Condition category
Not Applicable
Date applied
15/01/2018
Date assigned
06/02/2018
Last edited
05/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://ciff.org/

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

foundation

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

foundation

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

Publication citations

Additional files

Editorial Notes