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Global Early Adolescent Study - Kinshasa

The Global Early Adolescent Study, Phase 2 | Kinshasa, Democratic Republic on the Congo

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03610568
Acronym
GEAS_KI
Enrollment
2862
Registered
2018-08-01
Start date
2017-06-20
Completion date
2022-12-31
Last updated
2023-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender Relations, Reproductive Health

Keywords

Gender Norms, Gender-Based Violence, Mental Health, Sexual & Reproductive Health, Adolescent Health

Brief 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.

Detailed 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:

Interventions

BEHAVIORALGrowing up GREAT! Intervention

The Growing up GREAT! intervention is built around the socio-ecological model. For young adolescents, a suite of materials provides information and prompts discussion about puberty, gender equality, healthy relationships, violence, and other related themes during weekly club sessions. For parents, group sessions featuring six testimonial videos foster discussion around non-violent parenting, equal sharing of household tasks, and girls' education. Other materials for teachers, health workers, and community members complement the core toolkit materials.

Sponsors

Save the Children
CollaboratorOTHER
Bill and Melinda Gates Foundation
CollaboratorOTHER
Georgetown University
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

1,400 adolescents were enrolled in the intervention group - 1,000 in-school and 400 out-of-school 1,400 adolescents were enrolled in the control group - 1,000 in-school and 400 out-of-school

Eligibility

Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* Males and females between the ages of 10-14 years of age * Lives within the geographic boundaries of Kimbanseke or Masina * Lives at home with a family (biological, adoptive, or foster) * Attends a school selected for the study INTERVENTION GROUP ONLY * Has indicated interest in participation in the after-school component of the intervention * Able to assent * Has obtained informed consent from a parent or guardian to participate in the study

Exclusion criteria

* Not between the ages of 10-14 * Does not live within the geographic boundaries of Kimbanseke or Masina * Is homeless or lives on the street * Attends a school not selected for the study, or does not attend school INTERVENTION GROUP ONLY * Attends a school selected for the study but has not indicated interest in participation in the after-school component of the intervention * Unable to assent * Has not obtained informed consent from a parent or guardian to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Contraceptive use as assessed by self-reported use at last sex from the Global Early Adolescent Study Questionnaire3 yearsChange in contraceptive prevalence among sexually active adolescents
Exposure to gender-based violence in the past 6 months as assessed by self-report from the Global Early Adolescent Study Questionnaire1 yearChange in reports of exposure to gender-based violence (GBV) at Wave II compared with baseline, sustained over subsequent waves of data collection.

Secondary

MeasureTime frameDescription
Gender-equitable attitudes and beliefs from the Global Early Adolescent Study Questionnaire3 yearsShift in self-reported gender-equitable attitudes and beliefs

Countries

Democratic Republic of the Congo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026