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BACKGROUND: Psychosocial interventions for adolescent mental health problems are effective, but evidence on their longer-term outcomes is scarce, especially in low-resource settings. We report on the 12-month sustained effectiveness and costs of scaling up a lay counselor-delivered, transdiagnostic problem-solving intervention for common adolescent mental health problems in low-income schools in New Delhi, India. METHODS AND FINDINGS: Participants in the original trial were 250 school-going adolescents (mean [M] age = 15.61 years, standard deviation [SD] = 1.68), including 174 (69.6%) who identified as male. Participants were recruited from 6 government schools over a period of 4 months (August 20 to December 14, 2018) and were selected on the basis of elevated mental health symptoms and distress/functional impairment. A 2-arm, randomized controlled trial design was used to examine the effectiveness of a lay counselor-delivered, problem-solving intervention (4 to 5 sessions over 3 weeks) with supporting printed booklets (intervention arm) in comparison with problem solving delivered via printed booklets alone (control arm), at the original endpoints of 6 and 12 weeks. The protocol was modified, as per the recommendation of the Trial Steering Committee, to include a post hoc extension of the follow-up period to 12 months. Primary outcomes were adolescent-reported psychosocial problems (Youth Top Problems [YTP]) and mental health symptoms (Strengths and Difficulties Questionnaire [SDQ] Total Difficulties scale). Other self-reported outcomes included SDQ subscales, perceived stress, well-being, and remission. The sustained effects of the intervention were estimated at the 12-month endpoint and over 12 months (the latter assumed a constant effect across 3 follow-up points) using a linear mixed model for repeated measures and involving complete case analysis. Sensitivity analyses examined the effect of missing data using multiple imputations. Costs were estimated for delivering the intervention during the trial and from modeling a scale-up scenario, using a retrospective ingredients approach. Out of the 250 original trial participants, 176 (70.4%) adolescents participated in the 12-month follow-up assessment. One adverse event was identified during follow-up and deemed unrelated to the intervention. Evidence was found for intervention effects on both SDQ Total Difficulties and YTP at 12 months (YTP: adjusted mean difference [AMD] = -0.75, 95% confidence interval [CI] = -1.47, -0.03, p = 0.04; SDQ Total Difficulties: AMD = -1.73, 95% CI = -3.47, 0.02, p = 0.05), with stronger effects over 12 months (YTP: AMD = -0.98, 95% CI = -1.51, -0.45, p < 0.001; SDQ Total Difficulties: AMD = -1.23, 95% CI = -2.37, -0.09; p = 0.03). There was also evidence for intervention effects on internalizing symptoms, impairment, perceived stress, and well-being over 12 months. The intervention effect was stable for most outcomes on sensitivity analyses adjusting for missing data; however, for SDQ Total Difficulties and impairment, the effect was slightly attenuated. The per-student cost of delivering the intervention during the trial was $3 United States dollars (USD; or $158 USD per case) and for scaling up the intervention in the modeled scenario was $4 USD (or $23 USD per case). The scaling up cost accounted for 0.4% of the per-student school budget in New Delhi. The main limitations of the studys methodology were the lack of sample size calculations powered for 12-month follow-up and the absence of cost-effectiveness analyses using the primary outcomes. CONCLUSIONS: In this study, we observed that a lay counselor-delivered, brief transdiagnostic problem-solving intervention had sustained effects on psychosocial problems and mental health symptoms over the 12-month follow-up period. Scaling up this resource-efficient intervention is an affordable policy goal for improving adolescents access to mental health care in low-resource settings. The findings need to be interpreted with caution, as this study was a post hoc extension, and thus, the sample size calculations did not take into account the relatively high attrition rate observed during the long-term follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT03630471.

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.

BackgroundThe 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.MethodContextual 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.ResultsThe 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.DiscussionFindings 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.

BackgroundConduct, 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/designWe 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.DiscussionBoth 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 registrationBoth 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).

Objectives: There is limited understanding of change processes and long‐term effects of low‐intensity psychosocial interventions. We investigated these aspects in two brief problem‐solving intervention formats for adolescents with elevated mental health symptoms and associated distress/impairment. Methods: This qualitative study was nested within a school‐based randomized controlled trial in New Delhi, India, which compared two problem‐solving intervention formats: a lay counsellor‐led format supported by printed materials (intervention arm) and printed problem‐solving materials alone ("bibliotherapy" control arm). A total of 32 participants, ranging in age from 14 to 20 years (mean = 16.4 years, SD = 1.9) and comprising 21 males and 11 females, were interviewed across both trial arms at 12‐month follow‐up. Results: Five themes were derived using thematic framework analysis. The "impacts on symptoms and functioning" theme described symptomatic improvements and functional gains. "Processes underlying problem solving" reflected changes in positive beliefs, attitudes and emotions when confronted with problems, and the use of a more effective problem‐solving coping style. "Experiences of problem‐solving materials" covered benefits (e.g. access to relatable stories and readymade solutions) and limitations (e.g. diminishing use over time) of printed problem‐solving handouts. "Role of supporting figures" accounted for the facilitating roles played by counsellors and trusted others. There were also accounts of researchers functioning as de facto counsellors in the bibliotherapy arm. "Recommended modifications for intervention delivery" included more flexible and private ways to access the interventions, greater personalization of the counselling process, more engaging and relevant supporting materials, and suggestions for widening access to the interventions in schools and community settings. Conclusions: We infer from our qualitative analysis that changes in problem‐solving style and problem orientation underpinned long‐term symptomatic and functional improvements. Participants in the counsellor‐led intervention appeared better able to sustain the use of problem‐solving skills and generalize this approach beyond the original presenting problems. We attribute the differences between arms to the influence of direct advice and supportive interactions with counsellors. Practice implications are discussed. [ABSTRACT FROM AUTHOR]

Background: The 'PRemIum for aDolEscents' (PRIDE) project has developed a school-based, transdiagnostic stepped care programme for common adolescent mental health problems in India. The programme comprises a brief problem-solving intervention ('Step 1') followed by a personalised cognitive-behavioural intervention ('Step 2') for participants who do not respond to the first step. Methods: A mixed-method design was used to evaluate the acceptability and feasibility of the stepped care programme in five schools in New Delhi. Participants were N = 80 adolescents (mean age = 15.3 years, females = 55%) with elevated mental symptoms and associated distress/impairment. Results: 61 (76%) of the enrolled sample were assessed following Step 1, from which 33 (54%) met non-remission criteria. Among these 33 non-remitted cases, 12 (36%) opted for Step 2 and five (42%) completed the full programme. The remaining non-remitted cases (n = 21, 64%) opted out of further treatment. Perceived resolution of the primary problem (n = 9, 43%) was the most common reason for opting out. The median time to complete each step was 22 and 70 days respectively, with a gap of 31 days between steps. Qualitative feedback from adolescents and counsellors indicated requirements for a shorter delivery schedule, greater continuity across steps and more collaborative decision-making. Conclusions: This study provides preliminary evidence for a stepped care programme aimed at common adolescent mental health problems. Modifications are recommended to enhance the acceptability and feasibility of the programme in low-resource settings. [ABSTRACT FROM AUTHOR]