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.

ConditionsAttention Deficit Disorder Attention Deficit Disorder (ADD)Attention Deficit Disorder with Hyperactivity ADHD ADD ADHD-not Other Specified ADHD or ADHD Traits ADHD Predominantly Hyperactivity Type ADHD Predominantly Inattentive Type ADHD with Sleep Onset Insomnia ADHD, ADD ADHD, Predominantly Hyperactive - Impulsive ADHD, Predominantly Inattentive Type Hyperactivity Hyperactivity Disorder Inattention

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-17

SponsorSt. Antonius Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous use of stimulants

1st or 2nd degree family member using stimulants for ADHD/ADD within the last two years

Trial design

Design model

Parallel

Treatments tested in this trial

Communication Strategy for Side Effect Counseling in ADHD Treatment
Other intervention
One group receives negatively framed and extensive information about the most common adverse events of methylphenidate. A fixed script will be prepared for the treating paediatrician, and the same information will be provided in written form. The other group receives positively framed and concise information about the most common adverse events of methylphenidate. This information will also be provided in written form.

Treatment groups

130 Participants

are divided into 2 treatment groups

Group A: Positively framed and concise information of adverse eventsExperimental treatment 1 intervention

Group B: Negatively framed and comprehensive information of adverse eventsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Adverse events

The primary outcome measure is the percentage of children suffering from decreased appetite in the first 4 weeks of using methylphenidate. All adverse events and their severity will be assessed using the Pittsburgh Side-Effects Rating Scale (PSRS).

Time frame