Viewing Study NCT04296812



Ignite Creation Date: 2024-05-06 @ 2:22 PM
Last Modification Date: 2024-10-26 @ 1:29 PM
Study NCT ID: NCT04296812
Status: COMPLETED
Last Update Posted: 2022-09-28
First Post: 2020-03-03

Brief Title: Self-Esteem A Protective Mechanism for Adolescent Mental Health
Sponsor: Loma Linda University
Organization: Loma Linda University

Study Overview

Official Title: Self-Esteem A Protective Mechanism for Adolescent Mental Health
Status: COMPLETED
Status Verified Date: 2022-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None