Pilot randomised controlled trial of a remotely delivered online intervention for adolescent mental health problems in India: lessons learned about low acceptability and feasibility during the COVID-19 pandemic

Background “POD Adventures” is a gamified problem-solving intervention delivered via a smartphone app and supported by non-specialist counsellors for a target population of secondary school students in India during the COVID-19 pandemic. Aims To evaluate the feasibility and acceptability of undertaking a randomized controlled trial of POD Adventures when delivered online with telephone support from counsellors. Method We conducted a parallel, two-arm, individually randomized pilot-controlled trial with 11 secondary schools in Goa, India. Participants received either the POD Adventures intervention delivered over four weeks or usual care comprising information about local mental health services and national helplines. Outcomes were assessed at two timepoints: baseline and six weeks post randomization. Results 79 classroom sensitisation sessions reaching a total of 1575 students were conducted. 92 self-initiated study referrals (5.8%) were received, however only 11 participants enrolled in the study. No intervention arm participants completed the intervention. Outcomes at six weeks were not available for intervention arm participants (n=5) and only four control arm participants completed outcomes. No qualitative interviews or user satisfaction measures were completed as participants could not be reached by the study team. Conclusions Despite modifications to address barriers arising from COVID-19 restrictions, online delivery was not feasible in the study context. Low recruitment and missing feasibility and acceptability data make it difficult to draw conclusions about intervention engagement and indicative clinical outcomes. Prior findings that showed high uptake, adherence and engagement with POD Adventures when delivered in a school-based context suggest that an online study and delivery posed the biggest barriers to study participation and engagement.