Impact of a Classroom-based Sensitization Intervention on Demand for Mental Health Care Among Adolescents in India
Condition: Help-Seeking Behavior
Study type: Interventional

Summary: 
      The primary objective of this embedded stepped-wedge, cluster randomized controlled trial is
      to evaluate the impact of a classroom sensitization (intervention condition), over and above
      the school-level sensitization activities (control condition), on referrals to a host trial
      (examining the effectiveness of a problem-solving intervention delivered by lay counsellors).
      The primary hypothesis is that the classroom-level sensitization intervention will be
      associated with a higher overall referral rate into the host trial (i.e. the proportion of
      adolescents referred as a function of the total sampling frame in each condition). The
      secondary hypotheses are that, compared with the control condition, the intervention
      condition will be associated with a greater proportion of referred students who meet
      eligibility criteria for inclusion in the host trial and a greater proportion of students who
      self-refer. We will also explore whether there are any differences between conditions in
      terms of the severity of total symptoms and symptom subtypes presented by referred
      adolescents.
    

Detailed description: 
      Background and rationale:

      Schools are recommended as strategically important platform for improving young people's
      access to mental health care, including in low and middle- income countries (Patton et al.,
      2016). Along with a limited supply of effective treatments, low awareness about mental health
      problems and their treatment often act as barriers to help seeking in schools. Interventions
      to increase mental health literacy have been shown to increase the demand for mental health
      care among young people in a number of studies conducted worldwide, including in low-resource
      settings. However, the evidence is not conclusive as many of the existing studies are
      associated with a high risk of bias (Wei et al., 2013; Wei et al., 2015; Kutcher et al.,
      2016).

      Formative research in Government-run secondary schools in New Delhi, India indicated that
      mental health services were non-existent and adolescents had limited knowledge about mental
      health care. The investigators have therefore developed sensitization activities to promote
      referral to, and uptake of, a newly developed school counselling service. These sensitization
      activities have been designed for implementation at both whole school and classroom-levels,
      and are intended to be delivered by non-specialist counsellors. The additional resource
      investment in classroom-level sensitization activities may be justified if this component
      leads to significantly greater levels of demand. This trial therefore seeks to evaluate the
      additional impact of the classroom sensitization session on demand for school counselling in
      New Delhi.

      This study is part of a larger research program called PRIDE (PRemIum for aDolEscents). The
      overall goal is to develop and evaluate a trans-diagnostic, stepped-care intervention
      targeting common mental disorders in school-going adolescents in India. The PRIDE
      intervention architecture involves two sequential psychological treatments of incremental
      intensity. The first step is a brief problem-solving intervention delivered by lay
      counsellors. Adolescents with enduring mental health problems are referred to a higher
      intensity trans-diagnostic treatment delivered by psychologists.

      The trial described here is embedded within a host trial that is testing the effectiveness of
      the low-intensity problem-solving intervention. The embedded trial will evaluate the impact
      of the classroom sensitization activities over and above the school-level activities on
      referral rates generated for the host trial.

      Study design and setting:

      An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized
      controlled design in 70 classes across six Government-run secondary schools in New Delhi.

      Eligibility criteria: Please see section on eligibility.

      Interventions: Please see section on Intervention arms.

      Outcomes: Please see section on outcome measures.

      Trial scheme:

      The trial will be conducted over 12 weeks and recruit 70 classes. The referral outcomes for
      the students will be reported every four weeks across these classes. As each class has an
      average enrollment of 50, the study will follow around 3400 students for the entire trial
      duration of 12 weeks.

      Each class will switch over from the control condition to the intervention condition at
      4-week intervals (excluding holidays and exam breaks), over 2 steps. During the first 4-week
      period, only school-level sensitization activities will be implemented. In the next 4-week
      period (first step), 35 randomly selected classes (sequence 1) will receive the classroom
      sensitization intervention. In the final 4-week period (second step), the remaining 35
      classes (sequence 2) will receive the classroom sensitization intervention. Schedules for
      sensitization in the allocated classes will be shared with the schools in advance to ensure
      access.

      Power calculation:

      We based our power calculation on a within-period comparison for a stepped wedge design
      (Thompson et al., 2018) using Stata package "clustersampsi". Based on pilot data, we
      anticipated referral rates of 5% and 15% on the control and intervention conditions
      respectively, with an intra-cluster correlation coefficient (ICC) of 0.124. Using these
      parameters, a sample size of 70 classes (average class size of 50 students) will have 92%
      power to detect a difference of 10 percentage points (treating the outcome as a binomial
      variable), at a significance level of 0.05.

      Data collection:

      The primary outcome (referral rate) will be collated from referral logs maintained by
      researchers in each school. Referral data will be aggregated over each 4-week period.
      Secondary outcomes pertaining to the eligibility and clinical characteristics of students
      referred to the host trial will be derived from the Strengths and Difficulties Questionnaire
      (SDQ; Goodman et al., 2000).

      Statistical analysis:

      The baseline characteristics of the participating 70 classes, including class size and gender
      composition, will be described and assessed for any systematic differences across the two
      sequences. The primary outcome will be analyzed using generalized estimating equations (GEE)
      with robust standard errors. GEE is a recommended method for analysis of stepped-wedge
      cluster randomized controlled trials, providing population-averaged effects of exposure
      across trial conditions (Barker et al., 2016). GEE allows for longitudinal data analysis
      without resorting to fully specified random effect models and can be applied to both
      continuous and categorical outcomes (Liang and Zeger, 1986). It provides both parameter
      estimates and standard errors that are corrected for clustering of data and are consistent
      despite misspecifications in the correlation structure. For this trial, the clustering of
      data will be specified at the class level. Analysis of the secondary and exploratory outcomes
      will also be undertaken using the GEE method. Sensitivity analysis will be conducted using a
      'within-period comparison' of data from the second period only (Thompson et al., 2018). No
      interim analysis will be undertaken.

      Process evaluation:

      We will undertake descriptive analysis of quantitative process data in order to explore
      potential sources of variation in the implementation of intervention procedures.
    

Intervention name(s): Classroom sensitization session; School-level sensitization activities
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A one-off classroom information and engagement session will be delivered in addition to school-level sensitization activities. Individual classroom sessions will be conducted by a 'lay' counsellor with support from a researcher.
The classroom session will start with a short animated video which provides age-appropriate information about types, causes, impacts and ways of coping with common mental health problems. The video will be followed by a guided group discussion, structured around a standardized script that builds on the topics covered in the video. In case of technical difficulties that may prevent the video from being shown, a flipchart based on still illustrations from the video will be used.
At the end of the session, students will be handed a self-referral form which includes normalizing information and question-based prompts to assist with self-identification of mental health problems.; The control condition intervention will comprise sensitization activities conducted at the whole school level. These activities will include:
Posters containing information about the school counselling program and referral pathways will be displayed in prominent locations at each school.
A drop-box for student self-referral slips will be set up in a prominent location at each school.
Information meetings with teachers and the principal will be conducted at each school from the beginning of the trial.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Stepped-wedge cluster randomized controlled trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: adolescents; urban; school; demand for mental health care