An Intervention to Reduce Risk Factors for Adolescent Pregnancy

NCT ID: NCT04222959

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-12-28

Brief 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."

Detailed 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 18 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= 9 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.

Conditions

Behavioral Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Girls Invest Intervention

Girls Invest intervention participants receive the app trainings and savings account with $100 deposited.

Group Type: EXPERIMENTAL

Girls Invest Intervention

Intervention Type: BEHAVIORAL

App-based trainings: The first 2 modules cover gender and cultural norms related to girls' social and economic empowerment, increasing girls' recognition of the importance of financial literacy and independence. The last 3 modules cover finance, educational loans, and employment.

Savings account: Participants receive $100 deposited into a savings account we set up for them, conditional upon completion of app-based trainings.

Wait-List Control Condition Participants

Control condition participants will be provided the Girls Invest intervention after the 6 month follow-up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Girls Invest Intervention

App-based trainings: The first 2 modules cover gender and cultural norms related to girls' social and economic empowerment, increasing girls' recognition of the importance of financial literacy and independence. The last 3 modules cover finance, educational loans, and employment.

Savings account: Participants receive $100 deposited into a savings account we set up for them, conditional upon completion of app-based trainings.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Reed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

San Diego State University

San Diego, California, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

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Other Identifiers

R21HD097496-01

Identifier Type: NIH

Identifier Source: org_study_id

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