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Published in: Trials 1/2015

Open Access 01-12-2015 | Methodology

Fostering emotional, social, physical and educational wellbeing in rural India: the methods of a multi-arm randomized controlled trial of Girls First

Authors: Katherine Sachs Leventhal, Lisa M. DeMaria, Jane Gillham, Gracy Andrew, John W Peabody, Steve Leventhal

Published in: Trials | Issue 1/2015

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Abstract

Background

There are 600 million girls in low and middle income countries (LMICs), many of whom are at great risk for poor health and education. There is thus great need for programs that can effectively improve wellbeing for these girls. Although many interventions have been developed to address these issues, most focus on health and education without integrating attention to social and emotional factors. This omission is unfortunate, as nascent evidence indicates that these factors are closely related to health and education.
This paper describes the methods of a 4-arm randomized controlled trial among 3,560 adolescent girls in rural Bihar, India that tested whether adding an intervention targeting social-emotional issues (based on a “resilience framework”) to an adolescent health intervention would improve emotional, social, physical, and educational wellbeing to a greater extent than its components and a control group. Study arms were: (1) Girls First, a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC); (2) Girls First Resilience Curriculum (RC) alone; (3) Girls First Health Curriculum (HC) alone; and (4) a school-as-usual control group (SC).

Methods

Seventy-six schools were randomized (19 per condition) and 74 local women with a tenth grade education were trained and monitored to facilitate the program. Quantitative data were collected from 3,560 girls over 4 assessment points with very low rates of participant attrition. Qualitative assessments were conducted with a subset of 99 girls and 27 facilitators.

Results and conclusions

In this article, we discuss guiding principles that facilitated trial implementation, including integrating diverse local and non-local sources of knowledge, focusing on flexibility of planning and implementation, prioritizing systematic measurement selection, and striking a balance between scientific rigor and real-world feasibility.

Trial registration

Clinicaltrials.gov NCT02429661. Registered 24 April 2015.
Appendix
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Footnotes
1
Although the standard age for Stds. VII–VIII in India is approximately 12–14 years, in reality girls are often younger or older than their grade suggests. In this sample, although most girls were within the range of 12–14 years of age, girls in these grades were as young as 9 years and as old as 18 years (Mean = 13.0 years, SD = 1.2 years) at Time 1.
 
2
The minimum was set as 20 girls as this was the minimum number required to form a single intervention group given potential non-response and attendance issues. The maximum of 150 was chosen in order to most closely reflect the rural school environments where Girls First was most likely to be run in the future. Given that the average size of an entire rural school in India is 244 students, [44] a school with more than 150 girls across only 2 grade levels was considered to be well above that average and, therefore, poor proxies for the future rural school environments for Girls First.
 
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Metadata
Title
Fostering emotional, social, physical and educational wellbeing in rural India: the methods of a multi-arm randomized controlled trial of Girls First
Authors
Katherine Sachs Leventhal
Lisa M. DeMaria
Jane Gillham
Gracy Andrew
John W Peabody
Steve Leventhal
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1008-3

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