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Search / Trial NCT06797570

The Primary Objective of This Study is to Determine Whether Positively Framed Information (PFI) on Side Effects, Compared to Negatively Framed and Extensive Information (NFI) Can Reduce the Number and Severity of Reported Adverse Events Caused by ADHD Medication in Children Aged 7 to 17 Years.

Launched by ST. ANTONIUS HOSPITAL · Jan 22, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder Hyperactivity Inattention Adverse Drug Reaction Adverse Events Side Effects Nocebo Effect Medication Side Effects Patient Education Communication Methods Communication Strategies Pediatric Care Parental Satisfaction Pharmacological Treatment Treatment Medication Adherence Medication Child Health Side Effect Management Treatment Compliance Pediatric Pharmacology Positive Framing Negative Framing Side Effect Reporting

ClinConnect Summary

This clinical trial is exploring how different ways of sharing information about side effects may affect children taking medication for ADHD. Specifically, researchers want to see if giving positive and straightforward information (called Positively Framed Information or PFI) can help reduce side effects and improve satisfaction compared to providing detailed and negative information (Negatively Framed Information or NFI). The study will involve children aged 7 to 17 who have recently been diagnosed with ADHD and want to start medication.

Participants will be randomly assigned to receive either PFI or NFI about the side effects of the medication they will be taking. After four weeks, they will fill out a questionnaire to report any side effects they experienced and how severe they were. Parents will also provide feedback about how satisfied they were with the information given about these side effects. The goal is to find better ways to communicate potential side effects to help children stick with their treatment and improve their overall experience.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children aged 7 to 17 years
  • Recently diagnosed with ADHD or ADD by a psychologist
  • Desire to start ADHD/ADD medication expressed by both the child and the parents
  • Exclusion Criteria:
  • Previous use of stimulants
  • 1st or 2nd degree family member using stimulants for ADHD/ADD within the last two years

About St. Antonius Hospital

St. Antonius Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong emphasis on collaboration, the hospital brings together a multidisciplinary team of experts to conduct high-quality research across various therapeutic areas. Committed to ethical standards and patient safety, St. Antonius Hospital aims to contribute to the development of new treatments and therapies that enhance the quality of care for its diverse patient population. Through its robust clinical trial program, the hospital seeks to translate scientific discoveries into tangible health benefits.

Locations

Patients applied

0 patients applied

Trial Officials

Arine Vlieger, MD, PhD

Principal Investigator

St. Antonius Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported