Evaluation of School-based Health Promotion Programmes in Bihar, India
Condition: Health Promotion
Study type: Interventional

Summary: 
      SEHER- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent
      health, seeks to develop and evaluate a school based adolescent health promotion intervention
      delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school
      counsellor called as SEHER Mitra (SM) in government-run secondary schools in Bihar, India.
      SEHER will implement a three armed clustered randomised trial (CRT) to evaluate the
      effectiveness and cost-effectiveness of these two models compared with the Tarang-Adolescence
      Education Programme (usual care) implemented by the State Government of Bihar. The hypothesis
      is that both interventions, compared to the control arm, will lead to a greater impact on
      school climate (school connectedness and relationship with teachers and fellow students). In
      addition, the interventions will increase the knowledge, attitude and awareness, and
      promoting healthy behaviours in youth on reproductive and sexual health outcomes, mental
      health and substance use, and gender related attitudes and violence. It is hypothesized that
      the addition of more resource intensive component (the SM arm) will be associated with the
      best outcomes.
    

Detailed description: 
      Background and objective:

      India is home to 358 million young people in the age group of 10 to 24; of these 243 million
      are between 10 and 19 years age. This represents a huge opportunity that can transform the
      social and economic fortunes of the country. Key public health challenges for adolescents in
      India include unwanted pregnancies, sexually transmitted and reproductive tract infections,
      injuries, growing misuse of alcohol, tobacco and other substances, and mental health problems
      such as depression, anxiety disorders and suicide. Schools provide an ideal platform for
      addressing these health issues and the WHO's Health Promoting Schools framework seeks to
      address some of the structural determinants of these health concerns. The recent Cochrane
      review assessed school-based interventions and found that 'whole school' or 'school
      environment' interventions are effective in addressing a range of health outcomes among
      adolescents including bullying, aggression, and tobacco use. However, there is no comparable
      evidence on effectiveness and cost-effectiveness on school-based health promotion programmes
      in India.

      SEHER-Strengthening Evidence base on school-based intErventions for pRomoting adolescent
      health, is a jointly funded programme (by The MacArthur Foundation and United Nation's
      Population Development Fund, India) that seeks to develop and evaluate a comprehensive
      adolescent health promotion intervention delivered by two different delivery agents viz.
      teacher as SEHER Mitra (TSM) and a lay health worker called as SEHER Mitra (SM) in government
      run secondary schools in Bihar, India.

      Hypotheses:

        1. For primary outcome measure: It is hypothesized that the intervention strategies in
           addition to usual intervention (Tarang-AEP) will have a graded effect on overall school
           climate.

        2. For secondary outcome measures: The interventions will build positive attitude towards
           gender equity, build knowledge of and attitude towards reproductive and sexual health,
           reduce self-reported bullying, violence and depression.

        3. For exploratory outcome measures : The interventions will decrease tobacco, alcohol and
           other substance use, reduce suicide behaviour (suicide thoughts and attempts) and
           increase safe sexual behaviour.

      An addition of the SEHER intervention with the already existing Tarang-AEP will enhance the
      effect on the above mentioned outcomes; low resource intensity intervention (Teacher-as-SEHER
      Mitra: Arm-I) having minimal to moderate effect, and the high resource intensity intervention
      (School Mitra: Arm-II) having the greatest and significant effect.

      Randomisation:

      The school as the unit of randomisation will be allocated to one of the intervention arms or
      comparison using minimisation during the pilot study (June 2014-March 2015). Although,
      usually a pilot study would be conducted in different schools from those in the main trial,
      it has been possible for SEHER to conduct the pilot study in the main trial schools because a
      new cohort of standard IX students will be entering school every year.

      Before randomisation, a list of eligible schools for randomisation (n=112) from the total
      number of secondary and higher secondary schools in Nalanda district of Bihar (n=136) was
      generated. The following criteria were used to generate the list: implementation of
      Tarang-AEP programme, total number of students in the school, and total number of employed
      teachers in school.

      Of the 112 schools, 75 were randomly selected for the random allocation. To have a
      representative pool of 75 schools, and to ensure an equal number of schools of each type in
      each of the three trial arms, 68 % of co-educational (63 out of 93), 69% of only girls' (9
      out of 13) and 50% only boys' schools (3 out of 6) were selected. All the 75 schools are
      allocated to comparison or one of the intervention arms by using minimization. To carry out
      the allocation by minimisation, the arms were balanced on the following variables (each of
      the variable will be classified into categories):

        1. Type of school (secondary= 1; and secondary and higher secondary school= 2);

        2. School size (small=100-300; medium=301-600, and large=601 and above students ), and

        3. Nature of school (Co-education=1; only boys'=2; and only girls' =3). The random
           allocation by using minimization was carried out by an independent statistician (Gian
           Luca DiTanna, LSHTM) using the R software package .

      Sample size:

      The sample size estimations are based on various scenarios for the changes in the primary and
      two secondary outcome measures, viz. overall school climate, self-reported bullying
      experience, and prevalence of moderate to severe depression, respectively. The baseline
      average score and prevalence rate/proportion of these outcome indicators and respective
      intra-class coefficients (ICCs)are based on the data collected during the pilot testing of
      the SEHER outcome assessment questionnaire in 15 schools (5 schools in each arm; N=1722
      participants).

        -  The arithmetic mean score on Beyond Blue School Climate scale is 20.7 (SD 6.7) with an
           ICC of 0.018. The minimum and maximum score on this 28 item scale range from 0 to 28,
           with higher scores indicating a more favourable experience of School Climate.

