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

Abstract

Background ‘POD Adventures’ is a gamified problem-solving intervention delivered via 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 randomised controlled trial of POD Adventures when delivered online with telephone support from counsellors. Method We conducted a parallel, two-arm, individually randomised pilot-controlled trial with 11 secondary schools in Goa, India. Participants received either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes were assessed at two timepoints: baseline and 6 weeks post-randomisation. Results Seventy-nine classroom sensitisation sessions reaching a total of 1575 students were conducted. Ninety-two self-initiated study referrals (5.8%) were received, but only 11 participants enrolled in the study. No intervention arm participants completed the intervention. Outcomes at 6 weeks were not available for intervention arm participants (n = 5), and only four control arm participants completed outcomes. No qualitative interviews or participant satisfaction measures were completed because 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 showing 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.

Mental Health Issues Among School Children and Adolescents in India: A Systematic Review

“…The study aimed to identify original research about mental health issues among school children and adolescents aged 19 years and under in India from studies published predominantly between January 2013 and August 2023. To obtain relevant articles, our initial literature search yielded 358 articles, 31 of which were included in this systematic review, the characteristics of which are summarized in The systematic review includes 24 cross-sectional studies [19,20,23,24,[26][27][28][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44]46,47], two descriptive cross-section studies [17,18], two comparative cross-section studies [21,29], whereas one randomized control trial [22], one survey study [25], and one intervention study [45] respectively. This review had 30,970 participants, of which 14381 (46.43%) were male.…”

“…This review had 30,970 participants, of which 14381 (46.43%) were male. The overall mean age of the school children and adolescents was 14.58 years, with a standard deviation of 1.35 [22,24,[26][27][28][29][35][36][37][38]43,44]. As per participants' concern, the sample size for cross-section studies ranging from 150 to 6682 participants, 242-369 participants for descriptive cross-section studies [17,18] and 462-1000 participants for comparative crosssection studies [21,29], whereas in randomized control trials [22], survey study [25], and intervention study [45], number of participants were 11, 874, and 300 respectively.…”

“…The systematic review includes 24 cross-sectional studies [ 19 , 20 , 23 , 24 , 26 - 28 , 30 - 44 , 46 , 47 ], two descriptive cross-section studies [ 17 , 18 ], two comparative cross-section studies [ 21 , 29 ], whereas one randomized control trial [ 22 ], one survey study [ 25 ], and one intervention study [ 45 ] respectively. This review had 30,970 participants, of which 14381 (46.43%) were male.…”

“…Out of a total of 31 studies, the maximum number of studies, i.e., seven studies from Karnataka [ 26 , 27 , 33 , 36 , 41 , 44 , 45 ], three studies from Tamil Nadu [ 23 , 25 , 47 ], and Gujrat [ 33 , 35 , 40 ], two studies each from Delhi [ 17 , 46 ], Bihar [ 20 , 38 ], Assam [ 18 , 37 ], Uttarakhand [ 19 , 28 ], Pondicherry [ 29 , 42 ], and West Bengal [ 21 , 43 ], and rest of the studies one each from Uttar Pradesh [ 34 ], Haryana [ 31 ], Kerala [ 39 ], Rajasthan [ 30 ], Kashmir [ 24 ], and Goa [ 22 ]. These results highlight the range of research efforts in the states and territories mentioned, emphasizing their geographical diversity.…”

Effectiveness of e-health intervention using smart phone app to reduce anxiety & depressive symptoms among adolescents: A cluster randomized controlled trial. (Study Protocol- NCT05865834)

“…However, it mentioned that most studies were not powered with a limited sample size, hence there is insu cient evidence to conclude the effectiveness of the mhealth approach for improvement of mental issues in adolescents (11). Another study conducted in India to deliver mental health interventions to school going adolescents during the pandemic also reported inconclusive results due to massive attrition (12). Despite the large number of applications available, the evidence base is scarce, particularly for adolescents especially in Pakistan.…”