NCT04296812

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

March 3, 2020

Last Update Submit

September 26, 2022

Conditions

Keywords

occupational Therapyself-esteem interventioncognitive behavioral therapypsychoeducationsuicide

Outcome Measures

Primary Outcomes (1)

  • 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.

    Changes between baseline and 40 days post initial screening.

Study Arms (1)

Injeti Self-Love Model

EXPERIMENTAL

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.

Behavioral: Self-Love Model

Interventions

Self-Love ModelBEHAVIORAL

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.

Injeti Self-Love Model

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Behavioral Medicine Center

Loma Linda, California, 92373, United States

Location

MeSH Terms

Conditions

SuicideSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Julie Kugel, OTD, OTR/L

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

March 13, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations