Gender RelationsGEAS_KINCT03610568
Global Early Adolescent Study - Kinshasa
A study testing Growing up GREAT! Intervention in people with Gender Relations and Reproductive Health, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Relations, Reproductive Health
- What is being tested?
- Growing up GREAT! Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,862 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 20 Jun 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa
About this study
Official title: The Global Early Adolescent Study, Phase 2 | Kinshasa, Democratic Republic on the Congo
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.
Read the 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:
- Conditions
- Gender Relations, Reproductive Health
- Being tested
- Growing up GREAT! Intervention
- Keywords
- Gender Norms, Gender-Based Violence, Mental Health, Sexual & Reproductive Health, Adolescent Health
- Medical subject headings
- Psychological Well-Being, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growing up GREAT! InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Growing up GREAT! Intervention | Experimental | Not described Receives: Behavioral: Growing up GREAT! Intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
Gender-equitable attitudes and beliefs from the Global Early Adolescent Study Questionnaire
Shift in self-reported gender-equitable attitudes and beliefs
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start20 Jun 2017
- Primary completion17 Nov 2017
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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-school
- Masking
- None (open label)
- Enrolment
- 2,862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children, Bill and Melinda Gates Foundation, Georgetown University
- Responsible party
- Sponsor
- Investigators
- Caroline Moreau, MD, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610568
- Sponsor's protocol ID
- 7510
- Acronym
- GEAS_KI
- Status last verified
- Jan 2023
- First submitted
- 23 Jul 2018
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Global Early Adolescent Study, Phase 2 | Kinshasa, Democratic Republic on the Congo
- ClinicalTrials.gov ID
- NCT03610568
- Acronym / sponsor ID
- GEAS_KI / 7510
- Conditions
- Gender Relations, Reproductive Health
- Keywords
- Gender Norms, Gender-Based Violence, Mental Health, Sexual & Reproductive Health, Adolescent Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,862 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Save the Children, Bill and Melinda Gates Foundation, Georgetown University
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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-school
| Arm | Type | Receives |
|---|---|---|
| Growing up GREAT! Intervention | Experimental | Behavioral: Growing up GREAT! Intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growing up GREAT! InterventionThe 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. | Behavioural | Growing up GREAT! Intervention |
Primary outcome
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
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 secondary outcome
Gender-equitable attitudes and beliefs from the Global Early Adolescent Study Questionnaire
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Moreau, MD, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growing up GREAT! Intervention in people with Gender Relations and Reproductive Health, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive use as assessed by self-reported use at last sex from the Global Early Adolescent Study Questionnaire (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.