Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04296812 |
Other study ID # |
5190499 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 13, 2020 |
Est. completion date |
September 30, 2020 |
Study information
Verified date |
September 2022 |
Source |
Loma Linda University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.