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Community youth teams facilitating
participatory adolescent groups, youth
leadership activities and livelihood
promotion to improve school attendance,
dietary diversity and mental health among
adolescent girls in rural eastern India:
protocol for a cluster-randomised
controlled trial
Suchitra Rath
1†
, Audrey Prost
2†
, Subhashree Samal
1
, Hemanta Pradhan
1
, Andrew Copas
2
, Sumitra Gagrai
1
,
Shibanand Rath
1
, Raj Kumar Gope
1
, Nirmala Nair
1
, Prasanta Tripathy
1
, Komal Bhatia
2
and Kelly Rose-Clarke
3*
Abstract
Background: Improving the health and development of adolescents aged 10–19 years is a global health priority. One
in five adolescents globally live in India. The Rashtriya Kishor Swasthya Karyakram (RKSK), India’s national adolescent
health strategy, recommends supporting community-based peer educators to conduct group meetings with boys and
girls. Groups aim to give adolescents a space to discuss the social and health issues affecting them and build their
capacity to become active community members and leaders. There have been no evaluations of the community
component of RKSK to date. In this protocol, we describe the evaluation of the Jharkhand Initiative for Adolescent
Health (JIAH), a community intervention aligned with RKSK and designed to improve school attendance, dietary
diversity and mental health among adolescent girls aged 10–19 years in rural Jharkhand, eastern India.
(Continued on next page)
© The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
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(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
* Correspondence: kelly.rose-clarke@kcl.ac.uk
†
Suchitra Rath and Audrey Prost contributed equally to this work.
†
Suchitra Rath and Audrey Prost are joint first authors.
3
Department of Global Health and Social Medicine, King’s College London,
Bush House NE Wing, London WC2B 4BG, UK
Full list of author information is available at the end of the article
Rath et al. Trials (2020) 21:52
https://doi.org/10.1186/s13063-019-3984-1
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
(Continued from previous page)
Methods: The JIAH intervention is delivered by a community youth team consisting of yuva saathis (friends of youth),
youth leadership facilitators and livelihood promoters. Teams conduct (a) peer-led Participatory Learning and Action
meetings with girls and boys, mobilising adolescents, parents, health workers, teachers and the wider community to
make changes for adolescent health and development; (b) group-based youth leadership activities to build
adolescents’confidence and resilience; and (c) livelihood promotion with adolescents and their families to provide
training and practical skills. We are evaluating the JIAH intervention through a parallel-group, two-arm, superiority,
cluster-randomised controlled trial. The unit of randomisation is a geographic cluster of ~1000 people. A total of 38
clusters covering an estimated population of 40,676 have been randomised to control or intervention arms. Nineteen
intervention clusters have adolescent groups, youth leadership activities and livelihood promotion. Nineteen control
clusters receive livelihood promotion only. Study participants are adolescent girls aged 10–19 years, married or
unmarried, in or out of school, living in the study area. Intervention activities are open to all adolescent boys and girls,
regardless of their participation in surveys. We will collect data through baseline and endline surveys. Primary trial
outcomes are school attendance, dietary diversity and internalising and externalising mental health problems.
Secondary outcomes include access to school-related entitlements, emotional or physical violence, self-efficacy and
resilience.
Trial registration: ISRCTN17206016. Registered on 27 June 2018.
Keywords: Adolescent, Nutrition, Mental health, Education, Participation, Participatory Learning and Action, Peer-led,
Youth leadership, Livelihood promotion
Background
The case for investing in adolescent health globally and
in India
Investing in adolescents aged 10–19 years is crucial for their
long-term health and well-being and could reduce the
inter-generational transmission of undernutrition, violence
and poverty [1]. Girls living in low- and middle-income
countries (LMICs) are particularly vulnerable due to sys-
tematic socio-economic and health disadvantages [2].
Twenty percent of the world’s adolescents live in India
[3], where gender inequalities persist across many health
and development indicators. One-fourth of girls com-
pared with 8% of boys aged 15–24 have never been to
school [4]. In addition, more than half of girls are an-
aemic, and 45% are underweight [5]. An estimated 7% of
girls aged 13–17 have a mental disorder [6]. Improving
the psychosocial well-being of adolescent girls in India is
thought to be a key strategy to improve their mental and
physical health [7]. There is increased recognition of the
need for holistic community approaches to adolescent
health that cut across multiple sectors, including educa-
tion, health, nutrition, and protection from violence. In
addition, there is growing appreciation that engaging
with both girls and boys to loosen the hegemonic gender
norms that constrain many adolescents is key to achiev-
ing long-term gender and health equity [8].
Evidence gaps
The Indian government’s 2014 adolescent health strat-
egy, the Rashtriya Kishor Swasthya Karyakram (RKSK),
takes a holistic approach to adolescent health promotion
[8]. It comprises facility- and community-based activities
with a focus on adolescent participation and leadership.
The community component involves adolescent groups
facilitated by peer educators and covering a broad cur-
riculum of health-related topics, including nutrition,
mental health, sexual and reproductive health, and vio-
lence. Peer education interventions are broadly defined
as interventions in which adolescent or young adult
facilitators seek to increase adolescents’knowledge or
influence their attitudes [9]. Interventions facilitated by
peers may have several advantages over those delivered
by adult providers. First, working with young laypersons
could reduce costs and thereby facilitate scale-up [10–
12]. Second, peer opinion strongly influences behaviours
in adolescence, and working with peers to shape norms
is now seen as essential to the success of adolescent
health campaigns [13]. Third, through their social net-
works, peers may be able to reach marginalised adoles-
cents who are not otherwise engaged in formal health or
education programmes.
Peer education interventions have been incorporated
into numerous national adolescent health strategies as
well as non-governmental programmes [14–17]. Some
have been tested in India [18]. The RKSK peer educator
curriculum has never been evaluated. Although some
RKSK activities have started, such as adolescent-friendly
clinics and the recruitment of peer educators, many evi-
dence gaps remained when the curriculum was launched.
