An Intervention to Reduce Risk Factors for Adolescent Pregnancy

Behavioral Changes Clinical Trial

Official title:

Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222959
• Other study ID #: R21HD097496-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2022
• Source: San Diego State University
• Contact: Elizabeth Reed, ScD
• Phone: 5082121517
• Email: ereed[@]sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators will assess the preliminary effects of Girls Invest, an innovative savings intervention that aims to reduce economic, social, and health behavior risks associated with disproportionately high rates of pregnancy among US Latina adolescents. Girls Invest involves a multidisciplinary conceptual model adapting the most effective prevention strategies from the disciplines of public health and economics. Participants receive a savings account (via our collaborating bank) with $100 deposited in increments based on completion of each module of a gender and life skills training via a mobile "app."

Description:

Investigators will assess the preliminary effects of Girls Invest, an innovative savings intervention that aims to reduce economic, social, and health behavior risks associated with disproportionately high rates of pregnancy among US Latina adolescents. Recommended models of adolescent pregnancy prevention in the US focus on modifying social norms (e.g., norms supporting early childbearing), as well as sexual health knowledge and skill-building; however, such efforts are not likely effective in reducing economic risk factors (e.g., financial reliance on male partners, low expectations for future career and educational achievements). Girls Invest involves a multidisciplinary conceptual model adapting the most effective prevention strategies from the disciplines of public health and economics to address social and economic risks associated with adolescent pregnancy. Participants receive a savings account (via our collaborating bank) with $100 deposited in increments based on completion of each module of a gender and life skills training via a mobile "app." Girls Invest will be evaluated among a community sample of Latina adolescents residing in economically disenfranchised neighborhoods in San Diego County with high rates of adolescent pregnancy. Adolescent pregnancy is a concern in San Diego and other US-Mexico border regions, where rates are higher compared to the rest of the US or elsewhere in Mexico. Compared to other racial/ethnic groups, Latina adolescents of Mexican origin have the highest pregnancy rates. In California, where Latinos constitute 39% of the population, 30% of all Latinas give birth prior to their 20th birthday. Latina adolescents ages 15-22 will be recruited among 16 community-based organizations and schools within low-income neighborhoods of San Diego County region. Half of the sites will be randomized to receive Girls Invest and the remaining assigned to a wait-list control condition (n= 8 sites per arm; total = 200 girls). To assess feasibility and fidelity, investigators will track (via data logs and app-based data) all aspects of recruitment, retention, and intervention completion. In-depth interviews with Girls Invest participants and focus groups with key stakeholders will inform acceptability and scalability of Girls Invest. Participants will complete a questionnaire at baseline and 6 months follow-up to assess evidence of improvements in intermediate outcomes. Regression analyses will assess treatment effects on intermediate outcomes. Investigators hypothesize that at follow-up, compared to control participants, Girls Invest participants will have reduced economic vulnerability (e.g., reduced financial reliance on male partners, improved expectations for future career and educational achievements), decreased social risks for pregnancy (e.g., intentions to delay pregnancy), and improved prioritization, knowledge of, and attitudes supportive of contraceptive use. Study findings will inform a full-scale efficacy trial of Girls Invest.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 22 Years

Eligibility

Inclusion Criteria:

• age 15-22 years old
• literate in English
• have a smart phone with internet access
• have photo identification
• willing to open a savings account

Related Conditions & MeSH terms

• Behavioral Changes

Intervention

Behavioral:
• Girls Invest Mobile App Intervention
Gender and life skills training: App-based trainings culturally tailored and adapted to this population using our formative work and based on elements from life skills trainings used in previous effective pregnancy prevention interventions among youth. We added sessions focused specifically on financial skill-building. Trainings included app features such as gaming dynamics, and quizzes. Each module estimates 25 minutes to complete. Training modules: The first 3 modules cover gender and cultural norms related to girls' social and economic opportunities, increasing girls' recognition of the importance of financial literacy, independence, and power in decision-making. The last 3 modules cover finance, educational loans, and employment.

Other:
• Savings Account Subsidies
Girls Invest builds upon two broadly accepted economic empowerment strategies: a) savings and b) cash transfers. The most promising economic empowerment interventions for girls have incorporated concrete economic resources along with training on life skills and gender.1-3 Trainings encourage girls to save additional funds (e.g. from family). Participants have online access and can withdraw savings anytime, however, we will assess savings behaviors to consider other account features (e.g. commitment-based savings). In the future, subsidies could be supported via ads in the app and financial support from banks.

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

References & Publications (20)

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Darney BG, Weaver MR, Sosa-Rubi SG, Walker D, Servan-Mori E, Prager S, Gakidou E. The Oportunidades conditional cash transfer program: effects on pregnancy and contraceptive use among young rural women in Mexico. Int Perspect Sex Reprod Health. 2013 Dec;39(4):205-14. doi: 10.1363/3920513. — View Citation

Dupas P, Robinson J. Why Don't the Poor Save More? Evidence from Health Savings Experiments. Am Econ Rev. 2013 Jun;103(4):1138-71. — View Citation

Gibbs A, Jacobson J, Kerr Wilson A. A global comprehensive review of economic interventions to prevent intimate partner violence and HIV risk behaviours. Glob Health Action. 2017 Jan - Dec;10(sup2):1290427. doi: 10.1080/16549716.2017.1290427. Review. — View Citation

