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CompletedNCT03610568GEAS_KIUpdated Jan 5, 2023

Global Early Adolescent Study - Kinshasa

An interventional study of Growing up GREAT! Intervention in Gender Relations and Reproductive Health, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Congo, The Democratic Republic of the. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-05.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jun 2017, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
2,862
Allocation
Non-randomized
Ages
10 Years to 14 Years
Sex
All
01

Study 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.

Read the 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:

02

Conditions studied

  • Gender Relations
  • Reproductive Health

Keywords

  • Gender Norms
  • Gender-Based Violence
  • Mental Health
  • Sexual & Reproductive Health
  • Adolescent Health
03

In context

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 14 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,862 participants (actual)

Study arms

  • Experimental
    Growing up GREAT! Intervention

    Behavioral: Growing up GREAT! Intervention

  • No intervention
    Control

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.

06

What researchers measure

Primary outcomes

  1. Contraceptive use as assessed by self-reported use at last sex from the Global Early Adolescent Study Questionnaire

    Change in contraceptive prevalence among sexually active adolescents

    Time frame: 3 years

  2. Exposure to gender-based violence in the past 6 months as assessed by self-report from the Global Early Adolescent Study Questionnaire

    Change in reports of exposure to gender-based violence (GBV) at Wave II compared with baseline, sustained over subsequent waves of data collection.

    Time frame: 1 year

Secondary outcomes

  1. Gender-equitable attitudes and beliefs from the Global Early Adolescent Study Questionnaire

    Shift in self-reported gender-equitable attitudes and beliefs

    Time frame: 3 years

07

Study locations

1 site
  • Kinshasa School of Public Health
    Kinshasa, Congo, The Democratic Republic of the
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03610568
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Save the Children, Bill and Melinda Gates Foundation, Georgetown University
Responsible party
Sponsor
First posted
Aug 1, 2018
Start date
Jun 20, 2017
Primary completion
Nov 17, 2017
Completion
Dec 31, 2022
Last update
Jan 5, 2023

Study contacts

Caroline Moreau, MD, PhD, MPH
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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