Abstract
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 randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions.ObjectiveOur objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial.MethodsWe will conduct a parallel, 2-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 randomization.ResultsThe first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments.ConclusionsThis pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our 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.Trial RegistrationClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486International Registered Report Identifier (IRRID)DERR1-10.2196/30339
Highlights
10%-20% of adolescents experience mental health conditions, but the majority of them do not seek help or receive care [1,2]
Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021
This paper describes the protocol for a pilot randomized controlled trial on POD Adventures delivered in an alternative internet-based format, necessitated by COVID-19–related school closures in 2020-2021
Summary
10%-20% of adolescents experience mental health conditions, but the majority of them do not seek help or receive care [1,2]. The pandemic has led to rapid and large-scale changes in service provision, in the transition to internet-based delivery of care [9,10]. Study (N=248), with findings suggesting that the intervention was acceptable, engaging, and feasible to deliver in school settings [18]. This paper describes the protocol for a pilot randomized controlled trial on POD Adventures delivered in an alternative internet-based format, necessitated by COVID-19–related school closures in 2020-2021. School disruptions led us to reposition the intervention on the internet and remotely delivered for students to use at home. The intervention maintains all elements of the pre-existing digital specification, modifications have been made for internet-based recruitment and remotely delivered guidance from counsellors (Multimedia Appendix 1). The specific objectives of this trial 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 for a full-scale trial
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