- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05258968
Injeti Self-Esteem Model and University Students
Effectiveness of the Injeti Self-Esteem Model (ISEM) for Improving Self-esteem Among University
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Pre-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.
Inclusion/Exclusion Criteria.
Participants 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.
Investigators 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.
The 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Loma Linda, California, United States, 92354
- Loma Linda University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages 18 - 35
- 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)
Exclusion Criteria:
- <18 or >35 years of age
- Does not meet student status
- Not fluent in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational Session on the Injeti Self Esteem Model
The participant will participate in a 1 hour educational session on the Injeti Self Esteem model.
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1 hour educational session
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-Esteem
Time Frame: Change between baseline and 2 weeks post educational session
|
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).
|
Change between baseline and 2 weeks post educational session
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Level of knowledge assessment
Time Frame: Change between 1 week Post educational session and 1 month post educational session.
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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.
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Change between 1 week Post educational session and 1 month post educational session.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Praveen Injeti, OTD, Loma Linda University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5210395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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