Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03610568 |
| Other study ID # |
7510 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2017 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Johns Hopkins Bloomberg School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Global Early Adolescent Study (GEAS) is the first international study exploring how
gender norms evolve over time and inform a spectrum of adolescent health outcomes, including
sexual and mental health, through the adolescent years. Institutional Review Board (IRB)
oversight for all instrument development was provided for the first phase of the GEAS under
IRB #00005684. The present study is in reference to the second, longitudinal phase of the
GEAS. This phase, like the first, will be conducted in multiple international sites. However,
because the longitudinal phase will likely be paired with different interventions or
approaches in the partner sites, protocol details will vary and thus IRB approval will be
sought for each site separately. The present application is for conducting Phase 2 of the
Global Early Adolescent Study in Kinshasa, Democratic Republic of the Congo (DRC). In
addition to conducting the study for "pure science" purposes, the GEAS will be used to
evaluate the effectiveness of an intervention implemented by Save the Children.
Description:
The Global Early Adolescent Study (GEAS) is the first international study exploring how
gender norms evolve over time and inform a spectrum of adolescent health outcomes, including
sexual and mental health, through the adolescent years. The first phase, consisting of
formative research and the face validity and pilot testing of instruments among early
adolescents 10-14 years of age across 15 countries, was completed in 2017.
The present study is for Phase 2 of the Global Early Adolescent Study in Kinshasa, Democratic
Republic of the Congo (DRC), and covers both the intervention and control groups. The
longitudinal phase explores how gender norms relate to health across the adolescent years,
beginning with early adolescence (10-14 years old). The GEAS in Kinshasa has two sets of
objectives:
1. To explore how perceptions of gender norms evolve across adolescence, the factors
influencing these changes, and how perceptions of gender norms predict a spectrum of
adolescent outcomes, and
2. Assess the impact of a gender norms transformative intervention developed and
implemented by Save the Children.
The intervention, Growing Up GREAT (GUG), and evaluation components are part of a larger
project, Passages, which is led by the Institute for Reproductive Health (IRH) at Georgetown
University. The investigator's research partner is the Kinshasa School of Public Health
(KSPH), which will implement the GEAS study. Through Passages, Johns Hopkins University (JHU)
receives support primarily from USAID with additional support from the Bill and Melinda Gates
Foundation as a sub-recipient of IRH. Save the Children is separately a sub-recipient of IRH.
This funding supports 3 years of longitudinal research with both control and intervention
groups for impact evaluation in Kinshasa.
In both an intervention and control group 1,400 young people ages 10-14 will be followed over
a period of 3 years, participating in a total of 3 surveys. To gauge effectiveness of the
intervention, the study will assess the following measurable primary and secondary study
outcomes:
