GAGE Act With Her-Ethiopia Evaluation

Adolescent Behavior Clinical Trial

Official title:

Gender Transformative Programming to Improve Capabilities of Young Adolescents in Ethiopia: A Cluster Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03890237
• Other study ID #: GAGE AWH-E 2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the impact of Act With Her Ethiopia (AWH-E), a gender transformative multi-level program that aims to improve the lives of young adolescent boys and girls.

Description:

Unequal gender norms and power dynamics are often driven and reinforced by adolescent girls' male peers, families, communities, and the broader institutional structures that surround them. Without change in gender attitudes and norms at each of these levels, improved outcomes for key transitions are much less likely to be sustained. Efforts to nurture change must also acknowledge that adolescents' opportunities and capabilities are shaped by complex, intersectional forces including ethnicity, caste, religion, and disability, among others. This multi-arm randomized control trial aims to improve the evidence base on effective approaches to improve multi-sectoral outcomes for girls across the following domains from the Gender and Adolescence: Global Evidence (GAGE) framework: education and learning; health, nutrition and sexual and reproductive health; bodily integrity; psychosocial well-being; voice and agency; and economic empowerment.

Specifically, the trial has four goals:

1. To evaluate the impact of Act With Her in Ethiopia (AWH-E) - a gender-transformative multi-level program - on young adolescent girls' and boys' capabilities (11-13) in the short- and long-run across the six GAGE capability domains using a multi-arm cluster randomized control trial across two regions (Amhara and Oromia).

2. To compare the impact of AWH-E to a more basic gender-synchronized program (AWH-E without community engagement and systems strengthening), a standalone girls' group program (Her Spaces), and the gender-transformative program with economic support (AWH-E + Asset Transfers) on young adolescent capability achievements and transitions in the short- and longer- terms across two regions (Amhara and Oromia).

3. To evaluate the impact of AWH-E on young adolescent capability achievements and transitions in the short- and long- term in pastoralist contexts (Afar).

4. To use mixed-methods research to understand the mechanisms driving the impact, and in particular what works, for whom, and why.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

Inclusion Criteria:

• girls and boys 10-13 at time of enrollment in Act With Her Arms

• girls 11-13 female at time of enrollment in Her Spaces Arm

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Adolescent Behavior
• Gender

Intervention

Behavioral:
• Her Spaces
Her Spaces will comprise a set of activities leveraging the Her Spaces curriculum and program model which includes curriculum-based sessions for 11-13 year old girls, with 40 sessions delivered weekly over the course of 10 months
• Act With Her
Act With Her was designed to facilitate adolescent transitions to adulthood via improvements across the six GAGE domains (education, bodily integrity, health, psychosocial well-being, voice and agency, and economic empowerment). Project activities fall into three main categories: curriculum-based programming with adolescent girls and boys, community transformation, and systems strengthening. Act With Her will work with 10-13 year old girls and boys for 10 months and implement community-level and high-level system strengthening work up to 24 months (in rural and pastoralist areas).
• Act With Her + Asset Transfer
This arm will implement the Act With Her program described above, using program curricula with 10-13-year-old girls and boys over 10 months and conducting community-level systems strengthening up to 24 months. Additionally, the girls participating in this arm will receive one of three asset transfer options. The packages will be of equal value (115 USD) - one will include school supplies, one will include hygiene supplies, and will be a combination of both. Each adolescent girl will choose which package she would like to receive and will receive components of the package at 3 timepoints over the course of the first 10 months of the project.
• Act With Her (simple)
This arm will implement the Act With Her curricula described above with 10-13 year old girls and boys over 10 months. The adolescent groups will follow the same model (near-peer, same-sex mentors, 40 weekly meetings for girls, 18 meetings for boys, 4 of which are joint sessions for boys and girls, 6 sessions for parents), but will not include community-level systems strengthening activities

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
George Washington University	Addis Ababa University, Care International, Gates Foundation, Overseas Development Institute, Pathfinder International, UK Department for International Development on behalf of UK Aid, University of Oklahoma

