Condition category
Not Applicable
Date applied
27/05/2019
Date assigned
11/06/2019
Last edited
06/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Opening Futures (OF) is a mentoring intervention that aims to improve the living conditions of Mayan adolescent girls (AGs) through the implementation of the Population Council’s safe spaces model. In the AF program, girls meet on a weekly basis with trained mentors to learn about different topics and engage in recreational activities with their peers. The overarching objective that guides the work of AF is to strengthen the repertoire of life skills, promote empowerment, and contribute to improvements in the quality of life for disadvantaged indigenous AGs aged 11-17 years that participate in an innovative girl-centered pilot program in Mexico. Yucatan was chosen as the geographic setting for AF because of the poor socio-economic and health outcomes experienced particularly by indigenous girls and adolescents in the area. The researchers believe that through girls’ programming, they can contribute to building self- reliant communities by offering girls skills to increase their chances to succeed. With a population of 2.1 million, Yucatan has one of the highest proportions of indigenous people in Mexico (59%). Indigenous communities in Mexico live on the margins of Mexican society, therefore the challenges are vast, particularly for indigenous children and adolescents (who comprise 50% of all children in the state). The OF program approach is developed on an evidence-based design that allows for replicability and scale-up. OF is constructed on the knowledge that young adolescent girls are agents of social change and strategic investments in them directly support the achievement of local and national development goals. The aim of this study is to explore the potential effects of the program on school retention, child marriage, adolescent pregnancy, and other protective assets.

Who can participate?
All girls aged 11-17 years living in the communities selected for the intervention

What does the study involve?
Eight communities are allocated to the intervention group and three communities with similar characteristics served as the control group. The intervention group receive the OF intervention which has 6 modules covering about 12 weeks each. Household surveys collected at the start, middle and end of the study are used to measure the program's impact on the primary outcomes: adolescent pregnancy and school retention. The control group do not receive any interventions during the study but workshops are offered to them after the last survey is carried out.

What are the possible benefits and risks of participating?
The possible benefits of participating are that mentors, girls and adolescent girls could improve their repertoire of life skills and knowledge, promoting empowerment and contributed to their quality of life. Additionally, girls and adolescent girls learn, through trained mentors, about different topics and engage in recreational activities with their peers. One of the potential undesirable effects of the program could be an increase in intra-family violence exerted by male family members or inter-partner violence due to an increase in life skills of girls and adolescent girls. Although this is a risk that was considered, it was not reported by girls and adolescent girls participating in the program. Another risk was that girls and adolescent girls may have felt uncomfortable with some of the topics that were discussed during the sessions. They were told since the beginning of the program that they could leave the session at any time without penalty or loss of any other benefits.

Where is the study run from?
Cantamayec, Chacsinkin, Cholul, Mani, Mayapan, Teabo, Tipikal, Tixmehuac, Chankom, Chikindzonot, and Tixcacalcupul (Mexico)

When is the study starting and how long is it expected to run for?
March 2015 to July 2017

Who is funding the study?
W.K. Kellogg Foundation

Who is the main contact?
1. Mrs Isabel Vieitez
ivieitez@popcouncil.org
2. Miss Silvana Larrea Schiavon
slarrea@popcouncil.org

Trial website

Contact information

Type

Public

Primary contact

Mrs Isabel Vieitez

ORCID ID

Contact details

Avenida Miguel Ángel de Quevedo 578-2
Colonia: Santa Catarina
Municipality: Coyoacán
Mexico City
04010
Mexico
+52 (0)5559998630
ivieitez@popcouncil.org

Type

Public

Additional contact

Miss Silvana Larrea Schiavon

ORCID ID

Contact details

Avenida Miguel Ángel de Quevedo 578-2
Colonia: Santa Catarina
Municipality: Coyoacán
Mexico City
04010
Mexico
+52 (0)5559998630
slarrea@popcouncil.org

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Opening Futures: a mentoring intervention to improve life skills and sexual and reproductive health outcomes for rural and peri-urban indigenous adolescent girls in Yucatan, Mexico

Acronym

Opening Futures

Study hypothesis

Does exposing rural and peri-urban indigenous girls to a mentoring intervention improve outcomes related to education, life skills and sexual and reproductive health in Yucatan, Mexico?

