Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02484014 |
| Other study ID # |
SANSEHER2015_0001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2015 |
| Est. completion date |
March 2016 |
Study information
| Verified date |
September 2016 |
| Source |
Sangath |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Background and objective:
India is home to 358 million young people in the age group of 10 to 24Íž 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.
