- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03610568
Global Early Adolescent Study - Kinshasa (GEAS_KI)
The Global Early Adolescent Study, Phase 2 | Kinshasa, Democratic Republic on the Congo
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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
- 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:
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kinshasa, Congo, The Democratic Republic of the
- Kinshasa School of Public Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Growing 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contraceptive use as assessed by self-reported use at last sex from the Global Early Adolescent Study Questionnaire
Time Frame: 3 years
|
Change in contraceptive prevalence among sexually active adolescents
|
3 years
|
Exposure to gender-based violence in the past 6 months as assessed by self-report from the Global Early Adolescent Study Questionnaire
Time Frame: 1 year
|
Change in reports of exposure to gender-based violence (GBV) at Wave II compared with baseline, sustained over subsequent waves of data collection.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gender-equitable attitudes and beliefs from the Global Early Adolescent Study Questionnaire
Time Frame: 3 years
|
Shift in self-reported gender-equitable attitudes and beliefs
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Caroline Moreau, MD, PhD, MPH, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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