Promoting adolescent engagement, knowledge and health evaluation of PAnKH: an adolescent girl intervention in Rajasthan, India

ISRCTN	ISRCTN77449378
DOI	https://doi.org/10.1186/ISRCTN77449378
Secondary identifying numbers	AEARCTR-0002656

Submission date: 15/01/2018
Registration date: 06/02/2018
Last edited: 07/06/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Ms Alison Andrew
Scientific

Institute for Fiscal Studies
7 Ridgmount Street
London
WC1E 7AE
United Kingdom

ORCID ID	0000-0002-8908-9683
Phone	+44 (0)20 7291 4800
Email	alison_a@ifs.org.uk

Dr Sonya Krutikova
Scientific

Institute for Fiscal Studies
7 Ridgmount Street
London
WC1E 7AE
United Kingdom

Phone	+44 (0)20 7291 4800
Email	sonya_k@ifs.org.uk

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Promoting adolescent engagement, knowledge and health evaluation of PAnKH: an adolescent girl intervention in Rajasthan, India
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2015
Completion date	31/05/2018

Eligibility

Participant type(s)	Other
Age group	Mixed
Lower age limit	12 Years
Upper age limit	19 Years
Sex	Female
Target number of participants	7574 girls at baseline
Total final enrolment	7577
Key inclusion criteria	Adolescent girls aged between 12-17 (unmarried) or 12-19 (married) at baseline living in the 90 study clusters
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/11/2015
Date of final enrolment	15/01/2016

Locations

Countries of recruitment

India

Study participating centre

International Centre for Research on Women

C – 59, South Ext, Part II, New Delhi
Delhi
110049
India

Sponsor information

Children's Investment Fund Foundation
Charity

7 Clifford Street
London
W1S 2FT
United Kingdom

Website	https://ciff.org/
"ROR"	https://ror.org/00jfgrn87

John D. and Catherine T. MacArthur Foundation
Research organisation

India Habitat Centre
Zone VA, First Floor
Lodhi Road
Delhi
110 003
India

Website	https://www.macfound.org/
"ROR"	https://ror.org/00dxczh48

Funders

Funder type

Charity

Children's Investment Fund Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): CIFF
Location: United Kingdom

John D. and Catherine T. MacArthur Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): MacArthur Foundation, John D. & Catherine T. MacArthur Foundation, JDCTMF
Location: United States of America

Pentland

No information available

Results and Publications

Intention to publish date	31/05/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
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 plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Statistical Analysis Plan	statistical analysis plan	18/01/2018		No	No
Funder report results	Impact evaluation	01/12/2018	13/08/2021	No	No

Editorial Notes

07/06/2023: Internal review.
13/08/2021: The following changes have been made:
1. Funder report added.
2. The final enrolment number has been added from the reference.
3. The AEARCT number has been added to the protocol/serial numbers.