- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582939
School Nurse-Led Help-Seeking Program in Middle School Students (HELP-MID)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Karabük, Turkey (Türkiye)
- Karabuk University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: School Nurse-Led Education Program
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.
|
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. |
|
No Intervention: Routine School Activities
Students in this group will continue with routine school activities and will not receive any additional intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline and 4 weeks (post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School Health Office Visits
Time Frame: During the 4-week intervention period
|
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.
|
During the 4-week intervention period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KBU-HEM464-503441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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