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An Intervention to Reduce Risk Factors for Adolescent Pregnancy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04222959
Enrollment
240
Registered
2020-01-10
Start date
2021-12-01
Completion date
2023-12-28
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral Changes

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.

Interventions

BEHAVIORALGirls 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.

Sponsors

San Diego State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 22 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sexual/Reproductive Health Behaviors6 month follow-upContraceptive use: Condom use and other contraception use and consistency of use.
Financial Reliance on a Male PartnerPast 6 monthsNumber of participants reporting relying financially on a male partner (reported to receive spending money from a male partner or reported that a male partner buys basic necessities, such as: food, clothing, school supplies).

Secondary

MeasureTime frameDescription
Feeling Depressed6 months follow-upFelt down, depressed, or hopeless - 5 pt likert scale recategorized as reporting any frequency of these feelings in last 30 days versus none (assessed at 6 months follow up)
Felt Worried, Tense, or Anxious6 monthsFelt worried, tense, or anxious - 5 pt likert scale recategorized as any frequency of these feelings in the past 30 days versus no days reporting these feelings (assessed at 6 months follow-up)

Countries

United States

Participant flow

Participants by arm

ArmCount
Girls Invest Intervention
Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey. Intervention participants will also complete the 6 month follow-up survey. (n=217 total participants) Girls Invest Mobile App Intervention: 5 levels of training on financial and health literacy Savings account and subsidies: participants receive deposits into a savings account upon completion of app-based trainings
138
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)
102
Total240

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up7628

Baseline characteristics

CharacteristicWait-List Control Condition ParticipantsTotalGirls Invest Intervention
Age, Categorical
<=18 years
80 Participants169 Participants89 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
22 Participants71 Participants49 Participants
Age, Continuous17 years
STANDARD_DEVIATION 1.4
17 years
STANDARD_DEVIATION 1.2
17 years
STANDARD_DEVIATION 1.5
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants15 Participants10 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants30 Participants30 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
82 Participants150 Participants68 Participants
Race (NIH/OMB)
White
1 Participants10 Participants9 Participants
Region of Enrollment
United States
102 Participants240 Participants138 Participants
Sex: Female, Male
Female
102 Participants240 Participants138 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1380 / 102
other
Total, other adverse events
0 / 1380 / 102
serious
Total, serious adverse events
0 / 1380 / 102

Outcome results

Primary

Financial Reliance on a Male Partner

Number of participants reporting relying financially on a male partner (reported to receive spending money from a male partner or reported that a male partner buys basic necessities, such as: food, clothing, school supplies).

Time frame: Past 6 months

Population: participants who were not lost to follow-up and responded to the item

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Girls Invest InterventionFinancial Reliance on a Male Partner11 Participants
Wait-List Control Condition ParticipantsFinancial Reliance on a Male Partner12 Participants
Primary

Sexual/Reproductive Health Behaviors

Contraceptive use: Condom use and other contraception use and consistency of use.

Time frame: 6 month follow-up

Population: Participants who reported having had sex in the past 6 months.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Girls Invest InterventionSexual/Reproductive Health Behaviors24 Participants
Wait-List Control Condition ParticipantsSexual/Reproductive Health Behaviors17 Participants
Secondary

Feeling Depressed

Felt down, depressed, or hopeless - 5 pt likert scale recategorized as reporting any frequency of these feelings in last 30 days versus none (assessed at 6 months follow up)

Time frame: 6 months follow-up

Population: Participants who were not lost to follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Girls Invest InterventionFeeling Depressed5 Participants
Wait-List Control Condition ParticipantsFeeling Depressed14 Participants
Secondary

Felt Worried, Tense, or Anxious

Felt worried, tense, or anxious - 5 pt likert scale recategorized as any frequency of these feelings in the past 30 days versus no days reporting these feelings (assessed at 6 months follow-up)

Time frame: 6 months

Population: Participants who were not lost to follow up and responded to questions regarding feelings of depression and anxiety at follow-up.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Girls Invest InterventionFelt Worried, Tense, or Anxious8 Participants
Wait-List Control Condition ParticipantsFelt Worried, Tense, or Anxious27 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026