NCT05258968

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

February 17, 2022

Last Update Submit

October 31, 2022

Conditions

Keywords

Self EsteemRelationshipsUniversity students

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

Study Arms (1)

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.

Other: Education on the Injeti Model of Self-Esteem

Interventions

1 hour educational session

Educational Session on the Injeti Self Esteem Model

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • \<18 or \>35 years of age
  • Does not meet student status
  • Not fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Study Officials

  • Praveen Injeti, OTD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: University students will be recruited to participate in 1 educational session on the Injeti Self Esteem Model.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 28, 2022

Study Start

February 17, 2022

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Information shared would relate to de-identified data analyzed for publication with our fellow researchers.

Shared Documents
SAP
Time Frame
After data collection.

Locations