Self HarmNCT07368556
The Impact of a Nursing Care Program Based on Human Caring Theory on Adolescents With Self-harm
A study testing Group receiving Nursing Care Program based on Human Caring Theory and Group receiving routine treatment and follow-up at the polyclinic. in people with Self Harm, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of a Nursing Care Program based on Human Caring Theory on self-esteem, coping, and self-compassion in adolescents exhibiting self-harming behavior. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Self Harm
- What is being tested?
- Group receiving Nursing Care Program based on Human Caring Theory and Group receiving routine treatment and follow-up at the polyclinic.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study will include adolescents who:
- are aged 14-18 years,
- volunteer to participate in the study, and
- have self-harm according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
Who cannot join
- Adolescents with speech, hearing, comprehension, or visual impairments, as well as those receiving psychosocial support during the research process, will not be included in the study.
- Sampling Exclusion Criteria:
- Adolescents who did not participate in all interviews
- Were admitted to the Child and Adolescent Psychiatry clinic for treatment during the research process,
- Did not wish to continue participating in the interviews will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Antalya City Hospital
Antalya, 07080
Hilal KARA, MSN, +90 531 370 38 11, ucanhilal26@gmail.com
About this study
Official title: The Effect of a Nursing Care Program Based on Human Caring Theory on Self-Esteem, Coping, and Self-Compassion in Adolescents With Self-Harm
The aim of this study is to examine the effect of a Nursing Care Program based on Human Caring Theory on self-esteem, coping, and self-compassion in adolescents exhibiting self-harming behavior.
Hypotheses of the research:
Read more
H1-a: The self-esteem level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
H1-b: The self-compassion level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
H1-c: The coping level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
This study is a randomized, controlled, single-blind experimental design. It will be conducted between March 2026 and March 2027 at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital with 48 adolescents (24 in the intervention group and 24 in the control group) who meet the inclusion criteria. The Human Caring Theory-Based Nursing Care Program will be applied individually and face-to-face to adolescents in the intervention group through structured therapeutic interviews. Data will be collected using a Personal Information Form, the Inventory of Statements About Self-injury, the Rosenberg Self-Esteem Scale, the Coping Scale for Adolescents, and the Short Form of the Self-Compassion Scale. Data analysis will be performed using the Statistical Package for Social Science (SPSS) 31.0 software package. It is believed that the Human Caring Theory-Based Nursing Care Program may be effective in improving self-esteem, self-compassion, and coping skills in adolescents exhibiting self-harm behavior.
Read the detailed description
Self-harm is when an individual injures or harms themselves in order to cope with or express emotional distress and confusion. Examples of self-harm include attempting to poison oneself by overdosing on drugs or harmful substances, cutting and scratching the skin, self-burning, and punching oneself. Systematic reviews and meta-analyses of various countries, including Turkey, have found that self-harm behavior ranges from 16% to 17.7% and is particularly high among adolescents. Furthermore, systematic reviews and meta-analyses indicate that self-harm is more common in adolescent girls than in adolescent boys, and is higher in Asia. Umbrella reviews, systematic reviews, and meta-analyses show that many factors influence suicidal and self-harm. Self-esteem, self-compassion, and coping skills are some of the risk factors for self-harm.
Self-harm is a strong predictor of suicide attempts, is repetitive, and is one of the leading causes of death. Early intervention for self-harm can reduce the risk of suicide and death later in life. It is emphasized that planned interventions for self-harm should include alternative behavioral skills and problem-solving strategies, address the individual's strengths in collaboration, utilize individualized coping methods and self-care approaches, and be individualized, structured, and limited in duration. Human Caring Theory adopts the approach that each individual is unique and requires a holistic approach, that treatment is possible only with the individual's participation, and that the individual cannot be considered separately from their environment. Accordingly, it may be appropriate and effective for psychiatric nurses caring for adolescents exhibiting self-harm to base their care processes on Human Caring Theory. A review of the literature reveals that studies in nursing with adolescents based on Human Caring Theory are limited, and additionally, no experimental studies with individuals exhibiting self-harm behavior have been found. It is thought that a nursing care program based on the Human Caring Theory can contribute to the development of coping skills, self-compassion, and self-esteem in adolescents exhibiting self-harm, and can also reduce this behavior. The study suggests that this approach may be effective in protecting adolescents with self-harm from the risk of suicidal behavior and life-threatening risks associated with self-harm, and in maintaining their healthy development.
