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Global Early Adolescent Study - Kinshasa

NCT03610568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2862

Last updated 2023-01-05

No results posted yet for this 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.

Conditions

  • Gender Relations
  • Reproductive Health

Interventions

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.

Sponsors & Collaborators

  • Save the Children

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Georgetown University

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2017-11-17
Completion
2022-12-31

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03610568 on ClinicalTrials.gov