What would adolescents and their families want from
such an intervention? Who should the peer educators be?
What kinds of activities should they perform to keep ado-
lescents engaged in meetings? What complementary
community-based activities are required to succeed in
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improving adolescent health and development? To answer
these questions, we conducted 18 months of formative
research aimed at optimising the Indian government’s
proposed community intervention with peer facilitators.
Formative research to develop a community adolescent
health intervention
We used the Medical Research Council framework for
the development and evaluation of complex interven-
tions to develop an intervention for adolescent health
and development in rural Jharkhand, eastern India [19].
We built on the Indian government’s proposal for peer
facilitators and adolescent groups, assuming that they
would eventually be implemented in our study area. Our
formative research included six main components:
1. A systematic review of the effects of peer-facilitated
interventions on adolescent health in LMICs [20]
2. A review of Indian and local adolescent health
initiatives
3. A baseline survey with data from 3324 adolescent
girls aged 10–19 to explore health and development
(including nutrition, education and psychosocial
well-being) across 50 villages in Jharkhand [21]
4. A survey of community resources for adolescents
(schools, youth clubs, sports teams and community
health services)
5. Thirteen focus group discussions with adolescent
girls and boys aged 10–19, and 15 interviews with
adolescents and frontline health workers
6. A community-based workshop with adolescents,
parents, teachers and local experts in adolescent
health and child protection, and a workshop with
ten experts in adolescent health in India, to
triangulate findings and gather ideas for the design
of specific components of the intervention
Our global systematic review found that peer-
facilitated interventions could be beneficial across a
range of areas of health, with the strongest evidence for
mental health [20]. Our review of Indian national and
local adolescent health programmes found that many
existed but had been designed and implemented by mul-
tiple governmental and non-governmental agencies,
resulting in a lack of coordination and overlap. In eastern
India in particular, there was discrepancy between planned
and actual coverage. Our baseline survey of 3324 girls
aged 10–19 years in 50 villages in Jharkhand provided
additional formative data [21]. We found substantial
school drop-out after the age of 15: less than half of girls
aged 15–19 were still in school. Girls left school because
they were required for work at home or on the family
farm or business. Around half of all girls were too short
for their age (height-for-age z score less than −2SD),
around 10% were too thin for their age (body mass index-
for-age z score less than −2 SD), and less than one-fourth
had received minimum dietary diversity in the last 24 h.
Violence, especially emotional violence, was common,
particularly among younger girls. Around one in ten girls
reported problems related to depression or anxiety. Girls’
most common self-reported health problems were high
fever and menstrual problems. Only 30% of girls aged
15–19 years had heard of contraception.
Participants in qualitative discussions described nu-
merous social, behavioural and environmental challenges
to adolescent health. Some, including lack of access to
health facilities, violence at home and in school, traffick-
ing and lack of livelihood opportunities, affected both
boys and girls. Others were more sex-specific: Alcohol
use was more common among boys, whereas girls were
exposed to sexual harassment (described as ‘eve-teas-
ing’), early marriage, early childbearing, and lack of
parental and financial support for secondary education.
Among all participants, there was a consensus that any
community intervention for adolescents should go be-
yond improving health and help adolescents gain educa-
tion and vocational skills. Adolescents, parents and
teachers indicated that information alone would not
engage adolescents and that groups should also be fun
and social. Local facilitators close in age to adolescent
group members, with engaging personalities and an in-
formal approach, could help make the groups more age-
appropriate, enjoyable and empowering.
Informed by findings from the reviews, survey and
qualitative study, we developed a community intervention
to be tested in a trial, building on the government-
supported peer facilitators. The intervention’s components
and working theory of change are described below.
Study aim
We aim to assess whether an intervention involving a
community youth team facilitating participatory peer-led
adolescent groups, youth leadership activities and liveli-
hood promotion can improve school attendance, nutrition
and mental health among adolescent girls in rural India.
Methods
Setting
The study is located in West Singhbhum, a largely rural
district in the eastern state of Jharkhand. West Singhbhum
has a population of 1,502,338 [22]. Sixty-seven percent of
its population belong to Scheduled Tribes who tend to
be socio-economically disadvantaged compared with
other demographic groups [22]. One-third of the popu-
lation are below the age of 15 [23]. Eighteen percent of
adolescent girls aged 10–19 cannot read, and a further
30% read with difficulty [21]. More than one-fifth of
girls aged 15–19 are married [21].
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The study is led by Ekjut (www.ekjutindia.org), a civil
society organisation, in collaboration with University
College London and the London School of Hygiene and
Tropical Medicine. Ekjut have been working in West
Singhbhum since 2004 to improve the health of women
and children in rural tribal communities.
Trial design
We are undertaking a parallel-group, two-arm, superior-
ity, cluster-randomised controlled trial with 1:1 alloca-
tion ratio and two cross-sectional surveys, one at
baseline and one at endline. The main trial analysis will
be a cross-sectional comparison of data from the endline
survey, adjusted for baseline differences. We chose this
approach in favour of a longitudinal design (i.e. only re-
interviewing baseline participants at endline), as we an-
ticipated that a large (potentially > 50%) proportion of
older adolescents (15–19 years) exposed to the interven-
tion would move out of the district or state for employ-
ment opportunities or marriage and thus would be lost
to follow-up with a longitudinal study design. We also
thought that matching participants between baseline and
endline would be challenging. Maximising our chances
of including older adolescents exposed to the interven-
tion was important, and the cross-sectional design
allowed us to interview older girls who had potentially
been exposed to the intervention.
The trial includes 38 clusters. Each cluster is a purpos-
ively selected geographic area with a population of
around 1000 people (between 723 and 1962), comprising
a village and its associated hamlets. Clusters are sepa-
rated by natural boundaries in order to minimise con-
tamination between intervention and control arms.
