Self EsteemNCT04296812
Self-Esteem: A Protective Mechanism for Adolescent Mental Health
A study testing Self-Love Model in people with Self Esteem and Suicide and Self-harm, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Self Esteem, Suicide and Self-harm
- What is being tested?
- Self-Love Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Behavioral Medicine Center
Loma Linda, California, 92373
About this study
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.
Read the 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.
- Conditions
- Self Esteem, Suicide and Self-harm
- Being tested
- Self-Love Model
- Keywords
- occupational Therapy, self-esteem intervention, cognitive behavioral therapy, psychoeducation, suicide
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Love ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-Love Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes between baseline and 40 days post initial screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start13 Mar 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EsteemStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Kugel, OTD, OTR/L, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296812
- Sponsor's protocol ID
- 5190499
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Esteem: A Protective Mechanism for Adolescent Mental Health
- ClinicalTrials.gov ID
- NCT04296812
- Acronym / sponsor ID
- 5190499
- Conditions
- Self Esteem, Suicide and Self-harm
- Keywords
- occupational Therapy, self-esteem intervention, cognitive behavioral therapy, psychoeducation, suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injeti Self-Love Model | Experimental | Behavioral: Self-Love ModelPsychoeducational 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Love ModelThe 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. | Behavioural | Injeti Self-Love Model |
Primary outcome
Improvement in Self-esteem
Time frame: Changes between baseline and 40 days post initial screening.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Kugel, OTD, OTR/L principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Love Model in people with Self Esteem and Suicide and Self-harm, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Self-esteem (time frame: Changes between baseline and 40 days post initial screening.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.