Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-01 @ 4:44 PM
Study NCT ID:
NCT05258968
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2022-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injeti Self-Esteem Model and University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'University students will be recruited to participate in 1 educational session on the Injeti Self Esteem Model.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Self-Esteem', 'timeFrame': 'Change between baseline and 2 weeks post educational session', 'description': 'The Rosenberg Self Esteem Scale is a10-item self-reported questionnaire designed to measure self-esteem. It includes 10 statements related to a person\'s feelings of self-worth or self-acceptance. A four-point scale ranging from "strongly agree" to "strongly disagree" is used to answer the questions (Rosenberg Self-Esteem Scale, n.d). The RSES is a reliable instrument as indicated by its Guttman scale coefficient of reproducibility of 0.92, which indicates excellent internal consistency. Test-retest reliability has correlations of 0.85 and 0.88 over a 2-week period, which indicates appropriate stability. The validity of the RSES is demonstrated by its concurrent, predictive, and constructive validity using known groups. The RSES correlates significantly with other measures of self-esteem such as the Coopersmith Self-Esteem Inventory as well as with the predicted direction of measures of depression and anxiety (Rosenberg, 2006).'}, {'measure': 'Level of knowledge assessment', 'timeFrame': 'Change between 1 week Post educational session and 1 month post educational session.', 'description': 'This semi-structured 15 minute interview will be completed after the educational session on the ISEM at two different time periods to gain an understanding of the participants perspective of how the knowledge has or has not been beneficial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self Esteem', 'Relationships', 'University students'], 'conditions': ['Self Esteem']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the effectiveness of the Injeti Self-Esteem Model (ISEM) with a psychoeducational therapy intervention for improving self-esteem among university students. To explore the effectiveness of the ISEM (see Appendix A), investigators are utilizing a mixed method study design to acquire both quantitative and qualitative data to view effectiveness through measurable outcomes and personal experience. The intervention will involve a 1-hour session, which will include administration of the ISEM.', 'detailedDescription': 'To explore the effectiveness of the ISEM investigators are utilizing a mixed-method study design to acquire both quantitative and qualitative data to view effectiveness through measurable outcomes and personal experience. Quantitative data will be gathered through standardized assessments, questionnaires, and demographic information. Qualitative information will be gathered through two interviews.\n\nPre-intervention data collection will include a Demographic Questionnaire, Rosenberg Self-Esteem Scale (RSES), and the Adverse Childhood Experience Questionnaire (ACE). The intervention itself will involve a 50-minute session consisting of the administration of the ISEM. All researchers will be trained to administer the ISEM by the Principal Investigator. After the intervention, data collection will involve two semi-structured interviews (SSI 1 and 2) that each require a completion of the RSES.\n\nInclusion/Exclusion Criteria.\n\nParticipants will include up to 150 students from varying universities throughout the Inland Empire ranging from 18-35 years of age. Participants must currently be enrolled as full-time or part-time students in an undergraduate or graduate program. English fluency in all areas (reading, writing, speaking, comprehension) will be required from all participants.\n\nInvestigators will recruit from each of the eight schools at Loma Linda University who have provided a signed Letter of Agreement (see Appendix B) using digital flyers via email communication. We will also recruit via snowballing.\n\nThe instruments we will use to collect data will include a Demographic Questionnaire, the Rosenberg Self-Esteem scale, the Adverse Childhood Experiences Questionnaire for Adults, and semi-structured interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 - 35\n* Must currently be enrolled as full-time or part-time students in an undergraduate or graduate program.\n* English fluency in all areas (reading, writing, speaking, comprehension)\n\nExclusion Criteria:\n\n* \\<18 or \\>35 years of age\n* Does not meet student status\n* Not fluent in English'}, 'identificationModule': {'nctId': 'NCT05258968', 'briefTitle': 'Injeti Self-Esteem Model and University Students', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Effectiveness of the Injeti Self-Esteem Model (ISEM) for Improving Self-esteem Among University', 'orgStudyIdInfo': {'id': '5210395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Session on the Injeti Self Esteem Model', 'description': 'The participant will participate in a 1 hour educational session on the Injeti Self Esteem model.', 'interventionNames': ['Other: Education on the Injeti Model of Self-Esteem']}], 'interventions': [{'name': 'Education on the Injeti Model of Self-Esteem', 'type': 'OTHER', 'description': '1 hour educational session', 'armGroupLabels': ['Educational Session on the Injeti Self Esteem Model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Praveen Injeti, OTD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'After data collection.', 'ipdSharing': 'YES', 'description': 'Information shared would relate to de-identified data analyzed for publication with our fellow researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}