Adolescent BehaviorNCT03756467
Girl Empower: Studying the Impact of Mentorship, Asset Building, Caregiver Discussion Groups, and Cash Transfers on Reducing Girl's Vulnerability to Sexual Exploitation and Abuse
A study testing Girl Empower Program in people with Adolescent Behavior and Sexual Violence, run by Population Council at 1 site in Liberia.
Trial summary
Girl Empower (GE) is a program designed to equip girls with the skills and experiences necessary to make healthy, strategic life choices and to stay safe from sexual exploitation and abuse. Read more about this study
- Who is it for?
- Ages 13 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Sexual Violence
- What is being tested?
- Girl Empower Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteLiberia
- Study dates
- 12 Jul 2017to 31 Dec 2018
- 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 13 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, eligible girls aged 13 to 14 years of age.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Liberia1 site, 1 recruiting
- Recruiting
University of Liberia
Monrovia
Kelly Hallman, Ph.D., 212-339-0687, khallman@popcouncil.org
About this study
Girl Empower (GE) is a program designed to equip girls with the skills and experiences necessary to make healthy, strategic life choices and to stay safe from sexual exploitation and abuse.
Read the detailed description
The GE program is unique in its approach because it addresses girls' needs holistically. The girls' activities will take place in girl-only safe spaces located in their communities and contains the following components: Mentorship: girls have access to older female mentors. Mentors both provide weekly group-based and one-to-one interaction with girls as well as teach them critical skills; Asset building: Girls will have access to life skills and financial literacy training. This includes setting up savings accounts so girls practice their financial literacy skills, Monthly caregiver discussion groups among guardians of program girls, Capacity building and training of local health and psychosocial service providers to provide quality services to survivors of gender-based violence Intervention communities will either receive the GE program alone or the GE program with the plus small cash transfers to the girls' families as an incentive to attendance in weekly sessions (GE+).
- Conditions
- Adolescent Behavior, Sexual Violence
- Being tested
- Girl Empower Program
- Keywords
- Adolescent Behavior, Sexual Violence
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girl Empower ProgramBehavioural
Girl Empower (GE) encourages adolescent girls living in rural areas of Nimba County, Liberia to partake in weekly mentored community-based workshops on life skills, selfcare, and financial literacy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | 1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff |
| Arm 2 | Experimental | 1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff; and 3) savings account start-up Receives: Behavioral: Girl Empower Program |
| Arm 3 | Active comparator | 1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff; and 3) savings account start-up. Receives: Behavioral: Girl Empower Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Violence Index
The primary outcome of interest is an index of sexual violence at the individual level.
The index is composed of four questions in the endline survey instrument. The construction of the index, and a detailed description of its components is described in the pre-analysis plan (PAP) document uploaded under the "Analysis Plan" in this registration.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start12 Jul 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The impact evaluation study is a cluster-randomized controlled trial among 100 communities with three study arms: control (no intervention), GE, and GE+.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank, International Rescue Committee, City University of New York
- Responsible party
- Sponsor
- Investigators
- Kelly Hallman, Ph.D., Principal investigator, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756467
- Sponsor's protocol ID
- 645
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girl Empower: Studying the Impact of Mentorship, Asset Building, Caregiver Discussion Groups, and Cash Transfers on Reducing Girl's Vulnerability to Sexual Exploitation and Abuse
- ClinicalTrials.gov ID
- NCT03756467
- Acronym / sponsor ID
- 645
- Conditions
- Adolescent Behavior, Sexual Violence
- Keywords
- Adolescent Behavior, Sexual Violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- World Bank, International Rescue Committee, City University of New York
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Nov 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.
Girl Empower (GE) is a program designed to equip girls with the skills and experiences necessary to make healthy, strategic life choices and to stay safe from sexual exploitation and abuse.
Detailed description
The GE program is unique in its approach because it addresses girls' needs holistically. The girls' activities will take place in girl-only safe spaces located in their communities and contains the following components: Mentorship: girls have access to older female mentors. Mentors both provide weekly group-based and one-to-one interaction with girls as well as teach them critical skills; Asset building: Girls will have access to life skills and financial literacy training. This includes setting up savings accounts so girls practice their financial literacy skills, Monthly caregiver discussion groups among guardians of program girls, Capacity building and training of local health and psychosocial service providers to provide quality services to survivors of gender-based violence Intervention communities will either receive the GE program alone or the GE program with the plus small cash transfers to the girls' families as an incentive to attendance in weekly sessions (GE+).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The impact evaluation study is a cluster-randomized controlled trial among 100 communities with three study arms: control (no intervention), GE, and GE+.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff |
| Arm 2 | Experimental | Behavioral: Girl Empower Program1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff; and 3) savings account start-up |
| Arm 3 | Active comparator | Behavioral: Girl Empower Program1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff; and 3) savings account start-up. |
Who may qualify
- Ages
- 13 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy, eligible girls aged 13 to 14 years of age.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Girl Empower ProgramGirl Empower (GE) encourages adolescent girls living in rural areas of Nimba County, Liberia to partake in weekly mentored community-based workshops on life skills, selfcare, and financial literacy. | Behavioural | Arm 2, Arm 3 |
Primary outcome
Sexual Violence Index
Time frame: 40 weeks
The primary outcome of interest is an index of sexual violence at the individual level. The index is composed of four questions in the endline survey instrument. The construction of the index, and a detailed description of its components is described in the pre-analysis plan (PAP) document uploaded under the "Analysis Plan" in this registration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Kelly Hallman, Ph.D. principal investigator
Population Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Girl Empower Program in people with Adolescent Behavior and Sexual Violence, run by Population Council at 1 site in Liberia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Nov 2018. 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 Liberia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Hallman, Ph.D. (212-339-0687, khallman@popcouncil.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Violence Index (time frame: 40 weeks). 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 29 Nov 2018.