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 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.

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The authors describe the case of a middle-aged female who presented to the emergency department with exquisite right upper quadrant pain. Computed tomography scan of the abdomen revealed a hydropic gallbladder, confirmed with abdominal ultrasonography. The clinical presentation, imaging findings, and management of this interesting condition are discussed.

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.

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.

Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India.

INTRODUCTION: We evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems. METHODS: We conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents. RESULTS: Between 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001). CONCLUSION: A single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India. TRIAL REGISTRATION NUMBER: NCT03633916.

App-based guided problem-solving intervention for adolescent mental health: a pilot cohort study in Indian schools.

BACKGROUND: This paper describes the pilot evaluation of 'POD Adventures', a lay counsellor-guided problem-solving intervention delivered via a smartphone app in Indian secondary schools. OBJECTIVE: To test the feasibility and acceptability of POD Adventures for adolescents with a felt need for psychological support, and to explore the intervention's effects on self-reported mental health symptoms, prioritised problems, stress and well-being. METHODS: We used a mixed-methods pre-post cohort design. Participants were self-referred from grades 9-12 in two coeducational government-aided secondary schools in Goa, India. The intervention was delivered in two formats, 'mixed' (comprising individual and small group sessions) and 'group' (small group sessions only). FINDINGS: 248 participants enrolled in the study and 230 (92.7%) completed the intervention. Outcomes at 4 weeks showed significant improvements on all measures that were maintained at 12 weeks. Large effects were observed on problem severity scores (4 weeks, d=1.47; 12 weeks, d=1.53) while small to moderate effects were seen on mental health symptoms, stress and well-being. 22 students completed qualitative interviews about their experience of the intervention. Participants found POD Adventures easy to use, engaging and helpful in solving their problems. They were satisfied with the guidance provided by the counsellor irrespective of delivery format. CONCLUSIONS: POD Adventures was feasible to deliver with guidance from lay counsellors in Indian schools, acceptable to participants and associated with large improvements in problem severity and mental health symptom severity. CLINICAL IMPLICATIONS: POD Adventures has promise as an early intervention for adolescents with a felt need for psychological support in low-resource settings.

Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial.

BACKGROUND: Mental health problems are a leading cause of disability in adolescents worldwide. Problem solving is a well-tested mental health intervention in many populations. We aimed to investigate the effectiveness of a brief, transdiagnostic problem-solving intervention for common adolescent mental health problems when delivered by non-specialist school counsellors in New Delhi, India. METHODS: This randomised trial was done in six government-run schools (three all-boys schools, two all-girls schools, and one co-educational school) that serve low-income communities. We recruited participants from grades 9 to 12 (ages 12-20 years) by selecting students with persistently elevated mental health symptoms accompanied by distress or functional impairment. Clinical eligibility criteria were assessed by research assistants using the Hindi-language version of the Strengths and Difficulties Questionnaire (SDQ), with reference to locally validated borderline cutoff scores of 19 or greater for boys and 20 or greater for girls on the SDQ Total Difficulties scale, an abnormal score of 2 or more on the SDQ Impact scale, and persistence of more than 1 month on the SDQ Chronicity index. Participants were randomly allocated (1:1) to problem solving delivered through a brief (2-3 week) counsellor-led intervention with supporting printed materials (intervention group), or problem solving delivered via printed booklets alone (control group). Primary outcomes were adolescent-reported mental health symptoms (SDQ Total Difficulties scale) and idiographic psychosocial problems (Youth Top Problems [YTP]) at 6 weeks. Primary analyses were done on an intention-to-treat basis at the 6-week endpoint. The trial is registered with ClinicalTrials.gov, NCT03630471. FINDINGS: Participants were enrolled between Aug 20, and Dec 4, 2018. 283 eligible adolescents were referred to the trial, and 251 (89%) of these were enrolled (mean age 15·61 years; 174 [69%] boys). 125 participants were allocated to each group (after accounting for one participant in the intervention group who withdrew consent after randomisation). Primary outcome data were available for 245 (98%) participants. At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61; p=0·0015). The mean SDQ Total Difficulties scores were 17·48 (5·45) in the intervention group and 18·33 (5·45) in the control group (-0·86, -2·14 to 0·41; 0·16, -0·09 to 0·41; p=0·18). We observed no adverse events. INTERPRETATION: A brief lay counsellor-delivered problem-solving intervention combined with printed booklets seemed to have a modest effect on psychosocial outcomes among adolescents with diverse mental health problems compared with problem-solving booklets alone. This counsellor-delivered intervention might be a suitable first-line intervention in a stepped care approach, which is being evaluated in ongoing studies. FUNDING: Wellcome Trust.

Development of a transdiagnostic, low-intensity, psychological intervention for common adolescent mental health problems in Indian secondary schools.

BACKGROUND: The PRIDE programme aims to establish a suite of transdiagnostic psychological interventions organised around a stepped care system in Indian secondary schools. This paper describes the development of a low-intensity, first-line component of the PRIDE model. METHOD: Contextual and global evidence informed an intervention 'blueprint' with problem solving as the primary practice element. Successive iterations were tested and modified across two pilot cohort studies (N = 45; N = 39). Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools. RESULTS: The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists. However, delivery was not feasible within the intended 6-week schedule, and participants struggled to use materials outside 'guidance' sessions. In Pilot 2, a modified counsellor-led problem-solving intervention was implemented by less experienced counsellors over a 3-4 week schedule. Outcomes were maintained, with indications of enhanced feasibility and acceptability. High demand was observed across both pilots, leading to more stringent eligibility criteria and a modified sensitisation plan. DISCUSSION: Findings have shaped a first-line intervention for common adolescent mental health problems in low-resource settings. A forthcoming randomised controlled trial will test its effectiveness.

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial.

BACKGROUND: Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial. METHODS/DESIGN: We will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding. DISCUSSION: Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems. TRIAL REGISTRATION: Both trials are registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration numbers NCT03633916 and NCT03630471 , registered on 16th August, 2018 and 14th August, 2018 respectively).

Design and Development of the "POD Adventures" Smartphone Game: A Blended Problem-Solving Intervention for Adolescent Mental Health in India.

Introduction: Digital technology platforms offer unparalleled opportunities to reach vulnerable adolescents at scale and overcome many barriers that exist around conventional service provision. This paper describes the design and development of POD Adventures, a blended problem-solving game-based intervention for adolescents with or at risk of anxiety, depression and conduct difficulties in India. This intervention was developed as part of the PRemIum for ADolEscents (PRIDE) research programme, which aims to establish a suite of transdiagnostic psychological interventions organized around a stepped care system in Indian secondary schools. Methods and Materials: Intervention development followed a person-centered approach consisting of four iterative activities: (i) review of recent context-specific evidence on mental health needs and preferences for the target population of school-going Indian adolescents, including a multiple stakeholder analysis of school counseling priorities and pilot studies of a brief problem-solving intervention; (ii) new focus group discussions with N = 46 student participants and N = 8 service providers; (iii) co-design workshops with N = 22 student participants and N = 8 service providers; and (iv) user-testing with N = 50 student participants. Participants were aged 12-17 years and recruited from local schools in New Delhi and Goa, including a subgroup with self-identified mental health needs (N = 6). Results: Formative data from existing primary sources, new focus groups and co-design workshops supported a blended format for delivering a brief problem-solving intervention, with counselors supporting use of a game-based app on "offline" smartphones. User-testing with prototypes identified a need for simplification of language, use of concrete examples of concepts and practice elements to enhance engagement. There were also indications that participants most valued relatability and interactivity within real-world stories with judicious support from an in-app guide. The final prototype comprised a set of interactive and gamified vignettes and a structured set of problem-solving questions to consolidate and generalize learning while encouraging real-world application. Discussion: Findings shaped the design of POD Adventures and its delivery as an open-access blended intervention for secondary school students with a felt need for psychological support, consistent with an early intervention paradigm. A randomized controlled trial is planned to evaluate processes and impacts of POD Adventures when delivered for help-seeking students in low-resource school settings.

What are young Indians saying about mental health? A content analysis of blogs on the It's Ok To Talk website.

OBJECTIVES: This study used thematic content analysis to examine submissions to a youth mental health website, www.itsoktotalk.in, in India. SETTING: We considered submissions made to the It's OK to Talk web platform during the first year of its operation (April 2017-March 2018), focusing specifically on website users based in India. PARTICIPANTS: We analysed 37 submissions by 33 authors aged 19-31 years (mean age 22 years) from seven Indian cities (New Delhi, Lucknow, Bengaluru, Mumbai, Pune, Hyderabad and Haryana). Eligible submissions were English-language first-person accounts of self-identified mental health problems, submitted in any media format for online publication by authors aged 18 years or older and who were based in India. Eight study participants were additionally involved in a focus group who contributed to the coding process and preparation of the final manuscript. RESULTS: Four themes were identified: (1) living through difficulties; (2) mental health in context; (3) managing one's mental health and (4) breaking stigma and sharing hope. Overall, the participants expressed significant feelings of distress and hopelessness as a result of their mental health problems; many described the context of their difficulties as resulting from personal histories or wider societal factors; a general lack of understanding about mental health; and widespread stigma and other negative attitudes. Most participants expressed a desire to overcome mental health prejudice and discrimination. CONCLUSIONS: Personal narratives offer a window into young people's self-identified priorities and challenges related to mental health problems and recovery. Such insights can inform antistigma initiatives and other public awareness activities around youth mental health.