Condition category
Not Applicable
Date applied
25/06/2018
Date assigned
27/06/2018
Last edited
27/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background to the study
India is home to around 20% of the world’s adolescent girls. Adolescents living in rural, underserved areas face multiple challenges to their wellbeing, with long-term consequences for their health, educational and socio-economic opportunities. The aim of this study is to test whether an intervention involving Community Youth Teams facilitating participatory peer-led adolescent groups, youth leadership training, and livelihood promotion can improve school attendance, dietary diversity and mental health among adolescent girls in rural India.

Who can participate?
Adolescent girls and boys aged 10-19 living in villages and adjoining hamlets located in rural areas of Jharkhand (eastern India)

What does the study involve?
Participating areas are randomly allocated to receive the community intervention or to a control group. Each intervention area has a Community Youth Team composed of three people: a peer facilitator aged 20-25 called a ‘yuva saathi’, meaning friend of youth chosen from the community, a youth leadership facilitator, and and a livelihood promoter. Yuva saathis facilitate monthly participatory groups for adolescent girls and boys. In the first five meetings, they introduce the intervention, discuss social and economic factors that affect adolescents’ health, how to involve vulnerable adolescents in the groups, gender norms and their consequences, and the adolescents’ needs and expectations. These initial meetings are open to all community members, teachers and frontline health workers. After they have been completed, the groups work through four consecutive Participatory Learning and Action (PLA) cycles that cover four themes: education, nutrition, health and violence. Each PLA cycle comprises five to seven meetings and has four phases: (i) identifying problems affecting adolescents in the community (meeting 1); (ii) identifying and deciding on strategies to address these problems (meetings 2-3); (iii) implementing the strategies (meetings 4-6); and (iv) evaluating the process (meeting 7). The second member of the Community Youth Team who is a youth leadership facilitator delivers confidence-building activities for adolescents every two months. Activities are open to all girls and boys in the community, and include sports events such as football tournaments, archery, run-a-thon, and problem management sessions and nature walks. Finally, both intervention and control areas have livelihood promoters, who are adults recruited for their skills in farming and environmental management. Livelihood promotion activities aim to provide adolescents with practical skills that they can use in later life, improve food security for families, and provide a common benefit to both intervention and control groups. Livelihood promotion activities run every three months, reflect the seasons, are selected in consultation with communities and are family-focused, involving both adolescents and their parents. They include paddy cultivation, multi-cropping, compost-making techniques, tree planting, rain water harvesting and the revival of farmer’s committees and forest groups.

What are the possible benefits and risks of participating?
There are three main benefits of taking part. Both intervention and control areas receive a livelihood promotion intervention to strengthen adolescents’ practical livelihood-related skills and families’ food security. In both intervention and control areas, girls with severe health problems will benefit from referrals to relevant services. Girls who have symptoms of severe anaemia or are severely acutely malnourished will be referred to the nearest district hospital. Girls with severe mental health problems, or who report experiencing sexual or severe physical violence, will be visited by a trained counselor from Ekjut who will review their case and refer as appropriate to a local health facility or other relevant service. Finally, if the intervention is found to improve adolescents’ dietary diversity, school attendance or mental health, there may be further benefit to control clusters and similar areas if the study influences further support for Community Youth Teams in rural India. There are no known risks of participating for adolescents.

Where is the study run from?
In India, the study is led by the civil society organization Ekjut. In the UK, the study is supported by University College London’s Institute for Global Health and the London School of Hygiene and Tropical Medicine

When is the study starting and how long is it expected to run for?
December 2015 to August 2020

Who is funding the study?
Children’s Investment Fund Foundation (UK)

Who are the main contact persons?
1. Suchitra Rath
2. Audrey Prost

Trial website

Contact information

Type

Scientific

Primary contact

Prof Audrey Prost

ORCID ID

Contact details

London School of Hygiene and Tropical Medicine
Department of Global Health and Development
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom

Type

Scientific

Additional contact

Ms Suchitra Rath

ORCID ID

Contact details

Ekjut
Ward No 17 – 556 B - Potka
Chakradharpur
West Singhbhum
Jharkhand
833102
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Community Youth Teams facilitating participatory adolescent groups, youth leadership training and livelihood promotion activities to improve school attendance, dietary diversity and mental health among adolescent girls aged 10-19 years in rural eastern India: a cluster-randomised controlled trial

Acronym

JIAH (Jharkhand Initiative for Adolescent Health)

Study hypothesis

Community Youth Teams: (i) facilitating participatory adolescent groups; (ii) youth leadership training; and (iii) livelihood promotion meetings, will improve school attendance, dietary diversity and mental health among girls aged 10-19 years in rural Jharkhand (eastern India).

Ethics approval

1. University College London Research Ethics Committee, 24/05/2016, ref: 2656/002
2. Ekjut Independent Ethics Committee, 07/05/2016

Study design

Cluster randomised controlled trial, parallel design

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Adolescent health

Intervention

The study has recruited 38 geographical clusters of around 1000 population each, composed of villages and adjoining hamlets located in rural areas of Jharkhand (eastern India). Trial participants are all adolescent girls aged 10-19 years who agree to be interviewed and are living in the 38 study clusters during the baseline and/or endline surveys. Intervention participants are adolescent boys and girls aged 10-19 years within the study area. For financial and logistical reasons, the trial outcomes relate only to girls. However, the trialists decided to include both adolescent boys and girls in the intervention because it could be beneficial to boys, and some problems may be more effectively addressed by engaging with both boys and girls. Participation in intervention activities is voluntary.

