- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04296812
Self-Esteem: A Protective Mechanism for Adolescent Mental Health
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Loma Linda, California, United States, 92373
- Loma Linda University Behavioral Medicine Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Injeti Self-Love Model
Psychoeducational intervention focusing improving self-esteem and increasing self-awareness.
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The model is a visual illustration shaped as a triangle.
The strategies being discussed:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Self-esteem
Time Frame: Changes between baseline and 40 days post initial screening.
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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.
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Changes between baseline and 40 days post initial screening.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie Kugel, OTD, OTR/L, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5190499
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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