Randomisation
We conducted the randomisation on the 22nd of Febru-
ary 2017, allocating 19 clusters to the intervention arm
and 19 to the control arm. Clusters were stratified on
the basis of five strata: (1) clusters with a secondary
school and an adolescent club (clubs are community-
based health and development groups for adolescents
run by the Integrated Development Foundation), (2)
clusters with a secondary school and no adolescent
clubs, (3) clusters without a secondary school but with
an adolescent club, (4) clusters without a secondary
school and without an adolescent club, and (5) clusters
having a population of more than 1500. Figure 1de-
scribes the study profile. To ensure transparency of the
randomisation process, we invited participants from the
local community (village headmen, community health
Fig. 1 Trial design
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workers and a local government representative) to partici-
pate in the randomisation. We explained the intervention
and the purpose of randomisation to the participants.
Clusters were numbered and displayed on a wall. Identical
balls were numbered 1 to 38, representing each of the 38
clusters. For each of the five strata, participants placed the
numbered balls corresponding to the clusters in that strata
into a local tombola device. They operated the machine
and sequentially allocated each ball to the intervention
and control arms. Allocation was not concealed to partici-
pants present during the randomisation.
Trial participants and target population
All adolescent girls aged 10–19 years living in the 38
study clusters during the baseline and/or endline surveys
are eligible to participate in study interviews. Girls who
decline to be interviewed or who are living outside the
study clusters are excluded. Data from our baseline sur-
vey suggest that around 15% of adolescent girls may be
living outside the study clusters for reasons including
studying away from home and being employed outside
the village.
All adolescent boys and girls, aged 10–19 years, within
the study area (whether living there or not) are eligible
to participate in the intervention. Although, for financial
and logistical reasons, our trial outcomes relate only to
girls, we decided to include both boys and girls in the
intervention because the intervention activities were
relevant and potentially beneficial to boys and because
some health-related problems, such as gender-based vio-
lence, early marriage and sexual and reproductive health,
may be more effectively addressed by engaging with both
boys and girls. Participation in intervention activities is
voluntary, and adolescents are free to join or leave at
any time.
Intervention strategy
The intervention is a community youth team that de-
livers participatory adolescent groups, youth leadership
activities and livelihood promotion. Additional file 1
describes the intervention’s full theory of change. Add-
itional file 2is a short video clip with Ekjut team mem-
bers describing the intervention. Each cluster has a
community youth team delivering parallel intervention
activities. The team comprises a peer facilitator (yuva
saathi, meaning “friend of youth”) aged 20–25 years, a
youth leadership facilitator (one for six clusters), and a
livelihood promoter (one for ten clusters). The second
member of the community youth team is a youth leader-
ship facilitator who delivers fun, confidence-building
activities for adolescents every 2 months. Activities are
open to all girls and boys in the community and include
sports events such as football tournaments, archery and
run-a-thons, as well as problem-solving sessions and
nature walks. Both intervention and control clusters
have livelihood promoters, who are adults recruited for
their skills in farming and environmental management.
Livelihood promotion activities aim to provide adoles-
cents with practical skills which they can use in later life
and that improve food security for families.
The intervention engages and supports frontline health
care providers by inviting them to participate in adoles-
cent group meetings and facilitating referrals of adoles-
cents from the community youth teams to community
health services. An advisory committee involving repre-
sentatives from local governmental and non-governmental
adolescent services also advises and supports the commu-
nity youth teams on child protection issues and referral
services. We describe the community youth team’s
activities further below.
Yuva saathis and participatory adolescent groups
The main role of the yuva saathis is to facilitate monthly
participatory groups for adolescent girls and boys over a
period of 36 months. Ekjut recruited 30 yuva saathis (20
females and 10 males) in total. The recruitment process
involved a general knowledge test and face-to-face inter-
views with an assessed role-play. Yuva saathis were re-
cruited on the basis of their ability to speak both Hindi
and Ho (the most common local tribal language spoken
in the study area), their performance on a general know-
ledge test, and their ability to demonstrate confidence
and good communication skills during a face-to-face
interview. We chose to recruit yuva saathis aged 20–25
years because our formative research findings suggested
that adolescents preferred facilitators who were slightly
older than them, and parents, teachers and health
workers felt that facilitators in this age group would have
more confidence to facilitate meetings. Yuva saathis are
paid INR 5000 per month as an incentive and are
trained by members of the Ekjut team. They are su-
pervised by coordinators and supervisors who observe
approximately 20% of group meetings and meet with
yuva saathis fortnightly to debrief, troubleshoot and
plan future meetings. If yuva saathis have any con-
cerns about adolescents in their group, coordinators
and supervisors help them organise referrals to health
facilities or other services.
In each cluster, yuva saathis facilitate meetings which
are mainly held in community meeting spaces. The first
five meetings aim to introduce adolescents to the interven-
tion. Groups discuss social and economic influences on ad-
olescents’health, how to identify and involve vulnerable
adolescents in the intervention, gender norms and their
consequences, and the adolescents’own needs and ex-
pectations. These initial meetings are open to all com-
munity members, including adolescent girls and boys,
their parents, teachers and frontline health workers,
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and yuva saathis actively mobilise community members
to attend. All meetings involve participatory games and
open discussion.
After the first five meetings, the groups work through
four consecutive Participatory Learning and Action
(PLA) cycles. We chose to use a PLA approach for these
meetings because there was a consensus that building
adolescents’confidence and decision-making skills
would be desirable, and Ekjut has substantial experience
with this method. In earlier trials, PLA interventions en-
abled communities to improve the survival of newborn
infants, increase the dietary diversity of pregnant women
and young children, and reduce underweight in young
children [24–27]. PLA is now an approach used by the
India National Health Mission to conduct health-related
meetings in the community and may be extended to
peer facilitators of adolescent groups [28].
Each PLA cycle comprises five to seven meetings and
has four distinct phases: (1) identifying problems affect-
ing adolescents in the community (meeting 1), (2) iden-
tifying and deciding on strategies to address these
problems (meetings 2–3), (3) implementing the strat-
egies (meetings 4–6), and (4) evaluating the process
(meeting 7). The same yuva saathi facilitates each meet-
ing. There is a PLA cycle for each of the following four
themes: education, nutrition, health and violence. The
themes were selected on the basis of our formative re-
search and reflect the broad dimensions of adolescent
health and development as well as the RKSK curriculum.