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized Index of Education and Learning (girls)	Standardized index of education and learning at the individual level. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is comprised of four components: indicator for enrolled in school (at time in survey, or if school not in session at survey, at time of most recent session), share of school days attended (past two weeks; among those enrolled), indicator for did not miss more than one week of school at one time (past 12 months; among those enrolled), aspires for secondary degree or higher. The construction of the index, and a detailed description of its components is described in the protocol.	20 months after intervention starts
Primary	Standardized index of Bodily Integrity (girls)	Standardized index of bodily integrity at the individual level. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is comprised of six indicators: peer violence scale (past 12 months, inverse), indicator for did not experience peer violence (past 12 months), indicator for did not perpetrate peer violence (past 12 months), indicator for did not experience violence or witness violence against female caregiver in the household (past 12 months), indicator for did not experience sexual violence (past 12 months), ideal age of marriage. The construction of the index, and a detailed description of its components is described in the protocol.	20 months after the intervention starts
Primary	Standardized Index of Health, Nutrition, and Sexual and Reproductive Health (girls)	Standardized index of bodily integrity at the individual level. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is comprised of five components: indicator for self-reported health very good or good, proportion of meals yesterday with meat/chicken/fish/egg, indicator if ever hungry because not enough food (past four weeks), indicator for normal activities not affected during menstruation (among those who have reached menarche), index of improved menstrual hygiene practices (among those who have reached menarche), ideal age of first child (among childless). The construction of the index, and a detailed description of its components is described in the protocol.	20 months after the intervention starts
Primary	Standardized Index of Psychosocial Well-Being (girls)	Standardized index of bodily integrity at the individual level. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is composed of three components. Rosenberg Self Esteem Scale score, General Health Questionnaire-12 (GHQ-12; measure of psychosocial distress; inverse) score, Child and Youth Resilience Scale score. The construction of the index, and a detailed description of its components is described in the protocol	20 months after the intervention starts
Primary	Standardized Index of Voice and Agency (girls)	Standardized index of voice and agency. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. The index is composed of five components: index of participation in decision making (school, family; standardized separately for in school and out of school), index of comfort discussing issues, index of voice, index of mobility, index of collective action. The construction of the index, and a detailed description of its components is described in the protocol.	20 months after the intervention starts
Primary	Standardized Index of Economic Empowerment (girls)	Standardized index of economic empowerment. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. Index is comprised of five components: indicator for any control of money (past 12 months), indicator for any savings for the future, indicator for aspires to be employed in skilled or professional work when adult, aspires to have employment or a business when adult, proportion of time yesterday in leisure and school (including travel to and from, and studying). The construction of the index, and a detailed description of its components is described in the protocol.	20 months after the intervention starts
Primary	Standardized Index of Cross-Cutting Gender Issues (girls)	Standardized index of cross-cutting gender issues. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. Index is comprised of six components: index of gender equitable attitudes, index of gender consciousness, index of trusted friends (supportive social network), indicator for supportive adult, knowledge index, index of access to health services. The construction of the index, and a detailed description of its components is described in the protocol.	20 months after the intervention ends
Primary	Standardized Index of Cross-Cutting Gender Issues (boys)	Standardized index of cross-cutting issues for boys. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. Index of composed of 9 components: index of gender equitable attitudes, index of gender consciousness, index of gender equitable behaviors, indicator for not perpetrating peer violence, peer violence index (inverse), indicator for not being a victim of peer violence, General Health Questionare-12 (GHQ-12; measure of mental health, inverse) score, indicator for supportive adult, knowledge index. The construction of the index, and a detailed description of its components is described in the protocol	20 months after the intervention ends
Primary	Standardized Index of Cross-cutting Gender Issues (primary female caregivers of girls)	Standardized index of cross-cutting issues for primary female caregivers of girls. The index is standardized to be mean 0 standard deviation 1. Higher values are better outcomes. Each component of the index is also standardized to be mean zero standard deviation one before summing. Index consists of 8 components: aspiration for adolescent's education, expected age of marriage for adolescent, aspiration for adolescent to work in skilled or professional employment as an adult, aspiration for adolescent to be employed or own a business as an adult, index of support for education, indicator for did not cut back food same for boys and girls (past 4 weeks), index of gender consciousness, index of gender attitudes. The construction of the index, and a detailed description of its components is described in the protocol	20 months after the intervention ends