adolescents, but evidence of interventions that prevent adolescent depression and anxiety among adolescents living in poverty is weak. Interventions either focus on reducing poverty or addressing depression and anxiety, but an approach that combines both may offer larger benefit. This multi-site parallel pilot cluster randomised controlled trial (cRCT) evaluates the feasibility and acceptability of a selective preventive intervention for depression and anxiety that simultaneously intervenes on both poverty and self-regulation among adolescents living in urban poverty.
Methods: The study takes place in Bogotá (Colombia), Kathmandu (Nepal) and Cape Town (South Africa). The pilot cRCT has four arms: (i) self-regulation intervention, (ii) economic intervention, (iii) combined (self-regulation + economic) intervention, and (iv) control group (care as usual). Interventions consist of 20 weekly group sessions with adolescents, and 6 monthly group sessions with their caregivers. The self-regulation intervention for adolescents includes psychological activities (mindfulness breathing, problem solving, biofeedback and goal setting) and a physical activity. The economic intervention includes three dimensions (financial training, negotiation training, education information) and a monthly cash transfer. In each site, the aim was to recruit 240 adolescents and their caregivers across eight schools (clusters), with two schools randomised to each arm. Adolescents residing in areas at risk of multidimensional poverty and who had symptoms of depression or anxiety, but who did not meet thresholds indicating depression and anxiety disorders, were considered for enrolment. Recruitment into the study is complete: a total of 628 adolescents and 536 caregivers were enrolled. Participants will be assessed four times: at enrolment, post-intervention and at 12 and 18 months post-enrolment. Primary outcomes include feasibility and acceptability criteria for study and intervention delivery procedures (i.e. randomisation, masking, recruitment, retention, missingness, fidelity, attendance, adverse events) defined as traffic light criteria to assess progression to an adequately powered trial. Secondary outcomes include self-report instruments, physiological measures and neuropsychological tasks.
Discussion: The effectiveness of combining self-regulation and anti-poverty interventions remains untested. This study will establish the feasibility and acceptability of delivering such an intervention, as well as test the trial procedures to inform a future adequately powered trial.
Trial registration: ISRCTN 14601588. Retrospectively registered. Date: 19 May 2024.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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