- Conditions
- Self Harm
- Being tested
- Group receiving Nursing Care Program based on Human Caring Theory, Group receiving routine treatment and follow-up at the polyclinic.
- Keywords
- self harm, adolescent, psychiatric nursing, randomized controlled trial
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group receiving Nursing Care Program based on Human Caring TheoryBehavioural
Adolescents who can be included in the study are determined by interviewing the group of physicians working at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital. Providing verbal information about the research to adolescents and parents/guardians, obtaining written consent from adolescents and parents/guardians who agree to participate in the research, administering the measurement tools,implementing the Human Caring Theory-Based Nursing Care Program for a total of six weeks, once a week, re-administering the measurement tools, conducting a follow-up measurement after six weeks,terminating the interview.
Group receiving routine treatment and follow-up at the polyclinic.Behavioural
Adolescents who can be included in the study are determined by interviewing the group of physicians working at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital. Providing verbal information about the research to adolescents and parents/guardians, obtaining written consent from adolescents and parents/guardians who agree to participate in the research, administering the measurement tools, application of measurement tools after six weeks, follow-up measurement after six weeks, terminating the interview.
| Study group | Role | What they receive |
|---|---|---|
| Group receiving Nursing Care Program based on Human Caring Theory | Experimental | In addition to routine treatment and follow-up at the Child and Adolescent Mental Health and Diseases Outpatient Clinic, the Human Caring Theory-Based Nursing Care Program will be implemented face-to-face and individually through therapeutic interviews. Receives: Behavioral: Group receiving Nursing Care Program based on Human Caring Theory |
| Group receiving routine treatment and follow-up at the polyclinic. | Active comparator | The control group will receive only routine treatment and follow-up at the Child and Adolescent Mental Health and Diseases Outpatient Clinic. Receives: Behavioral: Group receiving routine treatment and follow-up at the polyclinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosenberg Self Esteem Scale (RSE)
1st, 2nd, and 3rd questions; 4th and 5th questions; and 9th and 10th questions are evaluated together.
If a respondent receives points on any two of the first three questions (2 out of 3), they receive one point from this set.
If they select one of the options that receives a point in either the 4th or 5th question, they also receive one point from this set.
The 9th and 10th questions are evaluated in the same way as the 4th and 5th questions.
The 6th, 7th, and 8th questions are each scored individually. Thus, when a respondent receives points from all question sets, the maximum possible total score is 6.
Measured: six weeks
The Short Form of Self-Compassion Questionnaire
The Short Form of the Self-Compassion Scale can be administered to middle school and high school students.
Items 1, 4, 8, 9, 10, and 11 on the scale are reverse-coded. As the total score obtained from the scale increases, the level of self-compassion also increases.
During the adaptation of the scale into Turkish, one item was removed.
Measured: six weeks
Coping Scale for Adolescents (CSA)
The scale consists of 11 items. Items 3, 6, 8, and 10 are related to active coping. Items 1, 2, 9, and 11 are related to avoidance coping. Items 4, 5, and 7 are related to negative coping.