Huang J, Kim Y, Sherraden M. Material hardship and children's social-emotional development: Testing mitigating effects of Child Development Accounts in a randomized experiment. Child Care Health Dev. 2017 Jan;43(1):89-96. doi: 10.1111/cch.12385. Epub 2016 Aug 4. — View Citation

Jennings L, Ssewamala FM, Nabunya P. Effect of savings-led economic empowerment on HIV preventive practices among orphaned adolescents in rural Uganda: results from the Suubi-Maka randomized experiment. AIDS Care. 2016;28(3):273-82. doi: 10.1080/09540121.2015.1109585. Epub 2015 Nov 7. — View Citation

Karimli L, Ssewamala FM. Do Savings Mediate Changes in Adolescents' Future Orientation and Health-Related Outcomes? Findings From Randomized Experiment in Uganda. J Adolesc Health. 2015 Oct;57(4):425-32. doi: 10.1016/j.jadohealth.2015.06.011. Epub 2015 Aug 11. — View Citation

LeBlanc AG, Chaput JP, McFarlane A, Colley RC, Thivel D, Biddle SJ, Maddison R, Leatherdale ST, Tremblay MS. Active video games and health indicators in children and youth: a systematic review. PLoS One. 2013 Jun 14;8(6):e65351. doi: 10.1371/journal.pone.0065351. Print 2013. Review. — View Citation

Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72. — View Citation

Martinez G, Copen CE, Abma JC. Teenagers in the United States: sexual activity, contraceptive use, and childbearing, 2006-2010 national survey of family growth. Vital Health Stat 23. 2011 Oct;(31):1-35. — View Citation

McDonald JA, Mojarro O, Sutton PD, Ventura SJ. Adolescent births in the border region: a descriptive analysis based on US Hispanic and Mexican birth certificates. Matern Child Health J. 2015 Jan;19(1):128-35. doi: 10.1007/s10995-014-1503-2. — View Citation

Minnis AM, Marchi K, Ralph L, Biggs MA, Combellick S, Arons A, Brindis CD, Braveman P. Limited socioeconomic opportunities and Latina teen childbearing: a qualitative study of family and structural factors affecting future expectations. J Immigr Minor Health. 2013 Apr;15(2):334-40. doi: 10.1007/s10903-012-9653-z. — View Citation

Minnis AM, vanDommelen-Gonzalez E, Luecke E, Dow W, Bautista-Arredondo S, Padian NS. Yo Puedo--a conditional cash transfer and life skills intervention to promote adolescent sexual health: results of a randomized feasibility study in san francisco. J Adolesc Health. 2014 Jul;55(1):85-92. doi: 10.1016/j.jadohealth.2013.12.007. Epub 2014 Feb 8. — View Citation

Reed E, Donta B, Dasgupta A, Ghule M, Battala M, Nair S, Silverman J, Jadhav A, Palaye P, Saggurti N, Raj A. Access to Money and Relation to Women's Use of Family Planning Methods Among Young Married Women in Rural India. Matern Child Health J. 2016 Jun;20(6):1203-10. doi: 10.1007/s10995-016-1921-4. — View Citation

Schaner, S. (2017). The Persistent Power of Behavioral Change: Long-Run Impacts of Temporary Savings Subsidies for the Poor. Working paper

Simons M, de Vet E, Brug J, Seidell J, Chinapaw MJ. Active and non-active video gaming among Dutch adolescents: who plays and how much? J Sci Med Sport. 2014 Nov;17(6):597-601. doi: 10.1016/j.jsams.2013.10.250. Epub 2013 Nov 9. — View Citation

Thaler, Richard, and Shlomo Benartzi. 2004. "Save More Tomorrow (TM): Using Behavioral Economics to Increase Employee Saving." Journal of Political Economy 112(S1): S164-S187.

Todd JE, Winters P, Stecklov G. Evaluating the impact of conditional cash transfer programs on fertility: the case of the Red de Protección Social in Nicaragua. Journal of Population Economics. 2012;25(1):267-290.

van Dommelen-Gonzalez E, Deardorff J, Herd D, Minnis AM. Homies with aspirations and positive peer network ties: associations with reduced frequent substance use among gang-affiliated Latino youth. J Urban Health. 2015 Apr;92(2):322-37. doi: 10.1007/s11524-014-9922-3. — View Citation

Vyas S, Watts C. How does economic empowerment affect women's risk of intimate partner violence in low and middle income countries? A systematic review of published evidence. Journal of international Development. 2009;21(5):577-602.

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual/Reproductive Health Behaviors	Contraceptive use: Condom use and other contraception use and consistency of use (past 3 months) Sexual Practices: Frequency of sexual activity (past 3 months)	Past 3 months
Primary	Economic Vulnerability	Self-reported perceptions of household economic stress (1 item, 5 pt Likert response, piloted by PI; greater values reflect more stress);access to own spending money (yes/no), and employment	Past 6 months
Primary	Social Risk Factors	Intimate partner violence (IPV): 12-items; revised Conflict Tactics Scale modified for use among adolescents.Knowledge to identify healthy versus unhealthy relationships (10 items developed by PI); Sexual relationship Power Scale (alpha = 0.84; higher scores reflect greater relationship power); Coercive sexual risk. e.g. "Has a male sex partner made you have sex without a condom even though you wanted to use one?" Additional items on control over decisions to: a) have sex and b) use contraception (if participant, partner, or both participant and partner decide)	Past 6 months