Plain English Summary
Background and study aims
Adolescence is increasingly recognised as a crucial life stage from both a social and developmental perspective. Decisions made during adolescence – from dropping out from school, to getting married early, to engaging in risky behaviours – can have lifelong implications. At the same time, this is an important period of neurobiological (mental) development, particularly of socio-emotional and non-cognitive skills. In all, these two factors make adolescence a period of heightened vulnerability to adverse environmental factors but also an opportunity for intervention. Adolescent girls in rural India face particular pressures: poverty, highly conservative gender norms and customs around women’s marriage, education and role within the household combine to put girls at exceptionally high risk of child marriage, poor sexual and reproductive health, early drop-out from school, poor mental health and poor development of key socio-emotional and non-cognitive skills. The aim of this study is to assess the impact of an integrated community-based programme, PAnKH, on adolescent girls’ marriage, education, mental health, gender attitudes and socio-emotional and non-cognitive skills. Through providing information and skills, the programme aims to help girls stay in or return to school, resist child and early marriage practices and make informed decisions about their sexual and reproductive health needs. Through providing a safe and supportive space and specific training around negotiation skills it hopes to improve girls’ mental health and non-cognitive skills. Moreover, PAnKH aims to positively transform norms and values relating to girls in their communities.
Who can participate?
Adolescent girls aged between 12-17 (unmarried) or 12-19 (married), their parents and in-laws and other community members
What does the study involve?
Participating villages are randomly allocated to one of three groups. In the first group adolescent girls are directly engaged through group education and weekly sports sessions. In the second group the wider community are also engaged with and mobilised by community campaigns and events targeting similar issues with the wider community. The third group does not receive any intervention. The study assesses how feasible it is for community-based programmes to alter key outcomes for adolescent girls.
What are the possible benefits and risks of participating?
Possible benefits of participating in the study include access (in allocated villages) to the PANKH program which aims to increase girls' understanding of gender, early marriage, education and sexual and reproductive health as well as build up soft skills and mental health. Possible risks include girls facing adverse community or family reaction due to participating in the program due to its novelty in this context. To mitigate this risk program staff have reached out to community leaders and members at large to discuss the aims of the program and take on board any concerns.
Where is the study run from?
International Centre for Research on Women (India)
When is the study starting and how long is it expected to run for?
March 2015 to May 2018
Who is funding the study?
1. Children's Investment Fund Foundation
2. John D. and Catherine T. MacArthur Foundation
3. Pentland
Who is the main contact?
1. Alison Andrew
alison_a@ifs.org.uk
2. Dr Sonya Krutikova
sonya_k@ifs.org.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Alison Andrew
ORCID ID
http://orcid.org/0000-0002-8908-9683
Contact details
Institute for Fiscal Studies
7 Ridgmount Street
London
WC1E 7AE
United Kingdom
+44 (0)20 7291 4800
alison_a@ifs.org.uk
Type
Scientific
Additional contact
Dr Sonya Krutikova
ORCID ID
Contact details
Institute for Fiscal Studies
7 Ridgmount Street
London
WC1E 7AE
United Kingdom
+44 (0)20 7291 4800
sonya_k@ifs.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Promoting adolescent engagement, knowledge and health evaluation of PAnKH: an adolescent girl intervention in Rajasthan, India
Acronym
Study hypothesis
1. Community-based programmes in rural Rajasthan targeting adolescent girls can have a positive effect on early marriage, education, mental health, socio-emotional and non-cognitive skills and gender attitudes.
2. Integrated programmes that engage with adult members of the community can have a positive effect when compared to intervening with adolescent girls alone.
