A pilot randomised controlled trial of a guided online problem-solving intervention delivered through smartphones for secondary school pupils during the COVID-19 pandemic in India: Study protocol.
Gonsalves PP., Sharma R., Hodgson ES., Bhat B., Jambhale A., Weiss HA., Fairburn CG., Cavanagh K., Cuijpers P., Michelson D., Patel V.
BACKGROUND: 'POD Adventures' is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomised controlled trial of a remotely-delivered version of the intervention in the context of COVID-19 restrictions. OBJECTIVE: The objectives are to assess the feasibility of research procedures and intervention delivery and generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. METHODS: We will conduct a parallel, two-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post-randomisation. RESULTS: The first participant was enrolled on January 28, 2021 and 6-week assessment completed on April 4, 2021. Due to a second wave of COVID-19 in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. CONCLUSIONS: This pilot trial will help with understanding the feasibility of implementing and evaluating a remotely-delivered, digital mental health intervention in a low-resource setting. The findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. CLINICALTRIAL: This pilot trial is registered with the National Institute of Health registry (www. clinicaltrials.gov), registration number NCT04672486, registered on December 17, 2020. INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/30339.