Global Early Adolescent Study - Kinshasa

NCT ID: NCT03610568

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2022-12-31

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:

Conditions

Gender Relations; Reproductive Health

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Growing up GREAT! Intervention

Group Type: EXPERIMENTAL

Growing up GREAT! Intervention

Intervention Type: BEHAVIORAL

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Save the Children

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Moreau, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Kinshasa School of Public Health

Kinshasa, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

Other Identifiers

7510

Identifier Type: -

Identifier Source: org_study_id