Ethics approval

Approved 11/03/2015, Population Council Ethics Committee (1230 York Avenue. New York, NY 10065; Tel: +1 (0)212 327 7112; Email: ngontarz@popcouncil.org), Protocol No. 695

Study design

Quasi-experimental non-randomized control trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Livelihoods and sexual and reproductive health

Intervention

This study features a quasi-experimental non-randomized control trial design that measures the impact of a mentoring, safe spaces and life skills curriculum intervention designed to change knowledge, attitudes and behavior that improve favorable outcomes for rural and peri-urban indigenous girls in Yucatan, Mexico. For this, 8 communities were assigned to the intervention and 3 communities with similar characteristics served as control.

Opening Futures is an intervention that seeks to provide mentoring and create safe spaces where rural indigenous adolescent girls in the southern state of Yucatan, Mexico, can be empowered and taught to think critically. In the program, girls meet on a weekly basis with trained mentors to learn about different topics and engage in recreational activities with their peers. The intervention had 6 modules covering about 12 weeks each. The overarching objective that guides the work is to strengthen the repertoire of life skills, promote empowerment, and contribute to improvements in the quality of life for indigenous adolescent girls aged 11-17 years that participate in an innovative girl-centered pilot program in communities with low development index in Yucatan, Mexico.

Household surveys collected at baseline, midline and endline were used to measure the program's impact on the primary outcomes: adolescent pregnancy and school retention. To evaluate changes associated with the program the researchers conducted a propensity score matching (PSM) to generate unbiased estimates of a program’s average treatment effect on the treated (ATT).

The three control groups did not recieve any interventions during the time Abriendo Futuros was being piloted and evaluated in the eight intervention communities. However, after the endline household survey was carried out, workshops were offered to girls and adolescent girls living in the control communities.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Teen pregnancy measured as the percentage of girls that were or had been pregnant using household surveys at 18 months (endline)
2. Education: school dropout measured as the percentage of girls that were enrolled in the current school year using household surveys at 18 months (endline)

Secondary outcome measures

1. Financial literacy measured at 18 months (endline) with the following indicators:
1.1. Percentage of girls that reported having savings in the past three months
1.2. Percentage of girls that identified formal institutions (e.g. banks) as places where girls can save money
2. Attitudes towards gender norms measured at 18 months (endline) with the following indicators and Index:
2.1. Ideal age for first marriage
2.2. Desirable age at which to give birth to a first child
2.3. Ideal number of children
2.4. Gender Equitable Attitudes Scale, which measures the degree to which respondents agree with statements presenting gender equitable or inequitable positions on topics ranging from the division of domestic tasks, fidelity and physical violence between couples, economic contributions to the household, among others. High scores on the scale are associated with more gender-equitable attitudes, lower scores with less gender-equitable attitudes.
3. Sexual and Reproductive Health Knowledge (SRH) measured at 18 months (endline) with the following indicators and Indexes:
3.1. Percentage of girls exposed to sexual education at school on sexuality/women's bodies, how girls become women, sexual relationships between men and women, and how women get pregnant
3.2. Puberty and Development Knowledge Index: constructed by adding the number of correct responses to the questions listed below: when girls become women, do they: grow in height, change in weight, grow breasts, grow public hair, menstruate, and experience hormonal changes.
3.3. The Family Planning Knowledge Index: measures girls’ ability to correctly identify modern family planning methods, the index takes values between 0-10, girls are awarded one point for each modern method named in response to the question “what methods do you know for preventing pregnancy?” Girls who report knowing no family planning methods are automatically awarded a value of “0” on this variable.
3.4. The Pregnancy Knowledge Index: an additive score generated by summing the number of correct answers girls provided to the following questions: can a girl get pregnant the first time she has sex, can a girl get pregnant if a man withdraws before ejaculating, can a girl get pregnant if she has sex while she is in the middle of her menstrual cycle.
3.5. The Sexually Transmitted Infections (STIs) Knowledge Index: takes values between 0-1, girls are awarded one point when they provide a correct answer to the question “what methods do you know for preventing STIs?” Girls who report knowing no family planning methods are automatically awarded a value of “0” on this variable.
3.6. The HIV Knowledge Index: measures girls’ knowledge of HIV; the index takes values between 0-1, girls are awarded one point if they correctly answer the question: “can HIV/AIDS be cured?”
4. Social capital measured at 18 months (endline) with the Social Capital Index constructed by adding the following indicators: respondent has friends her own age outside the household, respondent met friends her own age outside the household last week, respondent identifies a mentor, respondent identifies a person who would provide her with a loan during an emergency, and respondent identifies a place where she could sleep during an emergency.
5. Exposure to violence measured at 18 months (endline) with the Exposure to Violence Index constructed by adding the variables listed below: In the past 12 months has a member of your household: shoved you, shaken you, or thrown something at you, slapped you or hit you in the face, twisted your arm or pulled your hair, kicked you or dragged you, tried to burn you, hit you with a shoe, belt, or other hard object.

