Effectiveness of a Problem-solving Intervention for Common Adolescent Mental Health Problems in India
Condition: Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
MeSH terms: Substance-Related Disorders; Personality Disorders
Study type: Interventional

Summary: 
      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 difficulties and associated impact. Participants will
      receive either a brief problem-solving intervention delivered by lay counsellors
      (intervention), or enhanced usual care comprised of problem-solving booklets (control).
      Self-reported adolescent mental health difficulties and idiographic problems will be assessed
      at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition,
      adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing
      and clinical remission, as well as parent-reported adolescent mental health difficulties and
      impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process
      evaluation, including estimations of the costs of delivering the interventions, will be
      conducted.
    

Detailed description: 
      Background and rationale:

      This study is part of a larger research program called PRIDE (PRemIum for aDolEscents) for
      which the goals are to:

        -  develop a trans-diagnostic, stepped-care intervention targeting common mental disorders
           in school-going adolescents in India; and

        -  evaluate its effectiveness in reducing symptom severity and improving recovery rates
           among adolescent participants

      The components of the stepped-care intervention will be evaluated in separate, linked
      studies. The main aim of the current trial is to evaluate the effectiveness of a
      low-intensity problem-solving intervention (the first step of the PRIDE stepped-care
      intervention) delivered by school counsellors for adolescents with common mental health
      problems, when compared with enhanced usual care (EUC).

      The primary hypothesis is that the intervention will be superior to the EUC control condition
      in reducing the severity of self-reported mental health symptoms and prioritized problems at
      six weeks post-randomization.

      Study design and setting:

      This is a parallel-arm, individually randomized controlled trial with equal allocation of
      participants between arms. The trial will be conducted in six Government-run secondary
      schools (Grade 9 to 12; approximately corresponding to 13-20 years of age) from the National
      Capital Territory of Delhi, India. A process evaluation will be nested in the trial to
      provide findings that will assist in the interpretation of the trial results and to inform
      potential implementation of the PRIDE intervention on a wider scale.

      Eligibility criteria: see 'Eligibility' section.

      Interventions: see 'Arms and Interventions' section.

      Screening measures: Referred adolescents will be screened for common mental health
      difficulties, impact and chronicity using the SDQ (Goodman et al., 2000), according to the
      eligibility criteria set out below.

      Sociodemographic information: This will be obtained from all enrolled participants through an
      interviewer-administered questionnaire, with responses entered directly into a tablet
      computer.

      Outcome measures: see 'Outcome Measures' section.

      Economic measures: The costs associated with the introduction of the experimental and control
      arm interventions will be estimated by adding the personnel costs for counsellors and
      supervisors, together with fixed costs of training (venue/per diem), furniture and supplies.
      All costs will be reported in Indian Rupees and then converted to US Dollars at the average
      daily exchange rate over the preceding 12 months.

      Process measures:

      Process data on enrollment, randomization and assessment procedures will be obtained from
      researcher-completed record forms. These will be collated to obtain assent/consent rates of
      adolescents and parents (and reasons for missing assent/consent); randomization rates (and
      reasons for randomization errors); completion rates of baseline and follow-up outcome
      assessments (and reasons for non-completion); and time lags between intended and completed
      assessments (and reasons for deviating from targets). In addition, motivations for
      help-seeking and expectancies for the school counselling program will be explored at the time
      of eligibility assessment through a brief qualitative interview with a sub-sample of referred
      students.

      Intervention processes will be assessed using additional data sources. Counsellor-completed
      session record forms will be used to obtain process data on duration, spacing and frequency
      of attended sessions (and reasons for non-attendance); and intervention uptake and completion
      rates (and reasons for pre-intervention and mid-intervention drop-out). Participants'
      adherence to treatment and potential engagement challenges will be assessed using checklists
      within the same record forms, indicating whether or not the student completed practice
      exercises at home, used the POD (Problems-Options-Do it yourself) booklets at home, brought
      the POD booklets to the session, and demonstrated understanding of POD booklets and session
      content. Use of POD booklets will be assessed in each arm of the trial at 6- and 12-week
      follow-up assessments using a brief adolescent-reported measure that asks about estimated
      frequency of home use and perceived helpfulness of POD booklets in the preceding 6 weeks.
      Service satisfaction data will also be obtained from participants in each trial arm at 12
      weeks using the 8-item Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979).
      Supplementary questions will elicit open-ended written feedback on the most helpful aspects
      of the available intervention and suggested modifications.

      Intervention fidelity will be assessed using independent ratings of audio-recorded sessions:
      10% of all recordings will be selected at random and rated by a psychologist who is not
      directly involved with supervision of the intervention providers.

