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


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.


BACKGROUND
Clinicaltrials.gov NCT02429661 . Registered 24 April 2015.
CorStone, 250 Camino Alto, Suite 100A, Mill Valley, CA, USA. kates@corstone.org.
Katherine Sachs
KS
Leventhal
QURE Healthcare, 1000 Fourth St., Suite 300, San Rafael, CA, USA. ldemaria@qurehealthcare.com.
Lisa M
LM
DeMaria
Department of Psychology, Swarthmore College, 500 College Avenue, Swarthmore, PA, USA. jgillha1@swarthmore.edu.
Jane
J
Gillham
CorStone India Foundation, c/o Ajay K. Sud & Associates, B-4 Greater Kailash Enclave, Part-II, New Delhi, 110048, India. gracya@corstone.org.
Gracy
G
Andrew
QURE Healthcare, QURE Healthcare, 1000 Fourth St., Suite 300, San Rafael, CA, USA. jpeabody@qurehealthcare.com.
John W
JW
Peabody
CorStone, 250 Camino Alto, Suite 100A, Mill Valley, CA, USA. stevel@corstone.org.
Steve
S
Leventhal
D000293:Adolescent; D000294:Adolescent Behavior; D016497:Adolescent Health Services; D000367:Age Factors; D003479:Curriculum; D004521:Educational Measurement; D004522:Educational Status; D004644:Emotions; D005260:Female; D006304:Health Status; D006801:Humans; D007194:India; D010379:Peer Group; D010809:Physical Fitness; D036301:Qualitative Research; D011788:Quality of Life; D012107:Research Design; D055500:Resilience, Psychological; D019035:Rural Health Services; D012572:School Health Services; D057566:Self Report; D012737:Sex Factors; D012919:Social Behavior