At the start of each cycle, adolescents are given a choice
of meeting in single-sex or mixed groups. A discussion
is also held with local governance bodies, frontline
health workers and teachers to seek their ongoing con-
sent for the meetings, because topics (e.g., mental health,
violence or sexual and reproductive health) are consid-
ered sensitive. In the first phase of each PLA cycle, in
order to stimulate discussion, yuva saathis use picture
cards showing problems that adolescents might face.
Problems represented on the picture cards under each
theme are shown in Table 1and are standardised across
groups. Groups then vote on three problems that they
would like to address, and they select one or two for fur-
ther discussion. Problems mentioned by adolescents that
are not represented on the picture cards are written
down on blank cards and included in the voting exercise.
In the second phase of each cycle, yuva saathis use
stories based on prioritised problems to help groups
examine the causes of problems they identified in the
first phase. The stories prompt groups to consider
causes at the family, community and societal levels.
Groups decide which of these causes they would like to
address, develop appropriate strategies, and identify ways
to evaluate these strategies. In the third phase, groups
implement their chosen strategies. During this phase,
groups also participate in meetings to explore some of
the problems that were not prioritised but are consid-
ered relevant in light of the formative research. At the
start of each meeting in this phase, the group devotes
around 15 min to discuss and review their strategies,
challenges faced, and strategies for overcoming these
challenges. In the final phase, groups review their strat-
egies, any challenges they faced, and how these chal-
lenges were overcome. They also organise a community
meeting at the end of each PLA cycle, during which
groups share their experience and learning and seek sup-
port from the wider community. Strategies implemented
in earlier cycles continue to be implemented throughout
the intervention implementation period. A community
meeting is held at the end of each of the four thematic
PLA cycles, and an overall evaluation meeting to discuss
all strategies implemented and the way forward is also
held at the end of the intervention.
Through the PLA cycles, we expect groups across the
intervention arm to have devised and implemented a
wide range of strategies to address key health and devel-
opment problems affecting adolescents in their commu-
nities. The PLA cycles are expected to improve
adolescents’knowledge about health, education and nu-
trition (including services and entitlements), and gender
equity. Through the meetings, adolescents are expected
to gain confidence to share their needs and problems
Table 1 Problems represented on picture cards used in
Participatory Learning and Action cycles
Theme Problems represented on the picture cards
a
Education Gender norms related to education
School drop-out
Lack of access to school-related entitlements
Nutrition Anaemia
Lack of access to nutrition-related entitlements
Inadequate dietary intake and dietary diversity
Intra-household food distribution
Intra-household food insecurity
Health Lack of menstrual hygiene and menstrual disorders
Early marriage and adolescent pregnancy
Alcohol and substance abuse
Depression and anxiety
Behavioural disorders
Lack of access to health entitlements
Violence Street harassment
Physical and emotional violence
Sexual harassment
Not being able to voice their opinions
a
Problems mentioned by adolescents that are not on this list will be written
down on blank cards and included in the prioritisation exercise
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within the group, with their parents and peers, as well as
to improve their problem-solving skills and ability to ad-
dress issues related to their own health and development.
Marginalised adolescents, especially those who are out of
school, were identified during the five introductory meet-
ings and specifically encouraged to join the groups. PLA
cycles are also expected to have effects on adult members
of the community, including increasing their knowledge
about the health and development needs of adolescents,
motivating them to support the adolescent groups and
their strategies, and helping adults to recognise and appre-
ciate adolescents as citizens of the community with their
own rights and entitlements.
Youth leadership facilitators
Research from other settings in India suggests potential
benefits of combining peer-facilitated interventions with
complementary activities [18], and that developing ado-
lescents’self-efficacy and psychosocial resilience is a
‘missing piece’in improving girls’health [7]. Our forma-
tive research also indicated that adolescents would like
opportunities to participate in cultural and sports activ-
ities in their communities. On this basis, the community
youth team involves a youth leadership facilitator to de-
liver fun activities that build adolescents’confidence and
help to keep them engaged in the PLA cycle. These ac-
tivities are also an opportunity to provide information
related to adolescent health and development, and to
reach out to the rest of the community. Activities are open
to all girls and boys in the community and occur every 2
months. They run in parallel with the PLA cycle and in-
clude football tournaments and other sports activities,
problem management sessions, cycling sessions and na-
ture walks. Youth leadership facilitators are local adults re-
cruited by Ekjut on the basis of their leadership skills,
experience of working with young people, and under-
standing of the principles of PLA. Facilitators participate
in monthly meetings with yuva saathis, coordinators and
supervisors in order to coordinate and plan intervention
activities.
Livelihood promoters
Through our formative research, adolescents and their
parents informed us that they wanted opportunities to
participate in livelihood training to develop practical
skills related to farming and environmental manage-
ment. We therefore engaged livelihood promoters, who
are adults recruited for their skills and knowledge in
farming practices and environmental management, to
deliver a programme of livelihood promotion activities.
Activities reflect the seasons, are selected in consultation
with communities and include paddy cultivation, multi-
cropping, compost-making and other organic farming
techniques, tree planting, rainwater harvesting, and revival
of farmers and save the forest groups (van samitiy). Activ-
ities will run approximately every 3 months in both inter-
vention and control arms and are family-focused,
involving both adolescents and their parents. The
programme has three main aims: (1) to provide adoles-
cents with practical skills that they can use in later life; (2)
to improve food security for families, which will help to
improve dietary diversity; and (3) to provide a common
benefit to both intervention and control arms to help
build support for the research across the trial arms.
