NCT07368556

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress7%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

January 20, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

January 20, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

self harmadolescentpsychiatric nursingrandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    six weeks

Study Arms (2)

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.

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.

Behavioral: Group receiving routine treatment and follow-up at the polyclinic.

Interventions

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.

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,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 Nursing Care Program based on Human Caring Theory

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya City Hospital

Antalya, 07080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Dudu KARAKAYA, PhD

    Akdeniz University

    STUDY DIRECTOR
  • Hilal KARA, MSN

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
For the randomization process, individuals were randomly assigned to groups using stratified block randomization (www.randomizer.org). For the random assignment process, individuals were randomly assigned to groups using stratified block randomization (www.randomizer.org). This ensured one-way blinding, preventing adolescents with self-harming behavior from knowing whether they were in the intervention or control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: It is a randomized controlled, single-blind experimental study. There is an experimental and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 26, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations