FocusHELP-MIDNCT07582939
School Nurse-Led Help-Seeking Program in Middle School Students
A study testing School Nurse-Led Symptom Awareness and Help-Seeking Education Program in people with Focus and School Health, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of a school nurse-led symptom awareness and appropriate help-seeking program on the health behaviors of middle school students. In school settings, middle school students frequently experience common symptoms such as headache, abdominal pain, or fatigue but may have difficulty… Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus, School Health, Symptom Awareness
- What is being tested?
- School Nurse-Led Symptom Awareness and Help-Seeking Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to Jun 2026
- 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 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between 10 and 13 years of age (5th-7th grade students)
- Providing written informed consent from parents and assent from the student
- Regular school attendance
- No condition preventing participation in group sessions
Who cannot join
- Presence of a diagnosed neurological or psychiatric condition that may prevent participation in group activities
- Cognitive or developmental impairments that significantly affect communication
- Planned long-term school absence during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a School Nurse-Led Symptom Awareness and Appropriate Help-Seeking Program on Health Behaviors of Middle School Students: A Randomized Controlled Pilot Study
This study aims to evaluate the effect of a school nurse-led symptom awareness and appropriate help-seeking program on the health behaviors of middle school students. In school settings, middle school students frequently experience common symptoms such as headache, abdominal pain, or fatigue but may have difficulty recognizing their significance and seeking appropriate help. Improving symptom awareness and help-seeking behaviors in middle school students is essential for promoting health and preventing potential complications.
This cluster randomized controlled pilot study will be conducted among middle school students. Classes will be randomly assigned to either the intervention or control group. The intervention group will receive a structured, school nurse-led education program consisting of four sessions focusing on recognizing body signals, understanding common symptoms, and making appropriate help-seeking decisions. The control group will continue with routine school activities without receiving the intervention.
Data will be collected at baseline and after the intervention using a scenario-based help-seeking assessment and a help-seeking attitude form. The results of this study are expected to provide evidence for the effectiveness of school nurse-led interventions in improving students' health behaviors and contribute to the development of school health programs.
Read the detailed description
Middle school years represent a critical developmental period during which health behaviors and help-seeking patterns begin to take shape. Middle school students frequently experience common physical symptoms such as headache, abdominal pain, dizziness, and fatigue; however, they may have difficulty recognizing these symptoms as meaningful body signals and deciding when and from whom to seek help. Inadequate symptom awareness and inappropriate help-seeking behaviors in this age group may lead to delayed care, increased health risks, and ineffective use of school health services. Therefore, school-based interventions targeting symptom awareness and appropriate help-seeking behaviors are essential in school health nursing practice.
This study is designed as a cluster randomized controlled pilot trial to evaluate the effectiveness of a school nurse-led symptom awareness and appropriate help-seeking program on the health behaviors of middle school students (approximately aged 10-13 years). Randomization will be conducted at the class level to minimize contamination between students within the same school environment. Classes will be randomly assigned to either the intervention group or the control group.
The intervention group will receive a structured education program delivered by a school nurse over four sessions. The program focuses on recognizing body signals, understanding common symptoms, interpreting symptom severity, and making appropriate help-seeking decisions within the school context (e.g., seeking help from a teacher, school nurse, or family member). The content is designed to be age-appropriate, interactive, and supportive of students' active participation. The control group will continue with routine school activities without receiving any additional intervention.
Data will be collected at two time points: baseline (pre-test) and post-intervention (post-test). The primary outcome is help-seeking behavior, assessed using a scenario-based help-seeking test. Secondary outcomes include help-seeking attitudes and school health office visit records. The scenario-based assessment evaluates students' ability to recognize symptom severity and choose appropriate help-seeking strategies in common school-related situations.
The findings of this study are expected to provide preliminary evidence regarding the effectiveness and feasibility of school nurse-led interventions in improving symptom awareness and help-seeking behaviors among middle school students. The results will contribute to the development of evidence-based school health programs and support the role of school nurses in promoting early recognition of health problems and appropriate use of health services.
