Not Yet RecruitingNot Applicable

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.

130 participantsStarted 2025-01-25

Plain-language summary

The goal of this randomized controlled care evaluation is to determine whether positively framed and concise information (PFI), compared to negatively framed and extensive information (NFI) about adverse events can reduce the number and severity of reported adverse events caused by ADHD medication in children aged 7 to 17 years. The main questions it aims to answer are: 1. Does PFI reduce the percentage of children suffering from decreased appetite in the first 4 weeks after starting medication compared to NFI? 2. Does PFI reduce the total number of adverse events compared to NFI? 3. Does PFI lower the total score on the Pittsburgh Side Effects Rating Scale (PSRS) compared to NFI? 4. Does PFI lead to higher parental satisfaction with the explanation of adverse events compared to NFI? 5. Does PFI reduce the number of patients who discontinue medication due to adverse events compared to NFI? 6. Does PFI decrease the number of patients needing melatonin for sleeping problems due to the use of methylphenidate compared to NFI? 7. What is the relationship between baseline factors such as age, ADHD or ADD diagnosis, and gender on the number of adverse events? Researchers will compare children who receive positively framed, concise information (PFI) to those who receive negatively framed, detailed information (NFI) to determine if the framing of information affects the prevalence and severity of reported side effects, medication adherence, and parental satisfaction. Participants in this study will: * Be randomly assigned to receive either PFI or NFI about the side effects of methylphenidate. * Start taking methylphenidate according to standard care protocols. * Complete a Pittsburgh Side Effects Rating Scale (PSRS) questionnaire 4 weeks after starting medication to report any adverse events and their severity. * Parents will provide feedback on satisfaction with the explanation of side effects using a short questionnaire. This trial aims to inform best practices for communicating potential side effects to improve medication adherence and the overall treatment experience for children with ADHD and their families.

Who can participate

Age range

7 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events

Timeframe: From enrollment to 4 weeks after starting medication

Trial details

NCT IDNCT06797570

SponsorSt. Antonius Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-06

Contact for this trial

Arine Vlieger, Pediatrician

+31883206345 a.vlieger@antoniusziekenhuis.nl

View on ClinicalTrials.gov More Attention Deficit Disorder trials