An Intervention to Reduce Risk Factors for Adolescent Pregnancy

October 6, 2022 updated by: Elizabeth Reed, San Diego State University

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

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."

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elizabeth Reed, ScD
  • Phone Number: 5082121517
  • Email: ereed@sdsu.edu

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92182-1933
        • Recruiting
        • San Diego State University
        • Contact:
          • Elizabeth Reed, ScD
          • Phone Number: 508-212-1517
          • Email: ereed@sdsu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 22 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Girls Invest Intervention
Girls Invest intervention participants will have been randomized to receive the intervention immediately upon completion of the baseline survey. Intervention participants will also complete the 6 month follow-up survey. (n=50 dyads; 100 total participants)
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.
NO_INTERVENTION: Wait-List Control Condition Participants
Control condition participants will be randomized upon completion of the baseline survey and put on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey. (n=50 dyads; 100 total participants)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual/Reproductive Health Behaviors
Time Frame: Past 3 months
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
Economic Vulnerability
Time Frame: Past 6 months
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
Social Risk Factors
Time Frame: Past 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

August 31, 2023

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (ACTUAL)

January 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • R21HD097496-01 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Behavioral Changes

Clinical Trials on Girls Invest Mobile App Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe