Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 6:43 AM
Study NCT ID:
NCT07447661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STEM As I Am Phase I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Mobile app to deliver culturally responsive role modeling and evidencebased instruction (modeling, practice, feedback) in the academic vocabulary, behaviors, and mindset that underlie STEM success.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Student Academic Vocabulary Word Meaning (SAVM)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'SAVM will measure change in student vocabulary knowledge (multiple choice test of meaning). The multiple choice test is based on the assessment used in Beck et al. (1982) and McKeown et al. (1983) with middle school students. Scores were computed as the total percentage of vocabulary words correctly identified out of 72. Score could range from 0 to 100 and higher scores indicate greater levels of vocabulary knowledge.'}, {'measure': 'Parent Academic Vocabulary Word Meaning (PAVM)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'PAVM will measure change in parent vocabulary knowledge (multiple choice test of meaning). The multiple choice test is based on the assessment used in Beck et al. (1982) and McKeown et al. (1983) with middle school students. Scores were computed as the total percentage of vocabulary words correctly identified out of 72. Score could range from 0 to 100 and higher scores indicate greater levels of vocabulary knowledge.'}, {'measure': 'Student Academic Vocabulary Word Usage (SAVWU)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'SAVWU will measure change in student ability to correctly use vocabulary words in sentence contexts. The sentence verification test is similar to the Test of Instructed Word Knowledge in Vocabulary used in the Apthorp et al. (2012) study of vocabulary learning in middle school. Scores were computed as the total percentage of vocabulary words correctly used in sentence context out of 72 items. Score could range from 0 to 100, and higher scores indicate greater levels of vocabulary words used correctly in a sentence.'}, {'measure': 'Parent Academic Vocabulary Word Usage (PAVWU)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'PAVWU will measure change in parent ability to correctly use vocabulary words in sentence contexts. The sentence verification test is similar to the Test of Instructed Word Knowledge in Vocabulary used in the Apthorp et al. (2012) study of vocabulary learning in middle school. Scores were computed as the total percentage of vocabulary words correctly used in sentence context out of 72 items. Score could range from 0 to 100 and higher scores indicate greater levels of vocabulary words used correctly in a sentence.'}, {'measure': 'Student Fixed Mindset (SFM)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'SFM is a four-item survey measure of fixed mindset. Student responds to statements about their beliefs about learning and intelligence. The measure uses a 6-point scale. The item scores are averaged into a single scale and can range from 1 to 6, with higher values corresondeing to more fixed mindsets. The measure has demonstrated reliability (Yeager et al., 2016).'}, {'measure': 'Student Academic Behaviors (SAB)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'SAB is a five-item survey measure of academic behaviors strongly linked to student success. Students respond to questions about how frequently they engage in these behaviors (e.g., turn in assignments on time). The measure uses a 5-point scale (1 = strongly disagree, 5 = strongly agree) and a mean score was computed and could range from 1 to 5. Higher scores indicated greater levels of perceived academic learning behaviors., and has demonstrated reliability (Snipes \\& Tran, 2016).'}], 'secondaryOutcomes': [{'measure': 'Student Academic Vocabulary Usage Behaviors (SAVUB)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'SAVUB will measure change in student use of SAV words (10 items). Items were adapted from: the Student Engagement Instrument (SEI; Betts, Appleton, Reschly, et al., 2010). Items used a 4-point response option (1 = not at all, 4 = 3-4 times per week) and a mean score and could range from 1 to 4. Higher scores indicated greater use of SAV words.'}, {'measure': 'Parent Academic Vocabulary Usage Behaviors (SAVUB)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'SAVUB will measure change in parent use of SAV words (10 items). Items were adapted from: the Student Engagement Instrument (SEI; Betts, Appleton, Reschly, et al., 2010). Items used a 4-point response option (1 = not at all, 4 = 3-4 times per week) and a mean score and could range from 1 to 4. Higher scores indicated greater use of SAV words.'}, {'measure': 'Student Confidence in using AV words (SCAV)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'SCAV will measure student confidence in using SAV words (10 items). Items were adapted from the Efficacy to Influence School-related Performance subscale of the Parental Self-Efficacy Scale (PSES; Bandura, et al., 2001). Items were developed using procedures for developing self-efficacy scales (Bandura et al., 2001). Items used a 5-point response option (1 = not at all confident, 5 = extremely confident) and a mean score was computed and could range from 1 to 5. Higher scores indicated greater confidence using SAV words.'}, {'measure': 'Parent Confidence in using AV words (PCAV)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': 'PCAV will measure parent confidence in using SAV words (10 items). Items were adapted from the Efficacy to Influence School-related Performance subscale of the Parental Self-Efficacy Scale (PSES; Bandura, et al., 2001). Items were developed using procedures for developing self-efficacy scales (Bandura et al., 2001). Items used a 5-point response option (1 = not at all confident, 5 = extremely confident) and a mean score was computed (alpha = .95) and could range from 1 to 5. Higher scores indicated greater confidence using SAV words.'}, {'measure': 'Student Interest in choosing STEM careers (STEM)', 'timeFrame': 'Baseline (pre-treatment) and 6 weeks (post-treatment)', 'description': "STEM will measure students' interest in STEM careers (4 items). Items were adapted from: the Student Engagement Instrument (SEI; Betts, Appleton, Reschly, et al., 2010) and the Efficacy to Influence School-related Performance subscale of the Parental Self-Efficacy Scale (PSES; Bandura, et al., 2001). Items used a 5-point response option (1 = not at all interested, 5 = extremely interested) and a mean score was computed and could range from 1 to 5. Higher scores indicated greater interest in using SAV words."}, {'measure': 'Student Technology Acceptance (STA) - Acceptability of Intervention (AIM)', 'timeFrame': '6-weeks after baseline (Post treatment)', 'description': 'Acceptability of Intervention Measure (AIM; 4-items) is a measure that often used in formative studies and are considered leading indicators of implementation success (Proctor et al., 2011; Bowen et al., 2009). Uses a 5-point response option, have demonstrated reliability, test-retest reliability, and shown to assess sensitivity to change (Weiner et al. 2017). A mean score will be computed and scores can range from 1 to 5. Higher scores indicate greater acceptability of the intervention.'}, {'measure': 'Student Technology Acceptance (STA) - Intervention Appropriateness Measure (IAM)', 'timeFrame': '6-weeks after baseline (Post treatment)', 'description': 'Intervention Appropriateness Measure (IAM; 4-items) is a measure that often used in formative studies and are considered leading indicators of implementation success (Proctor et al., 2011; Bowen et al., 2009). Uses a 5-point response option, have demonstrated reliability, test-retest reliability, and shown to assess sensitivity to change (Weiner et al. 2017). A mean score will be computed and scores can range from 1 to 5. Higher scores indicate greater approriateness of the intervention.'}, {'measure': 'Parent Technology Acceptance (PTA) - Acceptability of Intervention (AIM)', 'timeFrame': '6-weeks after baseline (post treatment)', 'description': 'Acceptability of Intervention Measure (AIM; 4-items) is a measure that often used in formative studies and are considered leading indicators of implementation success (Proctor et al., 2011; Bowen et al., 2009). Uses a 5-point response option, have demonstrated reliability, test-retest reliability, and shown to assess sensitivity to change (Weiner et al. 2017). A mean score will be computed and scores can range from 1 to 5. Higher scores indicate greater acceptability of the intervention.'}, {'measure': 'Parent Technology Acceptance (PTA) - Intervention Approriateness Measure (IAM)', 'timeFrame': '6-weeks after baseline (post treatment)', 'description': 'Intervention Appropriateness Measure (IAM; 4-items) is a measure that often used in formative studies and are considered leading indicators of implementation success (Proctor et al., 2011; Bowen et al., 2009). Uses a 5-point response option, have demonstrated reliability, test-retest reliability, and shown to assess sensitivity to change (Weiner et al. 2017). A mean score will be computed and scores can range from 1 to 5. Higher scores indicate greater approriateness of the intervention.'}, {'measure': 'Student Satisfaction with STEM-AIM Program', 'timeFrame': '6-weeks after baseline (post treatment)', 'description': 'Student satisfaction with the STEM-AIM program will be measured with 15 items that ask students to rate, on a 5-point Likert response scale, the degree to which the STEM-AIM features were helpful, useful, enjoyable, and met their expectations. A mean score will be computed and scores can range from 1 to 5. Higher scores indicate greater satisfaction with the program.'}, {'measure': 'Parent Satisfaction with STEM-AIM Program', 'timeFrame': '6-weeks after baseline (post treatment)', 'description': 'Parent satisfaction with the STEM-AIM program will be measured with 15 items that ask parents to rate, on a 5-point Likert response scale, the degree to which the STEM-AIM features were helpful, useful, enjoyable, and met their expectations. A mean score will be computed and scores can range from 1 to 5. Higher scores indicate greater satisfaction with the program.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Academic Support for Black Middle School Student Success in STEM']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Bandura, A., Barbaranelli, C., Caprara, G. V., & Pastorelli, C. (2001). Self-efficacy beliefs as shapers of children's aspirations and career trajectories. Child Development, 72, 187-206. http://dx.doi.org/10.1111/1467-8624.00273"}, {'pmid': '27524832', 'type': 'BACKGROUND', 'citation': "Yeager DS, Romero C, Paunesku D, Hulleman CS, Schneider B, Hinojosa C, Lee HY, O'Brien J, Flint K, Roberts A, Trott J, Greene D, Walton GM, Dweck CS. Using Design Thinking to Improve Psychological Interventions: The Case of the Growth Mindset During the Transition to High School. J Educ Psychol. 2016 Apr;108(3):374-391. doi: 10.1037/edu0000098."}, {'type': 'BACKGROUND', 'citation': 'McKeown, M. G., Beck, I. L., Omanson, R. C., & Perfetti, C. A. (1983). The Effects of Long-Term Vocabulary Instruction on Reading Comprehension: A Replication. Journal of Reading Behavior, 15(1), 3-18. https://doi.org/10.1080/10862968309547474 (Original work published 1983)'}, {'type': 'BACKGROUND', 'citation': 'Beck I. L., Mccaslin E. S., Mckeown M. G. The rationale and design of a program to teach vocabulary to fourth-grade students (LRDC Publication 1980/25). Pittsburgh: University of Pittsburgh, Learning Research and Development Center, 1980. Google Scholar Beck I. L., Omanson R. C., Mckeown M. G. An instructional redesign of reading lessons: Effects on comprehension. Reading Research Quarterly, 1982, 17, 462-481.'}, {'type': 'BACKGROUND', 'citation': 'Snipes, J., & Tran, L. (2016). Early Indicators and Academic Mindsets in the Clark County School District. Regional Educational Laboratory West.'}, {'type': 'BACKGROUND', 'citation': 'Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., . . . Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation science, 12(1), 108. doi:10.1186/s13012-017-0635-3'}, {'type': 'BACKGROUND', 'citation': 'Proctor, E., Silmere, H., Raghavan, R., Hovmand, P., Aarons, G., Bunger, A., . . . Hensley, M. (2011). Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Administration and Policy in Mental Health and Mental Health Services Research, 38(2), 65-76.'}, {'type': 'BACKGROUND', 'citation': 'Betts, J. E., Appleton, J. J., Reschly, A. L., Christenson, S. L., & Huebner, E. S. (2010). A study of the factorial invariance of the Student Engagement Instrument (SEI): Results from middle and high school students. School Psychology Quarterly, 25(2), 84.'}, {'pmid': '19362699', 'type': 'BACKGROUND', 'citation': 'Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.'}, {'type': 'BACKGROUND', 'citation': 'Apthorp, H., Randel, B., Cherasaro, T., Clark, T., McKeown, M., & Beck, I. (2012). Effects of a Supplemental Vocabulary Program on Word Knowledge and Passage Comprehension. Journal of Research on Educational Effectiveness, 5(2), 160-188. https://doi.org/10.1080/19345747.2012.660240'}]}, 'descriptionModule': {'briefSummary': 'Black students experience significant achievement gaps that contribute to underrepresentation in high paying STEM fields and disparity in health and economic outcomes. Effective middle-school interventions include exposure to culturally relevant STEM role models, instruction in academic behaviors and growth mindset, instruction in the academic vocabulary required to pass high stakes achievement tests, and support for family engagement. The goal of this proposal is to develop a media-enhanced technology that offers Black middle school students and their families a culturally responsive support tool for engaging in STEM learning in the home setting.', 'detailedDescription': "The feasibility test will consist of a 6-week intervention to assess the program's relevance, acceptability, cultural appropriateness, and potential for efficacy. The study will use a within-subjects pre-post design with 50 parent-student dyads to detect changes in student word knowledge, academic enabling behaviors, mindset, academic self-efficacy, and interest in STEM. Measures will also detect changes in parent word knowledge, use of AV words in the home, and self-efficacy with regard to AV use and academic support behaviors. Additionally, a post-test evaluation of consumer satisfaction, technology acceptability, and recommendations for modifications to the program will be administered to both students and their parents/guardians. Usage reports will be collected from the technology's backend system to measure frequency and duration of student and parent engagement with the technology components as well as numbers of correct/incorrect responses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. being the parent/guardian of a middle school student who identifies as Black/African American\n2. having a smartphone or tablet'}, 'identificationModule': {'nctId': 'NCT07447661', 'acronym': 'STEM AIM', 'briefTitle': 'STEM As I Am Phase I', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oregon Research Behavioral Intervention Strategies, Inc.'}, 'officialTitle': 'STEM As I Am: A Culturally Relevant Media-enhanced Tool for Engaging Black Middle School Students and Their Families in STEM', 'orgStudyIdInfo': {'id': 'MD020230'}, 'secondaryIdInfos': [{'id': '1R43MD020230-01', 'link': 'https://reporter.nih.gov/quickSearch/1R43MD020230-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STEM-AIM', 'description': 'The STEM-AIM app will provide students and their families with a media-enhanced learning experience. Videos will feature Black STEM heroes who describe their paths to STEM and the growth mindset skills that helped them overcome barriers and challenges. STEM heroes and near-peer vignettes introduce a set of academic vocabulary words that underlie STEM achievement. Users then practice drag and drop definition, spelling, and usage games.', 'interventionNames': ['Other: Technology-based educational intervention']}], 'interventions': [{'name': 'Technology-based educational intervention', 'type': 'OTHER', 'description': 'Mobile app to deliver culturally responsive role modeling and evidence-based instruction (modeling, practice, feedback) in the academic vocabulary, behaviors, and mindset that underlie STEM success.', 'armGroupLabels': ['STEM-AIM']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David R Smith, PhD', 'role': 'CONTACT', 'email': 'david.smith@influentsin.com', 'phone': '541-484-2123'}], 'overallOfficials': [{'name': 'David R Smith, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Research Behavioral Intervention Strategies, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Research Behavioral Intervention Strategies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}