        -  18% students in secondary school in Nalanda, Bihar reported of experiencing bullying in
           last 30 days (In the last 30 days, I were made fun of with sexual jokes, comments, or
           gestures in the school) with an ICC of 0.03

        -  The arithmetic mean score on the Primary Health Questionnaire -9 (PHQ-9) is 6.12 (SD
           5.04) with an ICC of 0.0001

        -  The cluster number is 25 per arm and average cluster size is 200 (average classroom size
           in standard IX in schools in Nalanda district is 70 students with on average 3 divisions
           in each school)

        -  Assumed 15% loss to follow-up

      Based on these assumptions, the proposed trial will have 98% power to detect an effect size
      of 0.2 (difference in means/SD) average school climate score between the comparison and
      intervention arms, with 95% confidence and an ICC of 0.02 (88% power among boys and 93% among
      girls respectively).

      The trial will have 83% power to detect a 6% absolute difference in the proportion of
      students who reported of experiencing bullying between the comparison and intervention arms,
      with 95% confidence and an ICC of 0.03 (82% power to detect a 7% difference in boys and 83%
      power for a 6% difference in girls respectively). Likewise, the trial will have at least 93%
      power to detect an effect size of 0.1 in depression score overall, with 95% confidence and an
      ICC of 0.0001 (88% power among boys with an ICC of 0.03 and 92% among girls with an ICC of
      0.005 respectively).

      Process Evaluation: Process evaluation will be an integral part of the research design and
      will examine the quality of programme implementation (i.e. its integrity or fidelity), the
      completeness of its delivery, and the extent to which stakeholders engage with it. In doing
      so, it can help explain the programme's outcomes and identify ways to improve and/or
      replicate it. Two types of indicators will be collated to evaluate the fidelity of the
      delivery of the SEHER interventions, viz. their quantity and quality.

      Data management: Two types of quantitative data will be collected: intervention process, and
      outcome assessment. All outcome assessment data will be collected in paper form, as will
      process data from TSMs/SMs. All the data will be manually entered into Access database. Range
      and consistency checks will be performed at monthly intervals for all process data. Queries
      identified will be resolved promptly by the trial management team, and the database updated,
      maintaining the audit trail. All data will be kept in separate databases and only merged into
      a master database after data collection is completed and each individual database will be
      locked. All process data will be backed-up on external hard disks on monthly basis. Access to
      pre-locked data will be password protected at multiple levels and no member of the trial team
      apart from the data manager and independent statistician will have access to these passwords.
      After the dataset is locked, the dataset will remain password-protected and trial
      investigators will have access to the datasets. For all data, a separate file linking names
      and trial identification codes will be kept and password protected.

      Analysis:Quantitative analyses will be carried out using STATA (version 13). Below is a
      summary of our approach to the analysis. A detailed analysis plan will be agreed with the
      Data Safety and Monitoring Board towards the end of the trial and/or before any analysis is
      undertaken.

      Descriptive analyses: Initial analyses will compare characteristics of enrolled participants
      within and across arms (for example: age and socioeconomic background).An initial stage of
      statistical analysis will also involve examining the balance of characteristics within and
      across three arms of the outcome measures used in the SEHER study.

      The outcome measures will be summarised at baseline and follow-up by each cluster, arm-wise
      and overall. These will be summarised by means (SD), medians (Inter-Quartile Range) or
      numbers and proportions as appropriate by key relevant subgroups (such as age, gender, and
      baseline outcome score). For continuous outcomes, histograms will also be plotted within each
      arm to assess normality, and whether any transformation is required.

      Outcome analyses: The primary analyses, based on repeated cross sectional surveys, will be
      intention-to-treat at the end of the trial and using multi-level modelling to take into
      account clustering at the school level. The sub-group analysis will involve gender-wise as
      well as analyses with students who have at least 60% attendance in the academic year. The
      trial outcomes will be evaluated for the primary and secondary outcomes based on the change
      in the intervention arm compared to the change in the comparison relative to "baseline". The
      primary trial impact comparison will be analysed between the baseline assessment and the 6-7
      month follow-up assessment.

      Mixed effects regression will be performed to analyse changes in primary and secondary
      outcomes at school-level. The multilevel analyses will contain two levels: the school level
      and the individual student level. Effect sizes will be presented as risk ratios for binary
      outcomes (for e.g. experience of bullying), and as mean differences for continuous outcomes
      (for e.g. overall school climate score); 95% confidence intervals (CI) will be derived for
      both.

      The reporting and presentation of this trial will be in accordance with the CONSORT
      guidelines for cluster randomised trials, with the primary comparative analysis being
      conducted on an intention-to-treat basis.
    

Intervention name(s): Tarang Adolescence Education programme; SEHER Intervention
Intervention type(s): Other; Other
Intervention description(s): The comparison arm involves 'usual care' which in the study setting is the Tarang: Adolescence Education Programme comprising of 16 classroom sessions on process of growing-up, prevention of HIV/AIDS and other Sexually Transmitted Diseases (STDs), and prevention of substance and other drug abuse. This programme is delivered by a trained nodal teacher in the school over the academic year.; The SEHER intervention will be delivered by a trained teacher, called as Teacher-as-SEHER Mitra (Mitra meaning friend) or lay health worker called as SEHER Mitra being trained to facilitate following activities:
Awareness generation activities for all stakeholders in school
Wall-magazine
Speak-out box
Competitions
School Health Promotion Committee
School health policies
Peer groups of students of standard IX
Workshops and talks for all the students from standard IX, and for teachers
Counselling and referral services for all the students in the school This intervention will be delivered in each school over the academic year.
Other intervention name(s): TARANG-AEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other