      Sample size:

      Sample size estimations have been produced for two co-primary outcomes: mental health
      symptoms (SDQ Total Difficulties score) and idiographic problems (YTP score). A Bonferroni
      correction has been used to adjust for multiple primary outcomes. Following pilot work that
      indicated large (uncontrolled) effect sizes, the investigators have conservatively assumed
      that the intervention will be associated with an effect size of 0.5 (difference in means/SD)
      on both the primary outcomes with 90% power at 6 weeks post-randomization. The investigators
      have also assumed a loss to follow up of 15% over 6 weeks, based on pilot work. Based on
      these assumptions and a 1:1 allocation ratio for individual randomization, a total of 240
      participants will be required. This sample size provides 80% power to detect an ES of 0.44.

      Recruitment methods and sampling frame:

      A combination of whole-school and classroom-based sensitization methods will be used to
      generate referrals into the trial. This will include posters, teacher briefings and
      classroom-based information sessions for students. Referrals may be initiated in a number of
      ways: (1) adolescents can directly approach a researcher following a classroom information
      session; (2) adolescents can provide their contact details in a 'drop box' placed in the
      school; or (3) adolescents can request a referral through a teacher (or a teacher may raise
      the prospect of referral directly with a student before initiating the same). Referred
      participants will be assessed for eligibility using the SDQ; those meeting eligibility
      criteria will be invited to participate in the trial. Referred adolescents who do not meet
      eligibility criteria will receive a handout on self-care strategies.

      In the academic year 2018-19, there are 172 class divisions of grades 9-12 in the six
      collaborating schools in New Delhi, and approximately 50 students per class. Seventy classes
      will participate in an embedded recruitment trial (see separate protocol: NCT03633916). The
      host intervention trial will recruit participants originating from the 70 classes sampled in
      the embedded recruitment trial, as well as participants drawn from other classes as needed.
      The precise schedule of recruitment activities in the remaining 102 classes will be
      calibrated according to referral patterns and caseload capacity for intervention providers in
      the various schools.

      Assent/consent procedures:

      Referred adolescents will be invited to meet with a researcher when a 2-stage consent process
      will be initiated.

        1. Assent/consent for using screening data: All referred students who are screened for
           eligibility will be provided with written information and structured verbal information
           about the potential use of their screening data for evaluation of help-seeking patterns.
           Assent, consent will be obtained on signed consent forms.

        2. Assent/consent for trial participation: Eligible students will be provided with
           additional structured verbal information and a printed participant information sheet
           about trial participation. Assent will be sought for adolescents who are below 18 years
           of age, and consent will be sought for adolescents who are 18 years of age or older. For
           assenting participants aged below 18 years of age, consent from a parent/guardian will
           be sought by a researcher. This will involve two levels of consent: consent for their
           child to participate in the trial, and consent for a parent's/guardian's own
           participation in the study. The informed assent/consent procedure with adolescents will
           be completed during school hours, while the parent/guardian consent process will be
           completed at the family's home or another convenient location. Details of
           assenting/consenting adolescents and consenting parents (and those declining to
           participate) will be logged on an ongoing basis, along with reasons for
           non-participation.

      Data collection procedures (see 'Outcome Measures' for detailed descriptions of measures
      referenced below):

      Field researchers will administer outcome measures in schools, at home or other convenient
      locations. The adolescent-reported SDQ will be collected by a field researcher on a digital
      tablet device, and will also serve as the basis for eligibility screening. Other baseline
      assessments will be completed as soon as possible after assent/consent procedures are
      completed (and ideally on the same day). The YTP will be administered on paper while the
      remaining scales will be administered on a digital tablet device. The YTP will be
      administered on paper as it asks the participants to describe, prioritize and score their
      three main problems; the same list of problems will be rated again during follow-up
      assessments (see below). Adolescents will also be assessed on the PSS-4 and SWEMWBS. Index
      parents will be invited to complete the SDQ only. Sociodemographic data from the adolescent
      and parent/guardian will also be collected on digital tablets.

      Follow-up assessments will be completed at 6 and 12 weeks post-randomization. The 6-week
      outcome is the primary end-point, as the optimal effect of the intervention is expected to
      occur immediately after the intervention has been completed. The 12-week end-point is
      included to evaluate the durability of intervention effects. The CSQ-8 (a process measure of
      service satisfaction) will be collected at 12 weeks post-randomization only. Additionally,
      all adolescents will complete a self-report measure on the use of the intervention materials
      (problem-solving booklets) provided in the intervention and control arms.