Each subscale score is obtained by summing the scores of the relevant items. The possible score range is 0-12 for active coping and avoidance coping, and 0-9 for negative coping. Higher scores on the scale indicate more frequent use of the corresponding coping approach.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start18 Mar 2026
- Primary completion4 Oct 2026
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self HarmStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized controlled, single-blind experimental study. There is an experimental and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Kara, Akdeniz University
- Investigators
- Dudu KARAKAYA, PhD, Study director, Akdeniz UniversityHilal KARA, MSN, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368556
- Sponsor's protocol ID
- AU-SBE-HK-01
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nursing Care Program Based on Human Caring Theory on Self-Esteem, Coping, and Self-Compassion in Adolescents With Self-Harm
- ClinicalTrials.gov ID
- NCT07368556
- Acronym / sponsor ID
- AU-SBE-HK-01
- Conditions
- Self Harm
- Keywords
- self harm, adolescent, psychiatric nursing, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 4 Oct 2026 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Jan 2026 (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.
The aim of this study is to examine the effect of a Nursing Care Program based on Human Caring Theory on self-esteem, coping, and self-compassion in adolescents exhibiting self-harming behavior.
Hypotheses of the research:
H1-a: The self-esteem level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
H1-b: The self-compassion level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
H1-c: The coping level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
This study is a randomized, controlled, single-blind experimental design. It will be conducted between March 2026 and March 2027 at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital with 48 adolescents (24 in the intervention group and 24 in the control group) who meet the inclusion criteria. The Human Caring Theory-Based Nursing Care Program will be applied individually and face-to-face to adolescents in the intervention group through structured therapeutic interviews. Data will be collected using a Personal Information Form, the Inventory of Statements About Self-injury, the Rosenberg Self-Esteem Scale, the Coping Scale for Adolescents, and the Short Form of the Self-Compassion Scale. Data analysis will be performed using the Statistical Package for Social Science (SPSS) 31.0 software package. It is believed that the Human Caring Theory-Based Nursing Care Program may be effective in improving self-esteem, self-compassion, and coping skills in adolescents exhibiting self-harm behavior.
Detailed description
Self-harm is when an individual injures or harms themselves in order to cope with or express emotional distress and confusion. Examples of self-harm include attempting to poison oneself by overdosing on drugs or harmful substances, cutting and scratching the skin, self-burning, and punching oneself. Systematic reviews and meta-analyses of various countries, including Turkey, have found that self-harm behavior ranges from 16% to 17.7% and is particularly high among adolescents. Furthermore, systematic reviews and meta-analyses indicate that self-harm is more common in adolescent girls than in adolescent boys, and is higher in Asia. Umbrella reviews, systematic reviews, and meta-analyses show that many factors influence suicidal and self-harm. Self-esteem, self-compassion, and coping skills are some of the risk factors for self-harm.
Self-harm is a strong predictor of suicide attempts, is repetitive, and is one of the leading causes of death. Early intervention for self-harm can reduce the risk of suicide and death later in life. It is emphasized that planned interventions for self-harm should include alternative behavioral skills and problem-solving strategies, address the individual's strengths in collaboration, utilize individualized coping methods and self-care approaches, and be individualized, structured, and limited in duration. Human Caring Theory adopts the approach that each individual is unique and requires a holistic approach, that treatment is possible only with the individual's participation, and that the individual cannot be considered separately from their environment. Accordingly, it may be appropriate and effective for psychiatric nurses caring for adolescents exhibiting self-harm to base their care processes on Human Caring Theory. A review of the literature reveals that studies in nursing with adolescents based on Human Caring Theory are limited, and additionally, no experimental studies with individuals exhibiting self-harm behavior have been found. It is thought that a nursing care program based on the Human Caring Theory can contribute to the development of coping skills, self-compassion, and self-esteem in adolescents exhibiting self-harm, and can also reduce this behavior. The study suggests that this approach may be effective in protecting adolescents with self-harm from the risk of suicidal behavior and life-threatening risks associated with self-harm, and in maintaining their healthy development.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is a randomized controlled, single-blind experimental study. There is an experimental and control group
| Arm | Type | Receives |
|---|---|---|
| Group receiving Nursing Care Program based on Human Caring Theory | Experimental | Behavioral: Group receiving Nursing Care Program based on Human Caring TheoryIn addition to routine treatment and follow-up at the Child and Adolescent Mental Health and Diseases Outpatient Clinic, the Human Caring Theory-Based Nursing Care Program will be implemented face-to-face and individually through therapeutic interviews. |
| Group receiving routine treatment and follow-up at the polyclinic. | Active comparator | Behavioral: Group receiving routine treatment and follow-up at the polyclinic.The control group will receive only routine treatment and follow-up at the Child and Adolescent Mental Health and Diseases Outpatient Clinic. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- are aged 14-18 years,
- volunteer to participate in the study, and
- have self-harm according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
Key exclusion criteria (5 listed)
- Adolescents with speech, hearing, comprehension, or visual impairments, as well as those receiving psychosocial support during the research process, will not be included in the study.
