Promoting Safe Medication Practices in the Classroom

NCT07389538 | Recruiting

• 1 other identifier: 4384/CEIH/2024
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Self-medication has traditionally been defined as the consumption of medicines, herbs, and home remedies on one's own initiative or on the advice of another person, without consulting a doctor. In Spain, the consumption of non-prescription drugs is quite widespread among young people, since more than half of them have used medications without a medical prescription in the last year. This high prevalence of self-medication among Spanish youth seems to be driven by various factors that encourage this practice. These include the increase in over-the-counter medications, delays in obtaining appointments at health centers, the influence of common family self-care practices, and the population's greater knowledge of and interest in health-related issues. Inappropriate use of medications constitutes a public health problem and can cause significant risks to users' health, such as adverse reactions, drug resistance, and complications in diagnosing diseases, since it can lead to the masking of symptoms, as well as an increase in morbidity. However, not all self-medication practices are harmful. Responsible self-medication refers to the use of over-the-counter medications (without a prescription) to treat common and mild symptoms (e.g., fever, mild pain, colds) for a reasonable period of time (two to three days, after which a doctor should be consulted if no improvement occurs). The benefits of responsible self-medication include convenience for the patient, reinforcement of personal autonomy through self-care, reduction of healthcare professionals' workload, and decreased costs to the healthcare system. In this regard, responsible self-medication not only provides individual and collective benefits but also promotes the development of personal autonomy, a key factor influencing young people's tendency to self-medicate. Attitudes toward autonomous medication use in young people are influenced by individual variables such as emotional regulation, family habits, peer influence, quality of life, and the use of other substances. Given that these factors-greater access to medications, delays in healthcare access, family self-care practices, and individual psychosocial characteristics-appear to drive self-medication behaviors among youth, it is hypothesized that an educational intervention developed with the support of artificial intelligence, and focused on the responsible and safe use of medications, will improve young people's knowledge and attitudes toward self-medication. By targeting both knowledge and attitudes, the intervention aims to strengthen responsible practices while fostering autonomy and informed decision-making in medication use.

Conditions

Self Medication

Keywords

Health Literacy; Adolescent; Quality of Life; Self Medication; Artificial Intelligence; Education

Outcome Measures

Primary Outcomes (1)

• Risk Self-Medication Questionnaire focused on Health Literacy (QAR-LS)

  The Risk Self-Medication Questionnaire focused on Health Literacy (QAR-LS) provides scores ranging from 35 to 175 points, where higher scores indicate a greater risk related to inadequate or unsafe self-medication practices.

  Data will be collected at baseline and again 6-9 months after the intervention.

Secondary Outcomes (2)

• Health-related quality of life (Kidscreen-27)

  Data will be collected at baseline and again 6-9 months after the intervention.

• Problem-focused coping styles (COPE-28)

  Data will be collected at baseline and again 6-9 months after the intervention.

Study Arms (2)

Control Group

NO INTERVENTION

The control group consisted of participants who were absent during the intervention but completed the post-intervention questionnaire.

Educational intervention

EXPERIMENTAL

Group receiving the structured educational program focused on the appropriate use of medications and the prevention of errors associated with self-medication.

Behavioral: Educational intervention

Interventions

Educational intervention BEHAVIORAL

The intervention will consist of a structured educational program focused on the appropriate use of medications and the prevention of errors associated with self-medication.

Educational intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Universidad de Granada: lead
• Ministerio de Ciencia, Innovación y Universidades: collaborator

Study Sites (1)

University of Granada

Granada, Granada, 18016, Spain

RECRUITING

Related Publications (5)

• Ramírez Puerta, D., Larrubia Muñoz, O., Escortell Mayor, E., & Martínez Martínez, R. (2006). La automedicación responsable, la publicidad farmacéutica y su marco en la Atención Primaria. SEMERGEN, Soc. Esp. Med. Rural Gen. (Ed. impr.), 117-124.

  BACKGROUND

• Morán, C., Landero, R., & González, M. T. (2010). COPE-28: un análisis psicométrico de la versión en español del Brief COPE. Universitas Psychologica, 9(2), 543-552.

  BACKGROUND

• Kidscreen Group (2004). Estudio europeo de salud y bienestar de niños/as y adolescentes. Cuestionario para chicos y chicas de 8 a 18 años. https://www.kidscreen.org/english/questionnaires/kidscreen-27/

  BACKGROUND

• Barreto, M. A. F., Negreiros, F. D. D. S., Cestari, V. R. F., Sampaio, H. A. C., & Moreira, T. M. M. (2024). Evidence of validity of the Risk Self-Medication Questionnaire focused on Health Literacy. Revista brasileira de enfermagem, 77(3), e20230386. https://doi.org/10.1590/0034-7167-2023-0386

  BACKGROUND

• Baracaldo-Santamaría, D., Trujillo-Moreno, M. J., Pérez-Acosta, A. M., Feliciano-Alfonso, J. E., Calderon-Ospina, C. A., & Soler, F. (2022). Definition of self-medication: a scoping review. Therapeutic advances in drug safety, 13, 20420986221127501. https://doi.org/10.1177/20420986221127501

  BACKGROUND

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• María Correa-Rodríguez, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Correa-Rodríguez, PhD

CONTACT

+34958243494; macoro@ugr.es

Blanca Rueda-Medina, PhD

CONTACT

+34958243494; blarume@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Longitudinal quasi-experimental clinical trial with a non-randomized control group in young people aged 15 to 24 years, designed to assess self-medication practices.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: March 17, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)