Global Early Adolescent Study - Kinshasa

NCT03610568 | Completed

• 1 other identifier: 7510
• Study Type: interventional
• Target: 2,862
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Relations; Reproductive Health

Keywords

Gender Norms; Gender-Based Violence; Mental Health; Sexual & Reproductive Health; Adolescent Health

Outcome Measures

Primary Outcomes (2)

• 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

  3 years

• 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.

  1 year

Secondary Outcomes (1)

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

  3 years

Study Arms (2)

Growing up GREAT! Intervention

EXPERIMENTAL

Behavioral: Growing up GREAT! Intervention

Control

NO INTERVENTION

Interventions

Growing up GREAT! Intervention 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.

Growing up GREAT! Intervention

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Save the Children: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Georgetown University: collaborator

Study Sites (1)

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Psychological Well-Being; Coitus

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Sexual Behavior

Study Officials

• Caroline Moreau, MD, PhD, MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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-school

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 1, 2018
• Study Start: June 20, 2017
• Primary Completion: November 17, 2017
• Study Completion: December 31, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)