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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05258968
Other study ID # 5210395
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 17, 2022
Est. completion date May 30, 2022

Study information

Verified date October 2022
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Education on the Injeti Model of Self-Esteem
1 hour educational session

Locations

Country Name City State
United States Loma Linda University Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Self-Esteem 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
Primary Level of knowledge assessment 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. Change between 1 week Post educational session and 1 month post educational session.
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