Trial timeline and status
The baseline survey was conducted between June 2016
and January 2017. In April and May 2017, we recruited
and trained the community youth teams. The interven-
tion will be implemented over 36 months from June
2017 to May 2020. The endline survey will partially
overlap with intervention implementation and will be
conducted between December 2019 and April 2020. A
time frame for the research activities is shown in Fig. 2.
Research questions
We seek to test the effects of the intervention on three
main outcomes: school attendance, dietary diversity and
mental health. We chose these to represent the broad
range of health and development issues affecting adoles-
cent girls in India and because formative research indi-
cated that these are important problems for girls in the
study area.
Primary research questions
What is the effect of an intervention comprising partici-
patory adolescent groups, youth leadership activities and
livelihood promotion, delivered by a community youth
team, on adolescent girls’school attendance, dietary di-
versity and mental health?
Secondary research questions
Secondary research questions explore intermediate ef-
fects of the intervention on the pathway to impact on
school attendance, dietary diversity and mental health.
We ask, does the intervention:
increase the uptake of school-related entitlements
(e.g., cash, bicycles, books, mid-day meals for girls in
upper primary, scholarships)?
reduce the number of girls who were absent from
school in the past 2 weeks?
increase adolescent girls’decision-making ability,
self-efficacy and resilience?
reduce the percentage of girls who drank alcohol in
the past month?
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increase the percentage of girls with attitudes
supportive of equitable gender norms related to
education and domestic work?
reduce exposure to emotional and physical violence and
increase the number of girls who intervene to reduce
emotional and physical violence against their peers?
Study outcomes
The trial has three primary outcomes: school attendance,
dietary diversity and mental health problems (Table 2).
We will assess the percentage of girls attending school
or college at the time of the endline survey. Information
on school attendance will be self-reported, and we will
cross-check answers in school registers for 10% of girls
randomly selected from the sample. We will use the
Food and Nutrition Technical Assistance tool to meas-
ure mean dietary diversity score (based on 24-h recall)
[19]. For mental health problems, we will compare the
mean score on the Brief Problem Monitor–Youth
(BPM-Y) across trial arms [20]. The BPM-Y includes
items on internalising (depression and anxiety), externa-
lising (conduct disorder and oppositional defiant dis-
order) and attention problems. Secondary outcomes on
the pathway to change for the primary outcomes are
outlined in Table 2and presented in the theory of change.
Tertiary outcomes are also shown in the theory of change
(Additional files 1and 3) and relate to further hypothe-
sised outcomes of the intervention that are not directly re-
lated to the primary outcomes. Additional file 3also
outlines how each outcome is measured and if baseline
data are available.
Sample size and power
The size of the study area, and hence the number of
clusters, was chosen for logistical reasons. With a
district-level crude birth rate of around 23 per 1000
population and accounting for child deaths, we expected
to find an estimated 8800 adolescents aged 10–19 (4400
girls) in our proposed intervention area. We anticipated
that in each cluster there would be ~115 adolescent girls
aged 10–19 years.
A total of 3324 adolescent girls aged 10–19 years par-
ticipated in the baseline survey: 82% of an estimated
4068 girls in the 38 clusters. The mean number of girls
in each cluster was 87 (SD, 29.9). We aim to interview
the same number of girls in the endline survey. With a
mean cluster size of 87, a coefficient of variation of clus-
ter sizes of 0.3 [29], and using intra-cluster correlation
coefficients (ICCs) from our baseline data, the trial will
have 80% power to detect a nine-percentage-point in-
crease in the proportion of girls attending school or col-
lege (ICC, 0.03), from a baseline prevalence of 69% to
78%; a 0.9-point increase in mean dietary diversity score
(ICC, 0.40), from a mean baseline score of 3.4 (SD, 1.4)
to 4.3; and a 2.7-point decrease in BPM-Y score (ICC,
0.39) from a mean baseline score of 6.0 (SD, 4.3) to 3.4.
The significance level is set at 0.05. We performed these
calculations in Stata software (version 14; StataCorp,
College Station, TX, USA). We anticipate that including
baseline data in our analysis will lead to gains in power
but do not attempt to quantify these here.
Data collection, cleaning and storage
In this section, we describe data collection processes for
the endline survey. These are identical to processes
followed at baseline, which are described elsewhere [21].
Twelve monitors who are independent from the com-
munity youth teams will undertake data collection. In
each of the study clusters, they will visit all households
in order to identify eligible adolescent girls. In
Fig. 2 Study timeline
Rath et al. Trials (2020) 21:52 Page 8 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
households with an eligible girl, monitors will explain
the study to the girl and seek her consent. For girls
under the age of 18, monitors will also seek consent
from the girl’s caregiver. The monitor will then find a
convenient time to conduct an interview with the girl in
her home (e.g., outside school hours for school-going
girls). If girls are not available when the monitor visits
the household, the reason for unavailability will be re-
corded. Through these interviews, we will collect data
relating to the primary and secondary outcomes, as well
as data on the socio-economic status of the household
and for the process evaluation. Data will be collected
using mobile phones programmed using the CommCare
data collection platform, which uses automated skip pat-
terns and in-built checking and consistency logic to sup-
port data validation. Data will be downloaded from the
server every 2 weeks. We will check the number of inter-
views completed and look for any problems. Every
month, we will check the data for outliers, errors and
missing data using automated do-files in Stata. The final
dataset will be stored on a password-protected hard
drive after removing individual identifying information.
Blinding
Data collection during the endline survey will overlap
with intervention activities by approximately 3 months.
Monitors will not be given information about the alloca-
tion of clusters. However, through their monitoring ac-
tivities in the villages, they may encounter some of the
intervention activities or meet members of the commu-
nity youth teams. Because of the participatory nature of
the intervention, adolescents and the community youth
teams cannot be blind to allocation. The researcher con-
ducting the final trial analyses will be blind to allocation.
Analyses for the primary outcomes will be repeated by
an independent statistician also blind to allocation.