- Conditions
- Focus, School Health, Symptom Awareness, Help-Seeking Behavior
- Being tested
- School Nurse-Led Symptom Awareness and Help-Seeking Education Program
- Keywords
- Middle School Students, School Nursing, Help-Seeking Behavior, Symptom Awareness, Health Education, Cluster Randomized Controlled Trial, Adolescent Health Behavior
- Medical subject headings
- Help-Seeking Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School Nurse-Led Symptom Awareness and Help-Seeking Education ProgramBehavioural
This intervention is a structured, school nurse-led education program designed to improve symptom awareness and appropriate help-seeking behaviors among middle school students. The program consists of four sessions delivered in a classroom setting. The content includes recognizing body signals, identifying common symptoms such as headache, abdominal pain, dizziness, and fatigue, interpreting symptom severity, and making appropriate help-seeking decisions within the school environment (e.g., seeking help from a teacher, school nurse, or family member).
The sessions are designed to be age-appropriate, interactive, and student-centered, incorporating discussions and real-life scenarios to enhance understanding and engagement. The program aims to support students in developing the ability to recognize when a symptom requires attention and to choose appropriate sources of help.
| Study group | Role | What they receive |
|---|---|---|
| School Nurse-Led Education Program | Experimental | Students in this group will receive a school nurse-led symptom awareness and appropriate help-seeking education program consisting of four structured sessions. The program focuses on recognizing body signals, understanding common symptoms, interpreting symptom severity, and making appropriate help-seeking decisions within the school setting. Receives: Behavioral: School Nurse-Led Symptom Awareness and Help-Seeking Education Program |
| Routine School Activities | No intervention | Students in this group will continue with routine school activities and will not receive any additional intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Help-Seeking Behavior Score (Scenario-Based Assessment)
The primary outcome is students' help-seeking behavior, assessed using a scenario-based help-seeking test developed for middle school students. The assessment evaluates students' ability to recognize symptom severity and select appropriate help-seeking actions in common school-related situations (e.g., seeking help from a teacher, school nurse, or family member). Scores range from 0 to 10, with higher scores indicating more appropriate help-seeking behavior.
Measured: Baseline and 4 weeks (post-intervention)
Secondary outcomes (1)
School Health Office Visits
The number of visits to the school health office will be recorded to provide supportive data on students' health-related behaviors during the study period.
Measured: During the 4-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start15 Apr 2026
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FocusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized parallel-group design with class-level allocation.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TUĞÇE KOLUKISA, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582939
- Sponsor's protocol ID
- KBU-HEM464-503441
- Acronym
- HELP-MID
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a School Nurse-Led Symptom Awareness and Appropriate Help-Seeking Program on Health Behaviors of Middle School Students: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07582939
- Acronym / sponsor ID
- HELP-MID / KBU-HEM464-503441
- Conditions
- Focus, School Health, Symptom Awareness, Help-Seeking Behavior
- Keywords
- Middle School Students, School Nursing, Help-Seeking Behavior, Symptom Awareness, Health Education, Cluster Randomized Controlled Trial, Adolescent Health Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 May 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.
This study aims to evaluate the effect of a school nurse-led symptom awareness and appropriate help-seeking program on the health behaviors of middle school students. In school settings, middle school students frequently experience common symptoms such as headache, abdominal pain, or fatigue but may have difficulty recognizing their significance and seeking appropriate help. Improving symptom awareness and help-seeking behaviors in middle school students is essential for promoting health and preventing potential complications.
This cluster randomized controlled pilot study will be conducted among middle school students. Classes will be randomly assigned to either the intervention or control group. The intervention group will receive a structured, school nurse-led education program consisting of four sessions focusing on recognizing body signals, understanding common symptoms, and making appropriate help-seeking decisions. The control group will continue with routine school activities without receiving the intervention.
Data will be collected at baseline and after the intervention using a scenario-based help-seeking assessment and a help-seeking attitude form. The results of this study are expected to provide evidence for the effectiveness of school nurse-led interventions in improving students' health behaviors and contribute to the development of school health programs.
Detailed description
Middle school years represent a critical developmental period during which health behaviors and help-seeking patterns begin to take shape. Middle school students frequently experience common physical symptoms such as headache, abdominal pain, dizziness, and fatigue; however, they may have difficulty recognizing these symptoms as meaningful body signals and deciding when and from whom to seek help. Inadequate symptom awareness and inappropriate help-seeking behaviors in this age group may lead to delayed care, increased health risks, and ineffective use of school health services. Therefore, school-based interventions targeting symptom awareness and appropriate help-seeking behaviors are essential in school health nursing practice.
