A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial

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. Objective Our 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. Methods We 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. Results The 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. Conclusions This 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 Registration ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486 International Registered Report Identifier (IRRID) DERR1-10.2196/30339

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

“…The pilot protocol has been previously published. 27 Trial findings have been reported according to CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance) guidelines for trials, modified for COVID-19. 28 …”

A film-based intervention (Intinn) to enhance adolescent mental health literacy and well-being: multi-methods evaluation study

“…Evidence has shown that diverse types of mental health/well-being interventions can be effectively delivered in non-clinical based settings, such as schools, to address psychological symptoms before they become more severe (Benton et al , 2021; Gonsalves et al , 2021). Although there are numerous interventions available to implement in schools, there is variable evidence of acceptability or effectiveness (Das et al , 2016); however, creative, arts-based interventions for adolescents may be beneficial (Goodwin et al , 2021; Goodwin and Behan, 2023; Janoušková et al , 2017).…”