Overall trial start date

01/03/2015

Overall trial end date

01/07/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All girls aged 11-17 years living in the communities selected for the intervention

Participant type

All

Age group

Other

Gender

Female

Target number of participants

60 girls in each community for a total of 660 participants

Participant exclusion criteria

1. Boys
2. Girls under the age of 11 years or over the age of 17 years

Recruitment start date

01/06/2015

Recruitment end date

01/06/2017

Locations

Countries of recruitment

Mexico

Trial participating centre

Casa Ejidal
Street 28 between 23 and 25. Colonia: Centro
Maní, Yucatán
97851
Mexico

Trial participating centre

Centro del DIF
Street 21 between 20 and 18 Colonia: Centro
Mayapán, Yucatán
97908
Mexico

Trial participating centre

Salón del Chaykan
Street 32 between 29 and 31-A
Teabo, Yucatán
97910
Mexico

Trial participating centre

Casa de Huéspedes
Street 18 between 19 and 21 Colonia: Centro
Chacsinkín, Yucatán
97955
Mexico

Trial participating centre

Casa de la Cultura
Street 21 between 16 and 19 Colonia: Centro
Tixméhuac, Yucatán
97950
Mexico

Trial participating centre

Dispensario Médico
Street 11
Cholul, Yucatán
97305
Mexico

Trial participating centre

Auditorio del DIF
Street 22 between 19 and 21 Colonia: Centro
Cantamayec, Yucatán
97915
Mexico

Trial participating centre

Casa Ejidal
Street 24 Colonia: Centro
Tipikal, Yucatán
97851
Mexico

Sponsor information

Organisation

Population Council Inc.

Sponsor details

One Dag Hammarskjold Plaza
New York
10017
United States of America
+1 (0)212 339 0619
ivieitez@popcouncil.org

Sponsor type

Other

Website

www.popcouncil.org

Funders

Funder type

Industry

Funder name

W.K. Kellogg Foundation

Alternative name(s)

WKKF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United States of America

Results and Publications

Publication and dissemination plan

Analysis was completed in December 2018. A manuscript will be submitted to a peer-reviewed journal in September 2019.

IPD sharing statement
The datasets generated during and/or analysed during the current study are being stored in a non-publically available repository. The repository is the Population Council OneDrive Mexico Office account. The type of data that will be shared will be the results obtained from the endline household surveys: 1) demographic characteristics of respondents, and 2) results obtained in the following areas: education, financial literacy, gender norms, sexual and reproductive health knowledge, social capital, and exposure to violence. The data will become available when the manuscript for the peer-reviewed journal is accepted and published. Consent forms were obtained from girls and adolescent girls, as well as for their parents or tutors, both for their participation in the Abriendo Futuros program as for the gathering of data for the baseline, midline, and endline surveys. Personal data of participants was anonymized and a unique ID was assigned to each of the participants and households.

Intention to publish date

30/09/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/06/2019: Trial's existence confirmed by ethics committee.