Ethics approval
1. International Center for Research on Women - Institutional Review Board, 03/08/2015, ref: 15-0001
2. Sigma-IRB, India, 27/07/2015, ref: 10005/IRB/D/15-16
3. Social Sciences & Humanities Inter-Divisional Research Ethics Committee, University Of Oxford, 15/12/2015, ref: R43389
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Adolescent engagement, knowledge and health
Intervention
This is a cluster randomised controlled trial with 90 clusters (villages or groups of nearby villages) designed to evaluate the effectiveness of two models of PAnKH, a community-based programme targetting the outcomes of adolescent girls in rural Rajasthan, India. As such, 30 clusters were allocated using random numbers generated on STATA to:
1. Control group: The control group does not receive any intervention
2. Girls' only intervention: 40-45 Group Education Activities (GEAs) for adolescent girls as well as weekly sports sessions. The GEAs follow a curriculum designed to address topics related to gender norms, gender-based violence, sexual and reproductive health and education as well as promoting girls socio-emotional and non-cognitive skills and wellbeing
3. Integrated intervention. GEAs were complemented by community campaigns and events targeting similar issues with the wider community
Interventions last for 18 months in total and follow-up data is collected for approximately 24 months after baseline.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Early marriage:
1.1. Proportion of girls ever married (BL, EL)
1.2. Proportion of girls married before each age 13-19 (BL, EL)
2. Education:
2.1. Proportion of girls currently in school (BL, EL)
2.2. Proportion of girls who dropped out of school before each age 13-19 (BL, EL)
3. Mental health:
3.1. Depression, measured using PHQ-9 (EL)
3.2. Anxiety, measured using GAD-7 (EL)
3.3. Rumination, measured using RSS-10 (EL)
4. Socio-emotional and non-cognitive skills:
4.1. Self-efficacy, measured using GSE-10 (BL, EL)
4.2. Self-esteem, measured using SDQ-GS (BL, EL)
4.3. Peer relations, measured using SDQ-PR (BL, EL)
4.4. Resilience, measured using CD-RISC-10 (EL)
4.5. Decision making – vigilance, measured using DMQ (EL)
4.6. Decision making – buck passing, measured using DMQ (EL)
5. Gender attitudes:
5.1. Gender attitudes of girls, measured using adapted GEMS scale (BL, EL)
5.2. Gender attitudes of caregivers, measured using adapted GEMS scales (BL, EL)
(BL=measured at baseline, EL=measured at endline, roughly 24 months after BL)
Secondary outcome measures
1. Attitude towards school:
1.1. School attitudes scale – scale devised by authors, details in pre-analysis plan (EL)
2. Knowledge of sexual and reproductive health:
2.1. Puberty and menstruation knowledge scale – scale devised by authors (EL)
2.2. Contraception and sexual health knowledge scale – scale devised by authors (EL)
3. Attitudes and responses to violence:
3.1. Girls’ ‘victim blaming’ tendencies for violence against women and girls – scale devised by authors (EL)
3.2. Girls’ ‘perpetrator blaming’ tendencies for violence against women and girls– scale devised by authors (EL)
3.3. Girls’ ‘avoidance behaviours’ in response to violence against women and girls– scale devised by authors (EL)
3.4. Girls’ ‘retaliation behaviours’ in response to violence against women and girls– scale devised by authors (EL)
3.5. Girls’ ‘reporting behaviours’ in response to violence against women and girls– scale devised by authors (EL)
3.6. Carers’ ‘victim blaming’ tendencies for violence against women and girls– scale devised by authors (EL)
3.7. Carers’ ‘perpetrator blaming’ tendencies for violence against women and girls– scale devised by authors (EL)
3.8. Carers’ ‘avoidance behaviours’ in response to violence against women and girls– scale devised by authors (EL)
3.9. Carers’ ‘retaliation behaviours’ in response to violence against women and girls– scale devised by authors (EL)
3.10. Carers’ ‘reporting behaviours’ in response to violence against women and girls– scale devised by authors (EL)
4. Sports:
4.1. Attitude to and enjoyment of sports – sports attitudes scale – scale devised by authors (EL)
4.2. Participation in sports – time spent playing sport in a typical week (minutes) (EL)
5. Restrictions during menstruation:
5.1. Restrictions during menstruation scale– scale devised by authors (BL, EL)
(BL=measured at baseline, EL=measured at endline, roughly 24 months after BL)
Overall trial start date
01/03/2015
Overall trial end date
31/05/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adolescent girls aged between 12-17 (unmarried) or 12-19 (married) at baseline living in the 90 study clusters
Participant type
Other
Age group
Mixed
Gender
Female
Target number of participants
7574 girls at baseline
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/11/2015
Recruitment end date
15/01/2016
Locations
Countries of recruitment
India
Trial participating centre
International Centre for Research on Women
C – 59, South Ext, Part II, New Delhi
Delhi
110049
India
Sponsor information
Organisation
Children’s Investment Fund Foundation
Sponsor details
7 Clifford Street
London
W1S 2FT
United Kingdom
Sponsor type
Charity
Website
Organisation
MacArthur Foundation
Sponsor details
India Habitat Centre
Zone VA
First Floor
Lodhi Road
Delhi
110 003
India
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Children's Investment Fund Foundation
Alternative name(s)
CIFF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Funder name
John D. and Catherine T. MacArthur Foundation
Alternative name(s)
MacArthur Foundation, John D. & Catherine T. MacArthur Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United States of America
Funder name
Pentland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists plan to publish results in a mixture of high-impact peer review medical/public health journals and economics journals. They aim to submit for publication within one year of the trial end date.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/05/2019
Participant level data
Other
Basic results (scientific)
Publication list
2018 statistical analysis plan in: https://www.ifs.org.uk/publications/10347