Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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20 June 2023 |
Main ID: |
ISRCTN77449378 |
Date of registration:
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06/02/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Promoting adolescent engagement, knowledge and health evaluation of PAnKH: an adolescent girl intervention in Rajasthan, India
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Scientific title:
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Promoting adolescent engagement, knowledge and health evaluation of PAnKH: an adolescent girl intervention in Rajasthan, India |
Date of first enrolment:
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01/11/2015 |
Target sample size:
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7574 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN77449378 |
Study type:
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Interventional |
Study design:
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Cluster randomised controlled trial (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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India
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Alison
Andrew |
Address:
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Institute for Fiscal Studies
7 Ridgmount Street
WC1E 7AE
London
United Kingdom |
Telephone:
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+44 (0)20 7291 4800 |
Email:
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alison_a@ifs.org.uk |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Adolescent girls aged between 12-17 (unmarried) or 12-19 (married) at baseline living in the 90 study clusters
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Adolescent engagement, knowledge and health Not Applicable
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Intervention(s)
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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.
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Primary Outcome(s)
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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)
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Secondary Outcome(s)
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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)
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Secondary ID(s)
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AEARCTR-0002656
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Source(s) of Monetary Support
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Children's Investment Fund Foundation, John D. and Catherine T. MacArthur Foundation, Pentland
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Ethics review
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Status:
Approval date:
Contact:
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
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/05/2018 |
URL:
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