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Self-Esteem: A Protective Mechanism for Adolescent Mental Health

Primary Purpose

Self Esteem, Suicide and Self-harm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Love Model
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Self Esteem focused on measuring occupational Therapy, self-esteem intervention, cognitive behavioral therapy, psychoeducation, suicide

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The sample will consist of up to 70 male and female adolescents.
  • Participants must also be English speaking, and are able to read and write in English.
  • Ages 14 to 17 admitted to an in-patient psychiatric facility for:

    • suicidal ideation /attempts,
    • destruction to self or others,
    • homicidal ideation
    • Those that are unable to provide for his or her basic needs for food, clothing, or shelter because of a mental disorder.

Exclusion Criteria:

  • Presenting with unmanageable symptoms such as psychosis or mania
  • cognitive disabilities that prevent a participant from processing
  • Behavioral problems that can disrupt the session and or impair safety during the intervention.

Sites / Locations

  • Loma Linda University Behavioral Medicine Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Injeti Self-Love Model

Arm Description

Psychoeducational intervention focusing improving self-esteem and increasing self-awareness. The session will start with discussion on healthy relationships, self-esteem. A white board will be used in group format and regular 8.5" by 11" paper during individual session to illustrate the Self-Love model and the characteristics and traits that are effected by "self-love and "lack of self-love". At the end of illustration and discussion there will be handout of the "self-love intervention. The session will end by answering questions and emphasizing the importance of having self-awareness of traits that promote low-self-esteem, and finally, strategies to promote and maintain self-esteem.

Outcomes

Primary Outcome Measures

Improvement in Self-esteem
The Rosenberg Self-Esteem Scale is a 10-item self-report measure of global self-esteem. It contains 10 statements connected to global feelings of self-worth or self-acceptance. The items are answered on a four-point scale fluctuating from strongly agree to strongly disagree. A score between 15 and 25 is considered normal, while a score less than 15 indicates potential low self-esteem.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
September 26, 2022
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT04296812
Brief Title
Self-Esteem: A Protective Mechanism for Adolescent Mental Health
Official Title
Self-Esteem: A Protective Mechanism for Adolescent Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will explore the effects of the Injeti Self-Love Model intervention on adolescents challenged with low-self-esteem leading to self-harming, suicidal thoughts and suicidal attempts. This study will examine the promotion of self-esteem through the Injeti Self-Love Model as a safety measure against "poor behavioral habits" such as intentional self-harming, substance abuse, suicidal thinking and suicide attempt as means to cope. Study participation will include initial screening, self-assessment, occupational therapy self-esteem intervention of one session, with an individual follow-up, along with an interview, and finishing up with a one-month follow-up interview. The qualitative research is a methodology for investigating and considering the meaning individuals attribute to a significant human experience. The qualitative approach will be structured around a semi-structured interview initiated at the end of the second follow-up session and after 1-month follow-up.
Detailed Description
This study uses a mixed method quasi-experimental pretest and posttest design which incorporates characteristics of both qualitative and quantitative approaches The use of the mixed method design approach is to explore an intervention tool which is administered. The study will be conducted in a locked in-patient psychiatric facility on the adolescent unit. Participants will be engaging in two intervention sessions. The first session will be conducted individually or in a group format. The second session will consist of a follow-up individual session. Participation in this study involves the following: if the subjects meet the inclusion criteria; The research team will gather demographic data from the subjects medical chart which will include the following: gender, age, trauma history, family dynamics such as divorced, single parents, foster family, weight and height, residential and town or city of residence. Subject will be asked to complete a self-esteem assessment called the Rosenberg Self-Esteem Scale, this will take about 10 minutes. Then the subject will be invited to attend the occupational therapy self-esteem treatment session. The self-esteem intervention is already part of the curriculum at Loma Linda University Behavioral Medicine Center on the adolescent unit. If participants meet inclusion criteria and after signing of consents and PHI, and taking the self-assessment the subjects will be invited to join the self-esteem group session and or individual treatment session if they cannot make it to the group session. The self-esteem treatment is based on a psychoeducation process encouraging discussion and focus on self-awareness of ones own self-esteem. During group processing the therapist will provided the handout of the self-love model. Within 2 to 3 days of the self-esteem treatment session there will be an individual follow up session to review the intervention. A self-esteem improvement plan handout will be provided, the subject will complete the self-esteem assessment again and will participate in an interview that will be audio recorded. The interview will take approximately 15 minutes. Within 40 days of discharge the subjects will be contacted for a follow-up audio-recorded interview which may be conducted via phone, in-person or videoconference. The subject will also complete the self-esteem assessments again. This may take up to 30 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Esteem, Suicide and Self-harm
Keywords
occupational Therapy, self-esteem intervention, cognitive behavioral therapy, psychoeducation, suicide

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injeti Self-Love Model
Arm Type
Experimental
Arm Description
Psychoeducational intervention focusing improving self-esteem and increasing self-awareness. The session will start with discussion on healthy relationships, self-esteem. A white board will be used in group format and regular 8.5" by 11" paper during individual session to illustrate the Self-Love model and the characteristics and traits that are effected by "self-love and "lack of self-love". At the end of illustration and discussion there will be handout of the "self-love intervention. The session will end by answering questions and emphasizing the importance of having self-awareness of traits that promote low-self-esteem, and finally, strategies to promote and maintain self-esteem.
Intervention Type
Behavioral
Intervention Name(s)
Self-Love Model
Intervention Description
The model is a visual illustration shaped as a triangle. The bottom left line is title "Zero Self-Love", moving upward are characteristics identified from "zero self-love" along the line. The bottom right side is titled "Self-Love" moving upward are characteristics identified from having "self-love". At the top of the triangle is a circle with the letter "R" within for relationship. Two small lines project horizontally, from the circle, left and right. At the end of the Left line is a circle with the word "break-up" in the middle, surrounded by terms: drugs, alcohol, self-harming, suicide, and sex" as the consequence of "zero self-love". At the end of right line is a circle with the word "break-up" in the middle surrounded by terms: support system, coping skills, spirituality reflection as the consequences of having self-love. The strategies being discussed: Exploring self-esteem strategies. Importance of self-worth in relationships. Importance of self-awareness.
Primary Outcome Measure Information:
Title
Improvement in Self-esteem
Description
The Rosenberg Self-Esteem Scale is a 10-item self-report measure of global self-esteem. It contains 10 statements connected to global feelings of self-worth or self-acceptance. The items are answered on a four-point scale fluctuating from strongly agree to strongly disagree. A score between 15 and 25 is considered normal, while a score less than 15 indicates potential low self-esteem.
Time Frame
Changes between baseline and 40 days post initial screening.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The sample will consist of up to 70 male and female adolescents. Participants must also be English speaking, and are able to read and write in English. Ages 14 to 17 admitted to an in-patient psychiatric facility for: suicidal ideation /attempts, destruction to self or others, homicidal ideation Those that are unable to provide for his or her basic needs for food, clothing, or shelter because of a mental disorder. Exclusion Criteria: Presenting with unmanageable symptoms such as psychosis or mania cognitive disabilities that prevent a participant from processing Behavioral problems that can disrupt the session and or impair safety during the intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Kugel, OTD, OTR/L
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Behavioral Medicine Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92373
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-Esteem: A Protective Mechanism for Adolescent Mental Health

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