This study is designed as a cluster randomized controlled pilot trial to evaluate the effectiveness of a school nurse-led symptom awareness and appropriate help-seeking program on the health behaviors of middle school students (approximately aged 10-13 years). Randomization will be conducted at the class level to minimize contamination between students within the same school environment. Classes will be randomly assigned to either the intervention group or the control group.
The intervention group will receive a structured education program delivered by a school nurse over four sessions. The program focuses on recognizing body signals, understanding common symptoms, interpreting symptom severity, and making appropriate help-seeking decisions within the school context (e.g., seeking help from a teacher, school nurse, or family member). The content is designed to be age-appropriate, interactive, and supportive of students' active participation. The control group will continue with routine school activities without receiving any additional intervention.
Data will be collected at two time points: baseline (pre-test) and post-intervention (post-test). The primary outcome is help-seeking behavior, assessed using a scenario-based help-seeking test. Secondary outcomes include help-seeking attitudes and school health office visit records. The scenario-based assessment evaluates students' ability to recognize symptom severity and choose appropriate help-seeking strategies in common school-related situations.
The findings of this study are expected to provide preliminary evidence regarding the effectiveness and feasibility of school nurse-led interventions in improving symptom awareness and help-seeking behaviors among middle school students. The results will contribute to the development of evidence-based school health programs and support the role of school nurses in promoting early recognition of health problems and appropriate use of health services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized parallel-group design with class-level allocation.
| Arm | Type | Receives |
|---|---|---|
| School Nurse-Led Education Program | Experimental | Behavioral: School Nurse-Led Symptom Awareness and Help-Seeking Education ProgramStudents in this group will receive a school nurse-led symptom awareness and appropriate help-seeking education program consisting of four structured sessions. The program focuses on recognizing body signals, understanding common symptoms, interpreting symptom severity, and making appropriate help-seeking decisions within the school setting. |
| Routine School Activities | No intervention | –Students in this group will continue with routine school activities and will not receive any additional intervention during the study period. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being between 10 and 13 years of age (5th-7th grade students)
- Providing written informed consent from parents and assent from the student
- Regular school attendance
- No condition preventing participation in group sessions
Key exclusion criteria (3 listed)
- Presence of a diagnosed neurological or psychiatric condition that may prevent participation in group activities
- Cognitive or developmental impairments that significantly affect communication
- Planned long-term school absence during the study period
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 |
|---|---|---|
| School Nurse-Led Symptom Awareness and Help-Seeking Education ProgramThis intervention is a structured, school nurse-led education program designed to improve symptom awareness and appropriate help-seeking behaviors among middle school students. The program consists of four sessions delivered in a classroom setting. The content includes recognizing body signals, identifying common symptoms such as headache, abdominal pain, dizziness, and fatigue, interpreting symptom severity, and making appropriate help-seeking decisions within the school environment (e.g., seeking help from a teacher, school nurse, or family member). The sessions are designed to be age-appropriate, interactive, and student-centered, incorporating discussions and real-life scenarios to enhance understanding and engagement. The program aims to support students in developing the ability to recognize when a symptom requires attention and to choose appropriate sources of help. | Behavioural | School Nurse-Led Education Program |
Primary outcome
Help-Seeking Behavior Score (Scenario-Based Assessment)
Time frame: Baseline and 4 weeks (post-intervention)
The primary outcome is students' help-seeking behavior, assessed using a scenario-based help-seeking test developed for middle school students. The assessment evaluates students' ability to recognize symptom severity and select appropriate help-seeking actions in common school-related situations (e.g., seeking help from a teacher, school nurse, or family member). Scores range from 0 to 10, with higher scores indicating more appropriate help-seeking behavior.
1 secondary outcome
School Health Office Visits
Time frame: During the 4-week intervention period
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 13 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School Nurse-Led Symptom Awareness and Help-Seeking Education Program in people with Focus and School Health, run by Karabuk 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 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: under way, not looking for participants, as of the sponsor's last update on 13 May 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?
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?
Help-Seeking Behavior Score (Scenario-Based Assessment) (time frame: Baseline and 4 weeks (post-intervention)). 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 13 May 2026.