Randomisation was conducted in February 2017. 19 clusters were allocated to the intervention arm and 19 to the control arm. Randomisation was stratified according to whether clusters had (i) a secondary school, (ii) an adolescent club and (iii) a population size of 1500 or above. To ensure transparency of the randomisation process, the trialists invited people from the local community to participate. They explained the intervention and the purpose of randomisation to the participants. Clusters were numbered and displayed on the wall. Participants placed a set of identical balls numbered from 1 to 38, corresponding to each of the 38 clusters, in a tombola machine. They operated the machine and sequentially allocated each ball to the intervention and control arms.

Each intervention cluster has a Community Youth Team composed of three people: (1) a peer facilitator aged 20-25 called a ‘yuva saathi’, meaning friend of youth (one girl per cluster and one boy for two clusters) chosen from the community; (2) a youth leadership facilitator (one for 6-7 clusters); (3) and a livelihood promoter (one for 9-10 clusters).

Yuva saathis facilitate monthly participatory groups for adolescent girls and boys. In the first five meetings, they introduce the intervention, discuss social and economic factors that affect adolescents’ health, how to involve vulnerable adolescents in the groups, gender norms and their consequences, and the adolescents’ needs and expectations. These initial meetings are open to all community members, teachers and frontline health workers. After they have been completed, the groups work through four consecutive Participatory Learning and Action (PLA) cycles that cover four themes: education, nutrition, health and violence. Each PLA cycle comprises five to seven meetings and has four phases: (i) identifying problems affecting adolescents in the community (meeting 1); (ii) identifying and deciding on strategies to address these problems (meetings 2-3); (iii) implementing the strategies (meetings 4-6); and (iv) evaluating the process (meeting 7). These themes were selected on the basis of formative research and reflect the broad dimensions of adolescent health and development, as well as the content of the national curriculum for adolescent health (Rashtriya Kishore Swasthya Karyakram, or RKSK).

The trialists' formative research also identified the need for participatory groups to be complemented by engaging in, fun and confidence-building activities. The second member of the Community Youth Team who is a youth leadership facilitator delivers confidence-building activities for adolescents every two months. Activities are open to all girls and boys in the community, and include sports events such as football tournaments, archery, run-a-thon, and problem management sessions and nature walks.

Finally, 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 adolescents with practical skills that they can use in later life, improve food security for families, and provide a common benefit to both intervention and control arms. Livelihood promotion activities run every three months, reflect the seasons, are selected in consultation with communities and are family-focused, involving both adolescents and their parents. They include paddy cultivation, multi-cropping, compost-making techniques, tree planting, rain water harvesting and the revival of farmer’s committees and forest groups.

The total duration of the intervention is 36 months. There is no follow-up period after the intervention ends.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Assessed during the endline survey:
1. Mean dietary diversity score among adolescent girls
2. Mean score on the Brief Problem Monitor – Youth
3. % of adolescent girls attending school

Secondary outcome measures

Assessed during the endline survey:
1. % 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. % of girls making decisions independently and with others about friends, spending money and purchases
4. Mean score on the Schwarzer General Self-Efficacy Scale
5. Mean score on the Child and Youth Resilience Measure 11-item version (CYRM-Brief)
6. % of girls who report experiencing emotional violence in the past 12 months
7. % of girls who report experiencing physical violence in the past 12 months
8. % of girls who report intervening to reduce emotional violence against their peers in the past 12 months
9. % of girls who report intervening to reduce physical violence against their peers in the past 12 months
10. % of girls who report being absent from school in the past two weeks
11. % of girls accessing at least one school-related entitlement (cash, bicycles, books, midday meal scheme)
12. % of girls who drank alcohol in the past month

Overall trial start date

01/12/2015

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Eligibility for the baseline and endline survey:
Adolescent girls aged 10-19 years who are living in the study area and agree to be interviewed are eligible to participate in the baseline and endline surveys. Married and unmarried girls will be included in the surveys, as well as in school and out of school girls, and girls living in the same household. Girls will be excluded if they are unavailable for interview at the time of the survey because they have either migrated permanently or migrated temporarily and are not available following at least three repeat visits.

Eligibility to receive the intervention:
Intervention activities are open to all adolescent girls and boys aged 10-19 years living in the study area. This includes adolescents who are married or unmarried and who are in-school or out-of-school. It also includes adolescents who move into or out of the study area during the study. Adolescents themselves determine the extent to which they engage in the intervention activities and therefore exposure will vary at an individual level.

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

Between 6000-7000 adolescent girls aged 10-19 years (3324 in baseline – already completed, and between 3000-4000 estimated at endline)

Participant exclusion criteria

For baseline and endline surveys:
Girls who are unavailable for interview at the time of the survey because they have migrated permanently or migrated temporarily and are not available following repeat visits.

For the intervention:
No adolescent or other community members are excluded from intervention activities.

Recruitment start date

01/03/2016

Recruitment end date

30/06/2020

Locations

Countries of recruitment

India

Trial participating centre

Ekjut
Ward No 17 – 556 B - Potka Chakradharpur, West Singhbhum
Jharkhand
833102
India

Sponsor information

Organisation

Ekjut

Sponsor details

Ward No 17 – 556 B - Potka
Chakradharpur
West Singhbhum
Jharkhand
833102
India

Sponsor type

Other

Website

http://www.ekjutindia.org/

Organisation

London School of Hygiene and Tropical Medicine

Sponsor details

Department of Global Health and Development
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom

Sponsor type

University/education

Website

https://www.lshtm.ac.uk/

Funders

Funder type

Charity

Funder name

Children's Investment Fund Foundation

Alternative name(s)

CIFF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study protocol and statistical analysis plan will be published and available online. The trialists plan to publish the trial results in a high-impact peer-reviewed journal in August 2021.

IPD sharing statement
The anonymised dataset analysed during the current study will be made available as a .csv file with the main results publication, along with a text file containing Stata code to reproduce the analyses.

Intention to publish date

01/08/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes