Self EsteemNCT05258968
Injeti Self-Esteem Model and University Students
A study testing Education on the Injeti Model of Self-Esteem in people with Self Esteem, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Esteem
- What is being tested?
- Education on the Injeti Model of Self-Esteem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- <18 or >35 years of age
- Does not meet student status
- Not fluent in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Injeti Self-Esteem Model (ISEM) for Improving Self-esteem Among University
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.
Read the 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.
- Conditions
- Self Esteem
- Being tested
- Education on the Injeti Model of Self-Esteem
- Keywords
- Self Esteem, Relationships, University students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on the Injeti Model of Self-EsteemOther
1 hour educational session
| Study group | Role | What they receive |
|---|---|---|
| Educational Session on the Injeti Self Esteem Model | Experimental | The participant will participate in a 1 hour educational session on the Injeti Self Esteem model. Receives: Other: Education on the Injeti Model of Self-Esteem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change between baseline and 2 weeks post educational session
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.
Measured: Change between 1 week Post educational session and 1 month post educational session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start17 Feb 2022
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EsteemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- University students will be recruited to participate in 1 educational session on the Injeti Self Esteem Model.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveen Injeti, OTD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258968
- Sponsor's protocol ID
- 5210395
- Status last verified
- Oct 2022
- First submitted
- 17 Feb 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information shared would relate to de-identified data analyzed for publication with our fellow researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Injeti Self-Esteem Model (ISEM) for Improving Self-esteem Among University
- ClinicalTrials.gov ID
- NCT05258968
- Acronym / sponsor ID
- 5210395
- Conditions
- Self Esteem
- Keywords
- Self Esteem, Relationships, University students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- University students will be recruited to participate in 1 educational session on the Injeti Self Esteem Model.
| Arm | Type | Receives |
|---|---|---|
| Educational Session on the Injeti Self Esteem Model | Experimental | Other: Education on the Injeti Model of Self-EsteemThe participant will participate in a 1 hour educational session on the Injeti Self Esteem model. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- <18 or >35 years of age
- Does not meet student status
- Not fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on the Injeti Model of Self-Esteem1 hour educational session | Other | Educational Session on the Injeti Self Esteem Model |
Primary outcome
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).
Level of knowledge assessment
Time frame: Change between 1 week Post educational session and 1 month post educational session.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Yes. Information shared would relate to de-identified data analyzed for publication with our fellow researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Injeti, OTD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on the Injeti Model of Self-Esteem in people with Self Esteem, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Esteem (time frame: Change between baseline and 2 weeks post educational session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.