GEAS_KI: Global Early Adolescent Study - Kinshasa

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03610568
Collaborator
Save the Children (Other), Bill and Melinda Gates Foundation (Other), Institute for Reproductive Health, Georgetown University (Other)
2,862
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2
66.4
43.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Growing up GREAT! Intervention
N/A

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:

Study Design

Study Type:
Interventional
Actual Enrollment :
2862 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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-school1,400 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
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Global Early Adolescent Study, Phase 2 | Kinshasa, Democratic Republic on the Congo
Actual Study Start Date :
Jun 20, 2017
Actual Primary Completion Date :
Nov 17, 2017
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Growing up GREAT! Intervention

Behavioral: 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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Contraceptive use as assessed by self-reported use at last sex from the Global Early Adolescent Study Questionnaire [3 years]

    Change in contraceptive prevalence among sexually active adolescents

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

Secondary Outcome Measures

  1. Gender-equitable attitudes and beliefs from the Global Early Adolescent Study Questionnaire [3 years]

    Shift in self-reported gender-equitable attitudes and beliefs

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 14 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kinshasa School of Public Health Kinshasa Congo, The Democratic Republic of the

Sponsors and Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • Save the Children
  • Bill and Melinda Gates Foundation
  • Institute for Reproductive Health, Georgetown University

Investigators

  • Principal Investigator: Robert Wm Blum, MD, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT03610568
Other Study ID Numbers:
  • 7510
First Posted:
Aug 1, 2018
Last Update Posted:
Aug 31, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins Bloomberg School of Public Health

Study Results

No Results Posted as of Aug 31, 2021