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

Summary: 
      SEHER Plus- Strengthening Evidence base on scHool-based intErventions for pRomoting
      adolescent health, seeks to 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 Plus will be implemented in the same randomly assigned 74 schools wherein, the SEHER
      trial (ClinicalTrials.gov ID: NCT02484014)-a three armed clustered randomised trial (CRT) was
      implemented 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 SEHER trial hypothesised that both interventions, compared to the control arm, would lead
      to a greater impact on school climate (school connectedness and relationship with teachers
      and fellow students). In addition, the interventions would 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. The
      SEHER trial also hypothesized that the addition of more resource intensive component (the SM
      arm) would be associated with the best outcomes. The hypothesis for the SEHER Plus is that
      students who will have exposure to the SEHER intervention activities in two academic years
      (Class IX and X) will show greater benefits on the primary, secondary and exploratory
      outcomes than students who have exposure to the SEHER intervention activities in one academic
      year (Class IX).
    

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 World Health
      Organization'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.

      Sangath has implemented SEHER-Strengthening Evidence base on school-based intErventions for
      pRomoting adolescent health (ClinicalTrials.gov ID: NCT02484014) , which 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. Following hypotheses are addressed through SEHER trial:

        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.

      Hypotheses for SEHER Plus:

      The SEHER Plus will address the additional benefits of providing an exposure to intervention
      activities for two years versus one year.

      For primary outcome measure: The students who will have exposure to the SEHER intervention
      activities in addition to the usual intervention (Tarang-AEP) in two academic years (Class IX
      and X) will show greater benefits on overall school climate than students who have exposure
      to the SEHER intervention activities and usual intervention (Tarang-AEP) in one academic year
      (Class IX).

      For secondary outcome measures: The students who will have exposure to the SEHER intervention
      activities in addition to the usual intervention (Tarang-AEP) in two academic years (Class IX
      and X) will show improved positive attitude towards gender equity, increased knowledge of and
      attitude towards reproductive and sexual health, reduced self-reported bullying, violence and
      depression than students who have exposure to the SEHER intervention activities and usual
      intervention (Tarang-AEP) in one academic year (Class IX).

      For secondary outcome measures: The students who will have exposure to the SEHER intervention
      activities in addition to the usual intervention (Tarang-AEP) in two academic years (Class IX
      and X) will report reduced incidence of tobacco, alcohol and other substance use, reduced
      incidence of self-reported suicide attempts and reduced incidence of sexual behaviour than
      students who have exposure to the SEHER intervention activities and usual intervention
      (Tarang-AEP) in one academic year (Class IX).

      The SEHER intervention with the already existing Tarang-AEP will enhance the effect on the
      above mentioned outcomes; the effects will be minimal to moderate among the students who have
      two years exposure and are from low resource intensity intervention (Teacher-as-SEHER Mitra:
      Arm-I), and the effects will be the greatest and significant among the students who have two
      years exposure and are from high resource intensity intervention (School Mitra: Arm-II).

      Randomisation: The school as the unit of randomisation are allocated to one of the
      intervention arms or comparison using minimisation during the pilot study of the SEHER
      project (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 .

      One school from the TSM arm dropped out after the pilot study and hence there are now 24
      schools in this arm.

      Sample size: All the students who are enrolled in class IX in the academic year March 2015-
      April 2016 and all the students who are enrolled in the class IX in the academic year March
      2016- April 2017 will be invited to participate in the outcome assessment to be completed in
      December 2016/January 2017.

      The investigators will not collect any baseline assessment for the students who are enrolled
      in Class IX in the academic year 2016-17. As part of the SEHER trial, the students who are
      enrolled in class IX in the academic year 2015-16 have participated in two outcome
      assessments; one in July 2015 and other in March/April 2016.

      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.

      Nested qualitative evaluation: A qualitative evaluation will be conducted at the end of the
      intervention to: a) explore deliverers' and recipients' responses to the intervention, and b)
      explore the school communities perception about the effect of the SEHER intervention on the
      students' health and academic attainment. The qualitative component will comprise of focus
      group discussions with single sex groups of class IX and X students, TSMs and SMs, and
      in-depth interviews with purposively selected male and female students from class IX and X
      who have availed counselling services, principals, Tarang nodal teachers and other teachers,
      TSMs/SMs and supervisors.

      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 14). Below is a
      summary of the investigator's 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 describe the characteristics of enrolled
      participants within and across arms (for example: age and socioeconomic background).

      The outcome measures will be summarised at end-line by each cluster, arm-wise and year-wise
      exposure, 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, and
      gender).

      Outcome analyses: The primary analyses, based on cross sectional survey, 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. Gender-wise sub-group analysis will be performed. 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. The primary trial impact
      comparison will be arm-wise analysed between the the students who have exposure to
      intervention activities for two academic years and the students who have exposure to
      intervention activities for one academic year.

      Mixed effects regression will be performed to analyse changes in primary and secondary
      outcomes at school-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): SEHER Intervention delivered by TSM; SEHER Intervention delivered by SM; Tarang AEP
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): SEHER Intervention 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 activitiesAwareness 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 class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.
This intervention will be delivered in each school over the academic year.; The SEHER intervention will be delivered by a 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 class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.
This intervention will be delivered in each school over the academic year.; 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.
Other intervention name(s): TSM Arm; SM arm; Comparison arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other