Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-07 @ 12:45 AM
Study NCT ID:
NCT04222959
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2020-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Intervention to Reduce Risk Factors for Adolescent Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ereed@sdsu.edu', 'phone': '508-212-1517', 'title': 'Elizabeth Reed', 'organization': 'San Diego State University Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'We collected adverse events throughout recruitment and follow-up, spanning 1.5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Girls Invest Intervention', 'description': '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)\n\nGirls Invest Mobile App Intervention: App-based trainings focused on financial and health literacy. Trainings included app features such as gaming dynamics, and quizzes. Each module estimates 25 minutes to complete.\n\nSavings Account Subsidies: Participants receive savings deposits upon completion of the app-based trainings.', 'otherNumAtRisk': 138, 'deathsNumAtRisk': 138, 'otherNumAffected': 0, 'seriousNumAtRisk': 138, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait-List Control Condition Participants', 'description': '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)', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sexual/Reproductive Health Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls Invest Intervention', 'description': 'Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey.\n\nGirls Invest Intervention includes 2 main components:\n\nGirls Invest Mobile App Trainings: 5 levels of training on financial and health topics\n\nSavings account and subsidies: Participants receive deposits into a savings account upon completion of app-based trainings, totaling $100.'}, {'id': 'OG001', 'title': 'Wait-List Control Condition Participants', 'description': 'Control condition participants were on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 month follow-up', 'description': 'Contraceptive use: Condom use and other contraception use and consistency of use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who reported having had sex in the past 6 months.'}, {'type': 'PRIMARY', 'title': 'Financial Reliance on a Male Partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls Invest Intervention', 'description': 'Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey.\n\nGirls Invest Intervention includes 2 main components:\n\nGirls Invest Mobile App Trainings: 5 levels of training on financial and health topics\n\nSavings account and subsidies: Participants receive deposits into a savings account upon completion of app-based trainings, totaling $100.'}, {'id': 'OG001', 'title': 'Wait-List Control Condition Participants', 'description': 'Control condition participants were on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Past 6 months', 'description': '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who were not lost to follow-up and responded to the item'}, {'type': 'SECONDARY', 'title': 'Feeling Depressed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls Invest Intervention', 'description': 'Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey.\n\nGirls Invest Intervention includes 2 main components:\n\nGirls Invest Mobile App Trainings: 5 levels of training on financial and health topics\n\nSavings account and subsidies: Participants receive deposits into a savings account upon completion of app-based trainings, totaling $100.'}, {'id': 'OG001', 'title': 'Wait-List Control Condition Participants', 'description': 'Control condition participants were on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months follow-up', 'description': '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)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were not lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Felt Worried, Tense, or Anxious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Girls Invest Intervention', 'description': 'Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey.\n\nGirls Invest Intervention includes 2 main components:\n\nGirls Invest Mobile App Trainings: 5 levels of training on financial and health topics\n\nSavings account and subsidies: Participants receive deposits into a savings account upon completion of app-based trainings, totaling $100.'}, {'id': 'OG001', 'title': 'Wait-List Control Condition Participants', 'description': 'Control condition participants were on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': '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)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were not lost to follow up and responded to questions regarding feelings of depression and anxiety at follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Girls Invest Intervention', 'description': '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)\n\nGirls 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'}, {'id': 'FG001', 'title': 'Wait-List Control Condition Participants', 'description': '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)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '138'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '62'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '76'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '28'}]}]}], 'typeUnitsAnalyzed': 'schools'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Girls Invest Intervention', 'description': '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)\n\nGirls 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'}, {'id': 'BG001', 'title': 'Wait-List Control Condition Participants', 'description': '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)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '17', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '17', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'We had some participants who did not respond to this question. Thus, the total analyzed is less than the full sample.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-17', 'size': 277806, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-27T19:01', 'hasProtocol': True}, {'date': '2022-09-13', 'size': 189674, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-29T15:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-01', 'studyFirstSubmitDate': '2020-01-07', 'resultsFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-01', 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual/Reproductive Health Behaviors', 'timeFrame': '6 month follow-up', 'description': 'Contraceptive use: Condom use and other contraception use and consistency of use.'}, {'measure': 'Financial Reliance on a Male Partner', 'timeFrame': 'Past 6 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Feeling Depressed', 'timeFrame': '6 months follow-up', 'description': '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)'}, {'measure': 'Felt Worried, Tense, or Anxious', 'timeFrame': '6 months', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavioral Changes']}, 'referencesModule': {'references': [{'pmid': '24518532', 'type': 'BACKGROUND', '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.'}, {'pmid': '28467193', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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."}, {'pmid': '26548549', 'type': 'BACKGROUND', '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.'}, {'pmid': '26271162', 'type': 'BACKGROUND', '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."}, {'pmid': '27488187', 'type': 'BACKGROUND', '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."}, {'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Schaner, S. (2017). The Persistent Power of Behavioral Change: Long-Run Impacts of Temporary Savings Subsidies for the Poor. Working paper'}, {'pmid': '29533047', 'type': 'BACKGROUND', '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. doi: 10.1257/aer.103.4.1138."}, {'pmid': '24275124', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23799008', 'type': 'BACKGROUND', '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.'}, {'pmid': '24974591', 'type': 'BACKGROUND', '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.'}, {'pmid': '24820518', 'type': 'BACKGROUND', '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.'}, {'pmid': '22256688', 'type': 'BACKGROUND', '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.'}, {'pmid': '24314113', 'type': 'BACKGROUND', 'citation': 'Curtin SC, Abma JC, Ventura SJ, Henshaw SK. Pregnancy rates for U.S. women continue to drop. NCHS Data Brief. 2013 Dec;(136):1-8.'}, {'pmid': '26971270', 'type': 'BACKGROUND', '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."}, {'pmid': '24393726', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22678305', 'type': 'BACKGROUND', '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.'}, {'pmid': '25649980', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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."', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 15-22 years old\n* literate in English\n* have a smart phone with internet access\n* have photo identification\n* willing to open a savings account'}, 'identificationModule': {'nctId': 'NCT04222959', 'briefTitle': 'An Intervention to Reduce Risk Factors for Adolescent Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls', 'orgStudyIdInfo': {'id': 'R21HD097496-01', 'link': 'https://reporter.nih.gov/quickSearch/R21HD097496-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Girls Invest Intervention', 'description': 'Girls Invest intervention participants receive the app trainings and savings account with $100 deposited.', 'interventionNames': ['Behavioral: Girls Invest Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-List Control Condition Participants', 'description': 'Control condition participants will be provided the Girls Invest intervention after the 6 month follow-up.'}], 'interventions': [{'name': 'Girls Invest Intervention', 'type': 'BEHAVIORAL', 'description': "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.\n\nSavings account: Participants receive $100 deposited into a savings account we set up for them, conditional upon completion of app-based trainings.", 'armGroupLabels': ['Girls Invest Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92182-1933', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elizabeth Reed', 'investigatorAffiliation': 'San Diego State University'}}}}