      Data analysis plan:

      Descriptive analyses: Initial analyses will compare baseline characteristics of referred
      adolescents who did and did were not enrolled into the trial for various reasons. Baseline
      characteristics of enrolled participants will be compared between trial arms. Findings will
      be reported as per the CONSORT guidelines, using intention-to-treat analysis, including a
      trial flow chart.

      Outcome measures will be summarized at recruitment, at 6- and 12-week follow up by trial arm,
      and overall. These will be summarized by means (standard deviation), medians (interquartile
      range), or numbers and proportions as appropriate. For continuous outcomes, histograms will
      also be plotted within each arm to assess how closely the scales follow a normal
      distribution. This will determine how the outcomes are described as well as the choice of
      inferential analysis method.

      Outcome analyses: The primary analyses will be on an intention-to-treat basis at the 6-week
      end-point, adjusted for baseline values of the outcome measure; school (as a fixed effect in
      the analysis) to allow for within-school clustering, counsellor variation (as a random
      effect); and variables for which randomization did not achieve reasonable balance between the
      arms at baseline, or those associated with missing outcome data. Intervention effects will be
      presented as adjusted mean differences and effect sizes (ES), defined as standardized mean
      differences.

      For continuous variables, the analysis of secondary and exploratory outcomes will use similar
      methods to the primary outcome analysis for continuous variables. For the binary outcome
      (remission), the intervention effect will be reported as the adjusted odds ratio with 95%
      CIs. Generalized (linear or logistic) random-effects regression models will be used,
      adjusting for baseline outcome score and clustering, and other baseline variables as above.
      For outcomes to be examined over the 12-week follow-up period (other than remission),
      regression models will include a variable to represent 'time' in order to indicate whether
      the data were collected at the 6- or 12-week end-point. To assess whether the intervention
      effect varies over time, an intervention x time interaction term will be fitted to allow for
      a different intervention effect at 6 vs 12 months, although this will not be highly powered.

      We will explore potential moderators of intervention effects, with respect to a priori
      defined modifiers (i.e. chronicity of mental health difficulties, severity of mental health
      difficulties, YTP type, SDQ caseness profile). We will fit relevant interaction terms and
      test for heterogeneity of intervention effects in regression models. A mediation analysis
      will be conducted to examine whether the theoretically-driven a priori factor (perceived
      stress at 6 weeks) mediates the effects of the intervention on primary outcomes (i.e. mental
      health symptoms and idiographic problems) at 12 weeks. Additionally, intervention effects for
      students who receive fewer sessions than prescribed will be estimated using the Complier
      Average Causal Effect structural equation model.

      Process evaluation: We will undertake descriptive statistical analysis of quantitative
      process data in order to explore the implementation of intervention procedures. In addition,
      thematic analysis will be used to code and organise qualitative interview data on
      intervention expectancies (assessed prior to enrolment) and qualitative written feedback on
      service satisfaction (assessed at 12-week follow-up). Findings from the various data sources
      will be triangulated and used to develop explanatory hypotheses about potential differences
      in intervention delivery and engagement across schools, subgroups of participants and
      providers. Process evaluation findings will be used to facilitate interpretation of the main
      trial results. The trial statisticians may conduct further analyses to test hypotheses
      generated from integration of the process evaluation and trial outcome data.

      Cost-effectiveness analysis: The costs associated with the introduction of the PRIDE and
      control arm interventions will be estimated by adding the fixed costs of materials and
      personnel costs.
    

Intervention name(s): PRIDE 'Step 1' problem-solving intervention; Enhanced usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The PRIDE problem-solving intervention is one component of the PRIDE stepped care treatment architecture which comprises two sequential treatments of incremental intensity. 'Step 1' is a brief, first-line treatment. It is grounded in stress-coping theory, with a technical focus on practical problem-solving to modify developmentally salient stressors.
Step 1 has been designed as a 'low-intensity' intervention requiring fewer resources than conventional psychological treatments. This is achieved through a relatively brief delivery schedule (up to 5 x 20-30-minute sessions spread over approximately 3 weeks) and limited requirement for specialists. The delivery agents are lay counsellors receiving a combination of specialist and peer supervision. The counsellors offer guidance sessions to support the learning and implementation of problem-solving and complementary coping skills. Illustrated booklets are used to support learning of problem-solving concepts and skills practice at home.; There is no established mental health service provision in the collaborating schools. The control arm participants will receive an enhancement of this 'usual care' (essentially, no care) by having access to the same illustrated booklets used in the Intervention arm, albeit without any counsellor contact.
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: Adolescents