Analysis plans
Primary analysis will employ an intention-to-treat ap-
proach, including all adolescent girls aged 10–19 living
in the study area, regardless of their level of participation
in the intervention activities. We have three primary
outcomes. We think that success in improving at least
one of these outcomes could help inform decisions
about future scale-up. We will declare the trial a success
if we find a significant (two-tailed P< 0.05) benefit for at
least one outcome in conjunction with a collectively
‘positive signal’for the other two outcomes. A ‘positive
signal’is defined as at least one of the two outcomes in
the direction of benefit, neither outcome showing signifi-
cant harm, and if for one outcome the direction of effect
is towards benefit and for the other it is towards harm,
then we require the (two-tailed test) Pvalue for the
former outcome to be smaller than that for the latter.
The type I error rate corresponding to this definition of
success varies according to the correlations between the
three outcomes, which we expect to be positive. Under
perfect positive correlations, the type I error rate is 5%.
Under independence and the null hypothesis (no inter-
vention effect on any outcome), the probability of
Table 2 Trial outcomes
Primary outcomes
1 Percentage of adolescent girls attending school or college
2 Mean dietary diversity score, based on 24-h recall
3 Mean score on the Brief Problem Monitor–Youth
Secondary outcomes
1 Percentage of girls making decisions independently and with
others about the food they eat, including how much they
eat and what types of food they eat
2 Mean score on gender role attitudes index
3 Percentage of girls making decisions independently and with
others about friends, spending money and purchases
4 Mean score on the Schwarzer General Self-Efficacy (GSE) Scale
5 Mean score on the Child and Youth Resilience Measure 11-item
version (CYRM-B)
6 Percentage of girls who report experiencing emotional violence
in the past 12 months
7 Percentage of girls who report experiencing physical violence in
the past 12 months
8 Percentage of girls who report intervening to reduce emotional
violence against their peers in the past 12 months
9 Percentage of girls who report intervening to reduce physical
violence against their peers in the past 12 months
10
Percentage of girls who report being absent from school in the
past 2 weeks
11
Percentage of girls accessing at least one school-related
entitlement (cash, bicycles, books, midday meal scheme)
12
Percentage of girls who drank alcohol in the past month
Tertiary outcomes
1 Percentage of girls who took at least four iron and folic acid
supplements in the past month
2 Percentage of girls aged 15–19 and all married girls who have
correct knowledge about the contraceptive pill, condoms and the
IUD
3 Percentage of girls who use sanitary napkins or clean cloths during
their period
4 Percentage of girls aged 15–19 and all married girls who know
that abortion is legal
5 Percentage of girls who have received take home rations in the
past month
6 Percentage of girls underweight (less than −2 SD median BMI for
age and sex)
7 Percentage of girls stunted (less than −2 SD median height for age
and sex)
8 Mean MUAC score
BMI body mass index, IUD intra-uterine device, MUAC Mid Upper
Arm Circumference
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Content courtesy of Springer Nature, terms of use apply. Rights reserved.
observing success in conjunction with one, two or three
significant benefits observed for individual outcomes is
3.38% (3 × 0.025 × 0.95
2
× 0.5), 0.18% (3 × 0.025
2
× 0.95)
and 0.00% (0.025
3
), respectively. Consequently, the over-
all probability is 3.56%, and the type I error rate assum-
ing a symmetric definition of overall trial failure (harm)
is 7.12%. For primary and secondary outcomes, we will
conduct cross-sectional analyses to compare differences
between the control and intervention arms of the trial,
using regression models with generalised estimating
equations (GEEs) to adjust for clustering and model
baseline and endline information together. We will use
the exchangeable working correlation structure. To as-
sess the effect of the intervention, our regression models
will include an indicator of time (endline vs. baseline)
and an indicator of intervention, coded 1 for participants
measured at endline in the intervention arm and 0
otherwise. This analysis approach has been termed a
‘constrained baseline analysis’[30]. Our baseline data
show that dietary diversity is slightly positively skewed
and BPM-Y scores are very positively skewed. We will
model mean dietary diversity scores using linear regres-
sion. We will model BPM-Y scores using linear regres-
sion after transformation by the function log(1 + x),
noting that our analytic approach (marginal model fitted
by GEE) provides robustness by avoiding distributional
assumptions. We will use a logistic regression model to
test for a difference in the percentage of girls attending
school between arms as a binary outcome. We will ad-
just for the same set of pre-specified prognostic factors
(asset quintile, tribal status and age) and for strata for
each outcome. We will additionally adjust for further
socio-economic factors, should the data monitoring
committee note important imbalances between arms
among baseline participants. However, because there
could be collinearity between such factors or between
such factors and the pre-specified prognostic factors,
it may be that not all can be included or that some
may need to combined. The final model will be se-
lected without reference to intervention effect (i.e.,
without seeing the impact of different potential
models on the intervention effect estimate). We do
not plan to conduct any sensitivity analysis for the ef-
fects of missing data, because the refusal rate for the
endline survey is expected to be low (< 1%), in line
with the baseline survey. We think that short-term
cross-over between intervention and control areas is
likely to be rare, because the main reason for moving
is to attend boarding school, and there are few board-
ingschoolsinourstudyclusters.Wewillbeableto
identify participants who have crossed over through
their exposure to the intervention and will provide an
estimate of ‘contamination’, though we expect this to
be less than 1% of participants.
We plan to carry out two sub-group analyses for the
primary outcomes. The first will assess the effects of the
intervention on the primary outcomes by age, categoris-
ing girls as younger (10–14 years) or older (15–19 years).
The second will examine intervention effects on the
primary outcomes by household wealth quintile. For
sub-groups of age and wealth quintile, the intervention
effects will be presented within each sub-group following
the same approach as in the main analyses. Formal
testing for a difference in intervention effect across sub-
groups will be based on testing interaction terms.
Tertiary outcomes that are present in the theory of
change will be reported in the process evaluation as
exploratory analyses.