- Adolescents who did not participate in all interviews
- Were admitted to the Child and Adolescent Psychiatry clinic for treatment during the research process,
- Did not wish to continue participating in the interviews will be excluded from the study.
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 |
|---|---|---|
| Group receiving Nursing Care Program based on Human Caring TheoryAdolescents who can be included in the study are determined by interviewing the group of physicians working at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital. Providing verbal information about the research to adolescents and parents/guardians, obtaining written consent from adolescents and parents/guardians who agree to participate in the research, administering the measurement tools,implementing the Human Caring Theory-Based Nursing Care Program for a total of six weeks, once a week, re-administering the measurement tools, conducting a follow-up measurement after six weeks,terminating the interview. | Behavioural | Group receiving Nursing Care Program based on Human Caring Theory |
| Group receiving routine treatment and follow-up at the polyclinic.Adolescents who can be included in the study are determined by interviewing the group of physicians working at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital. Providing verbal information about the research to adolescents and parents/guardians, obtaining written consent from adolescents and parents/guardians who agree to participate in the research, administering the measurement tools, application of measurement tools after six weeks, follow-up measurement after six weeks, terminating the interview. | Behavioural | Group receiving routine treatment and follow-up at the polyclinic. |
Primary outcome
Rosenberg Self Esteem Scale (RSE)
Time frame: six weeks
1st, 2nd, and 3rd questions; 4th and 5th questions; and 9th and 10th questions are evaluated together. If a respondent receives points on any two of the first three questions (2 out of 3), they receive one point from this set. If they select one of the options that receives a point in either the 4th or 5th question, they also receive one point from this set. The 9th and 10th questions are evaluated in the same way as the 4th and 5th questions. The 6th, 7th, and 8th questions are each scored individually. Thus, when a respondent receives points from all question sets, the maximum possible total score is 6.
The Short Form of Self-Compassion Questionnaire
Time frame: six weeks
The Short Form of the Self-Compassion Scale can be administered to middle school and high school students. Items 1, 4, 8, 9, 10, and 11 on the scale are reverse-coded. As the total score obtained from the scale increases, the level of self-compassion also increases. During the adaptation of the scale into Turkish, one item was removed.
Coping Scale for Adolescents (CSA)
Time frame: six weeks
The scale consists of 11 items. Items 3, 6, 8, and 10 are related to active coping. Items 1, 2, 9, and 11 are related to avoidance coping. Items 4, 5, and 7 are related to negative coping. Each subscale score is obtained by summing the scores of the relevant items. The possible score range is 0-12 for active coping and avoidance coping, and 0-9 for negative coping. Higher scores on the scale indicate more frequent use of the corresponding coping approach.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
Dudu KARAKAYA, PhD study director
Akdeniz University
Hilal KARA, MSN principal investigator
Akdeniz 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 Group receiving Nursing Care Program based on Human Caring Theory and Group receiving routine treatment and follow-up at the polyclinic. in people with Self Harm, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilal KARA, MSN (+90 531 370 38 11, ucanhilal26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rosenberg Self Esteem Scale (RSE) (time frame: six weeks). The study lists 3 primary outcomes in all. 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 27 Oct 2026.