PRIDE - Pilot Trial of an Online Digital Problem-solving Intervention for School-going Adolescents in Goa, India
Condition: Mental Health Issue; Depression, Anxiety; Stress
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study is part of a Wellcome Trust-funded research programme in India called PRIDE
      (PRemIum for aDolEscents, 2016-2022) led by Principal Investigator Prof. Vikram Patel
      (Harvard Medical School). The programme aims to develop and evaluate a trans-diagnostic,
      stepped-care intervention targeting common mental health problems in school-going adolescents
      in India.

      The study is planned in the context of school closures and other COVID-19 mitigation
      strategies in India. We will undertake a pilot randomized controlled trial with the specific
      aims to

        -  assess the acceptability and feasibility of an online problem-solving intervention

        -  obtain effect size estimates for the online problem-solving intervention when compared
           to a usual care control condition

        -  assess process variables related to intervention and research procedures and thereby
           assist with planning for a future large-scale trial.
    

Detailed description: 
      BACKGROUND:

      PRIDE has been implemented in India to address the scarcity of evidence-based interventions
      for common adolescent mental health problems nationally and in low-resource settings more
      widely. The goal is to develop and evaluate a suite of scalable, transdiagnostic
      psychological interventions (i.e., suitable for a variety of mental health presentations)
      that can be delivered by non-specialist ('lay') counsellors in resource-poor school settings.
      It builds upon India's national initiative for adolescent health, launched in 2014, which
      emphasises mental health as a public health priority and schools as an important platform for
      youth-focused treatment delivery.

      The development of the PRIDE school-based intervention model has been founded on the
      principle of stepped care which reserves increasingly specialised, resource-intensive
      interventions for individuals who do not respond to simpler first-line treatments. Previous
      PRIDE studies (Parikh 2019, Michelson 2019, Michelson 2020) revealed a high demand for
      school-based psychological support among socially disadvantaged adolescents. A majority of
      these adolescents do not meet conventional clinical thresholds for mental disorder, but may
      still benefit from early intervention to mitigate risks for developing more severe and
      socially disabling mental health problems in the longer-term.

      Hence, the aim of the current study is to evaluate the effectiveness of an online
      'open-access' digital intervention for adolescents who have a felt need for psychological
      support irrespective of assessed psychopathology. Online delivery is necessary due to
      prevailing COVID-19 restrictions that include school closures and a shift to online schooling
      for the remainder of the academic year.

      SIGNIFICANCE:

      This study comprises one of the first online adolescent mental health trials in the context
      of the COVID-19 outbreak in India. The study will take an existing digital mental health
      intervention developed and evaluated by our group in India and repurpose this platform for
      online delivery.

      Problem solving was selected as the core intervention component based on global evidence for
      its generalised (i.e., transdiagnostic) benefits across diverse mental health presentations
      and its specific relevance to common stressors observed in the target population.

      The findings are likely to be generalisable to routine settings since the research will be
      implemented in government-aided secondary schools which cater to low-income communities.
      External validity will be further strengthened through idiographic outcome assessment
      alongside standardised assessment instruments, and broad eligibility criteria which do not
      exclude any specific mental health presentations.
    

Intervention name(s): POD Adventures
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention arm will receive information about local services/national helplines and a brief problem-solving intervention that is delivered through a smartphone app with telephone guidance from a lay counsellor. The intervention is grounded in stress-coping theory, with a technical focus on practical problem solving. The emphasis on problem solving reflects the primacy of psychosocial stressors in adolescent help-seeking. Moreover, problem-solving is among the most commonly used practice elements in evidence-based psychological interventions for children and adolescents globally.
The content of the app comprises two sections: 'Adventures' which teaches problem-solving concepts and methods through contextually-appropriate games; and 'My POD' which scaffolds the student through the application of step-by-step problem-solving procedures to their own prioritized problems.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A two-arm, individually randomized controlled trial with equal allocation of participants between arms.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: digital mental health intervention; adolescent mental health