Behavioral ChangesNCT04222959
An Intervention to Reduce Risk Factors for Adolescent Pregnancy
A study testing Girls Invest Intervention in people with Behavioral Changes, run by San Diego State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Behavioral Changes
- What is being tested?
- Girls Invest Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 28 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 15-22 years old
- literate in English
- have a smart phone with internet access
- have photo identification
- willing to open a savings account
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182-1933
About this study
Official title: 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."
Read the 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
- Being tested
- Girls Invest Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girls Invest InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Girls Invest Intervention | Experimental | Girls Invest intervention participants receive the app trainings and savings account with $100 deposited. Receives: Behavioral: Girls Invest Intervention |
| Wait-List Control Condition Participants | No intervention | Control condition participants will be provided the Girls Invest intervention after the 6 month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual/Reproductive Health Behaviors
Contraceptive use: Condom use and other contraception use and consistency of use.
Measured: 6 month follow-up
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).
Measured: Past 6 months
Secondary outcomes (2)
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)
Measured: 6 months follow-up
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Dec 2021
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Behavioral ChangesStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Reed, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222959
- Sponsor's protocol ID
- R21HD097496-01
- Status last verified
- Nov 2024
- First submitted
- 7 Jan 2020
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24518532Gibbs 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.
PubMed 28467193Vyas 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.
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.
PubMed 26548549Karimli 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.
PubMed 26271162Huang 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.
PubMed 27488187Thaler, Richard, and Shlomo Benartzi. 2004. "Save More Tomorrow (TM): Using Behavioral Economics to Increase Employee Saving." Journal of Political Economy 112(S1): S164-S187.
Schaner, S. (2017). The Persistent Power of Behavioral Change: Long-Run Impacts of Temporary Savings Subsidies for the Poor. Working paper
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. doi: 10.1257/aer.103.4.1138.
PubMed 29533047Simons 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.
PubMed 24275124LeBlanc 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.
PubMed 23799008Martin 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.
PubMed 24974591McDonald 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.
PubMed 24820518Martinez 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.
PubMed 22256688Curtin SC, Abma JC, Ventura SJ, Henshaw SK. Pregnancy rates for U.S. women continue to drop. NCHS Data Brief. 2013 Dec;(136):1-8.
PubMed 24314113
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls
- ClinicalTrials.gov ID
- NCT04222959
- Acronym / sponsor ID
- R21HD097496-01
- Conditions
- Behavioral Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Girls Invest Intervention | Experimental | Behavioral: Girls Invest InterventionGirls Invest intervention participants receive the app trainings and savings account with $100 deposited. |
| Wait-List Control Condition Participants | No intervention | –Control condition participants will be provided the Girls Invest intervention after the 6 month follow-up. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- age 15-22 years old
- literate in English
- have a smart phone with internet access
- have photo identification
- willing to open a savings account
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Girls Invest InterventionApp-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. | Behavioural | Girls Invest Intervention |
Primary outcome
Sexual/Reproductive Health Behaviors
Time frame: 6 month follow-up
Contraceptive use: Condom use and other contraception use and consistency of use.
Financial Reliance on a Male Partner
Time frame: Past 6 months
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).
2 secondary outcomes
Feeling Depressed
Time frame: 6 months follow-up
Felt Worried, Tense, or Anxious
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24518532Minnis 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.
- Background: PubMed 28467193Gibbs 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.
- BackgroundVyas 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.
- Background: PubMed 26548549Jennings 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.
- Background: PubMed 26271162Karimli 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.
- Background: PubMed 27488187Huang 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.
- BackgroundThaler, Richard, and Shlomo Benartzi. 2004. "Save More Tomorrow (TM): Using Behavioral Economics to Increase Employee Saving." Journal of Political Economy 112(S1): S164-S187.
- BackgroundSchaner, S. (2017). The Persistent Power of Behavioral Change: Long-Run Impacts of Temporary Savings Subsidies for the Poor. Working paper
- Background: PubMed 29533047Dupas P, Robinson J. Why Don't the Poor Save More? Evidence from Health Savings Experiments. Am Econ Rev. 2013 Jun;103(4):1138-71. doi: 10.1257/aer.103.4.1138.
- Background: PubMed 24275124Simons 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.
- Background: PubMed 23799008LeBlanc 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.
- Background: PubMed 24974591Martin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Girls Invest Intervention in people with Behavioral Changes, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual/Reproductive Health Behaviors (time frame: 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04222959, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.