We will convene a data monitoring committee in 2019
and 2020 to (1) examine the comparability of trial arms
and potentially identify socio-economic variables that
differ between arms to adjust for in the final analysis, (2)
approve our data analysis plan and ensure we conduct
the final analyses in accordance with this, and (3) pro-
vide recommendations on the interpretation of results
and additional analyses.
The anonymised trial dataset with data on primary
and secondary outcomes and code used in the main ana-
lyses will be made available as supplementary files with
the main trial publication.
Process evaluation
Through a process evaluation, we will assess intervention
implementation (participation in the intervention and
whether the intervention was delivered as intended),
mechanisms of impact, and context (effect of context on
implementation and outcomes) [31]. Process evaluation
data will be collected using (1) semi-structured interviews
and focus group discussions with adolescents and mem-
bers of the community youth team in purposively selected
clusters, (2) observation of intervention activities and in-
teractions with adolescents and other community mem-
bers, (3) forms to document attendance at intervention
activities and to capture problems and strategies identified
by the participatory adolescent groups, and (4) data collec-
tion through the endline survey to measure participation
of adolescents in intervention activities. Some of the infor-
mation will be collected quarterly/monthly, whereas other
information will be collected towards the end of the inter-
vention. Information that will be collected on an ongoing
basis includes socio-demographic profiles of participants
attending intervention activities, prioritised problems and
strategies, progress on implementing strategies, spontan-
eously reported adverse events, training feedback based on
the meeting contents, and feedback from participants
during meetings. Group discussions and semi-structured
interviews with adolescents, parents and frontline workers
will be conducted at the end of the intervention. We do
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Content courtesy of Springer Nature, terms of use apply. Rights reserved.
not have financial resources to conduct a full eco-
nomic evaluation but will report intervention costs
from a provider perspective to guide future decisions
on implementation.
Ethical considerations
In May 2016, we obtained ethical approval for the study
from an independent ethics committee in Jharkhand
convened by Ekjut and from the University College
London Ethics Committee. The study presents several
ethical considerations.
Need for cluster-level consent from village leaders and
individual-level consent from girls and their parents/caregivers
Ekjut have previously worked in the study area and are
familiar with the village leaders and communities. We
sought consent for each village’s participation from the
local village governance institutions (Panchayat and
headmen) and opinion leaders after explaining the
study’s purpose and processes. Adolescent girls aged 18
or above were asked to provide informed consent for
themselves in the baseline survey, and this will be re-
peated at endline. For girls aged 10–17, we will first
seek informed consent from their parents/caregivers.
We will not collect data from any girls if they have
not themselves provided assent, regardless of whether
their caregivers have.
Ensuring confidentiality
As during the baseline, monitors will conduct interviews
for the endline survey in or around girls’homes in a
place of the girl’s choosing, ideally out of earshot but
within sight of family and neighbours. This will protect
confidentiality and ensure that the girl feels comfortable
and safe during the interview. Data will be collected on
mobile phones, stored on password-protected computers
and backed up every 2 weeks. Names of participants will
be removed from the final datasets.
Identification of severely anaemic, severely acutely
malnourished, or mentally distressed girls and girls exposed
to severe violence
As in the baseline survey, all girls showing symptoms of
severe anaemia and those who are severely acutely mal-
nourished, in both intervention and control arms in the
endline, will be referred to the nearest health facility.
Girls with severe mental health problems or who report
experiencing sexual or severe physical violence will be
visited by a trained counsellor from Ekjut who will
review their case and refer as appropriate to a local
health facility or other relevant service (e.g., adolescent-
friendly clinics under RKSK). All girls participating in
the study will be provided with the contact details of a
person in Ekjut.
Benefits to control areas
If the intervention is successful, we will apply for fund-
ing to scale it up in the control arm. During the trial,
livelihood promoters will work in both intervention and
control clusters to offer a range of activities related to
farming practices and environmental management. This
was chosen to offer a minimum common benefit to all
trial areas to help build support for the research across
trial arms.
Increased demand on local health services
Through the intervention, adolescents will be encour-
aged to seek help from community health services for
various health care needs, including family planning,
symptoms of anaemia and mental health problems. We
will link the community youth team to the health
workers by inviting them to attend participatory adoles-
cent group meetings and supporting referrals of adoles-
cents to community health facilities.
Intervention generalisability, sustainability and scalability
We expect our results will be generalisable to other
areas of rural India with a high proportion of Scheduled
Tribes, such as Odisha, Chhattisgarh, Madhya Pradesh
and Rajasthan.
The Government of India has committed to providing
peer education through community groups across India
through the RKSK programme. Our intervention model
is potentially scalable through this programme. Through
the study, we will explore how training and supervision
of peer facilitators could be sustained by frontline health
workers such as Sahiyas (accredited social health activ-
ist), Sevikas (Anganwadi worker) and auxiliary nurse
midwives. We will also explore the feasibility of involv-
ing existing education and health personnel, such as
teachers and health workers, in the delivery of the youth
leadership and livelihood promotion activities.
Dissemination
At the beginning of this study, we convened an expert
group of representatives from the state government and
from local and international non-governmental organisa-
tions working on adolescent health and development to
participate in the design of the intervention. This helped
to ensure the intervention is compatible with existing
health and education systems, builds on the experience
of local stakeholders, and is potentially scalable. We will
re-engage this expert group at the end of the trial in
order to disseminate results among those involved in ado-
lescent health policy and programming. To disseminate
our findings in the study area, we will hold community-
level meetings, drawing on previously tested dissemination
techniques (e.g., ‘traffic light signs’to show which adoles-
cent health outcomes have improved during the trial and
Rath et al. Trials (2020) 21:52 Page 11 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
which have not). We will also share results with the
adolescents who participated in our intervention dur-
ing the trial.
Discussion
We have developed a holistic, participatory intervention
to mobilise rural communities to take action for adoles-
cent health and development, and we are evaluating it
through a cluster-randomised controlled trial. To the
best of our knowledge, this is the first trial in India of an
integrated community intervention to improve adoles-
cent health and development in tribal communities.
Through the process evaluation, we aim to understand
to what extent girls from these communities and
other marginalised groups are able to participate in
the intervention and how it achieves any effects de-
tected. We will also try to understand factors that
could facilitate or inhibit scale-up of the intervention
in other tribal areas of India.
Several trials in India have evaluated community inter-
ventions for adolescents, mainly in school settings. A
school-based intervention for girls aged 11–14 in Uttar
Pradesh involving peer and parental support and ses-
sions on compassion, well-being and self-efficacy im-
proved nutrition, hygiene and reproductive health
behaviours [32]. A psychosocial resilience curriculum for
girls (mean age, 12 years) in Bihar improved gender-
equitable attitudes; health knowledge and behaviours;
and resilience, self-efficacy, social-emotional assets and
well-being [7,33]. In Goa, a pilot trial evaluated a multi-
component intervention for boys and girls aged 16–24
in rural and urban communities [18]. The intervention
reduced self-reported violence perpetration and probable
depression, and it improved knowledge and attitudes
about reproductive and sexual health in both rural and
urban settings. A trial of a multi-level, structural and
norms-based intervention in Karnataka found no evi-
dence of a reduction in school drop-out and child mar-
riage among girls aged 12–13 [34]. The whole-school
SEHER (Strengthening Evidence base on scHool-based in-
tErventions for pRomoting adolescent health programme)
intervention delivered by lay counsellors in Bihar im-
proved school climate and health-related outcomes among
secondary school students (including depression, bullying
and violence victimisation) [35].
Our study has several strengths. The intervention tar-
gets adolescents across the whole span of adolescence
(10–19 years) and includes in- and out-of-school and
married and unmarried adolescents. Involving boys and
girls in the intervention activities will enable us to tackle
issues related to gender norms and hopefully to provide
benefits for both genders. The intervention builds on the
government’s existing national adolescent health com-
munity strategy (RKSK). It has also been informed by an
extensive mixed-methods formative study. The study
also has limitations. Our primary outcomes are self-
reported. Girls in intervention areas may be more likely
to over-report mental health problems, minimum dietary
diversity and school attendance due to awareness-raising
intervention activities on these issues. We seek to ad-
dress this in several ways. First, the data collection team
is separate from the intervention team, reducing the ex-
tent to which participants relate the two, thus reducing
potential social desirability bias. Second, interviewers are
experienced and rigorously trained in rapport-building.
This will help participants feel comfortable and able to
answer questions truthfully. Third, for the school attend-
ance outcome, we will cross-check a random sample of
answers against school registers. Fourth, there may be
migration of adolescents into and out of the study clus-
ters. We will ask about length of residence in the cluster
at endline to check for any systematic bias in in-
migration between the intervention and control arms,
though this is unlikely. Finally, because intervention ac-
tivities are open to any adolescent, we cannot rule out
the possibility that adolescents in control areas will par-
ticipate. However, clusters were purposively selected so
that natural boundaries (e.g., roads, rivers, forestry) be-
tween clusters reduce the likelihood of this.
Our findings will help to inform the implementation
of RKSK and will contribute to the evidence base for
community interventions to improve adolescent health
and development in other settings.
Trial status
The trial is ongoing. The endline survey will take place
between February and April 2020.
Supplementary information
Supplementary information accompanies this paper at https://doi.org/10.
1186/s13063-019-3984-1.
Additional file 1. Intervention theory of change.
Additional file 2. Short video clip with the research team describing
the intervention.
Additional file 3. Trial outcomes and detailed questionnaire items.
Additional file 4. SPIRIT 2013 checklist.
Abbreviations
BMI: Body mass index; BPM-Y: Brief Problem Monitor–Youth; GEE: Generalised
estimating equation; ICC: Intra-cluster correlation coefficient; IUD: Intra-
uterine device; JIAH: Jharkhand Initiative for Adolescent Health; LMICs: Low-
and middle-income countries; PLA: Participatory Learning and Action;
RKSK: Rashtriya Kishor Swasthya Karyakram
Acknowledgements
We thank members of the local advisory committee supporting the
community youth teams, including the Child Protection Officer and
Probation Officer from the District Child Protection Unit, all members and
the chairperson from the Child Welfare Committee, the Office Legal Assistant
from the District Legal Services Authority, and non-governmental
Rath et al. Trials (2020) 21:52 Page 12 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
organisation representatives. We also thank the young people, parents and
teachers who took part in the formative research and intervention.
Sponsor
University College London is the trial’s sponsor. The contact person at UCL is
audrey.prost@ucl.ac.uk. The sponsor has no role in the study design;
collection, management, analysis and interpretation of data; writing of the
report; or the decision to submit the report for publication. HP and AP will
have access to the final dataset.
Protocol version and date
1.4, 1st November 2019.
Authors’contributions
NN, SR, ShR, PT, KRC and AP conceptualized the study. AP obtained funding.
NN, SuR, SG and SS led the development of the JIAH intervention with
support from the other authors. KRC, SuR, SS, AC and AP drafted the article.
HP and ShR led the data collection team. HP is the data manager. All
authors read, commented on and approved the manuscript.
Funding
The study is supported by a programme grant from the Children’s
Investment Fund Foundation to Ekjut and University College London.
Availability of data and materials
The Standard Protocol Items: Recommendations for Interventional Trials
(SPIRIT) checklist has been completed and made available (Additional file 4).
Ethics approval and consent to participate
Ethical approval for the trial was obtained from an independent ethics
committee in Jharkhand convened by Ekjut on 7 May 2016 and University
College London Ethics Committee (reference 2656/002) on 24 May 2016.
Informed consent is obtained from all participants.
Competing interests
The authors declare that they have no competing interests.
Author details
1
Ekjut, Chakradharpur, Jharkhand, India.
2
Institute for Global Health, University
College London, London, UK.
3
Department of Global Health and Social
Medicine, King’s College London, Bush House NE Wing, London WC2B 4BG,
UK.
Received: 3 December 2018 Accepted: 10 December 2019
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