Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02907125 |
| Other study ID # |
SANSEHER2016_0001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2016 |
| Est. completion date |
March 30, 2017 |
Study information
| Verified date |
May 2017 |
| Source |
Sangath |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
