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.

Sponsor
St. Antonius Hospital
Study ID
NCT06797570
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Communication Strategy for Side Effect Counseling in ADHD Treatment — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jan 28, 2025
Start date
Jan 25, 2025
Status verified
Jan 2025
Primary completion
Jan 6, 2027
Completion
Jan 6, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Positively framed and concise information of adverse events
    PFI: A positively framed and concise discussion of adverse events (e.g. "Most children continue to feel fine with this medication, and if adverse events do occur, they often resolve quickly after the first few days of adjustment. If symptoms do appear, wait a little to see if they subside. If they persist and you are concerned, you can always check the package insert to see if it is listed as adverse event. You can also contact the clinic at any time."). A fixed script will be prepared for the treating paediatrician, and similar information will be provided in written form for parents and children.
  • Experimental: Negatively framed and comprehensive information of adverse events
    NFI: A comprehensive, negatively framed, discussion of the most common adverse events: difficulty falling asleep, decreased appetite, nausea, other gastrointestinal complaints, headache, sadness, or flat affect (e.g. "many patients experience nausea in the first month") as well as the more serious events like dullness of tics. A fixed script (see addendum) will be prepared for the treating paediatrician, and similar information will be provided to parents and their child in written form.

Primary Outcome Measure

Adverse events [ Time Frame: From enrollment to 4 weeks after starting medication ]

Central Contacts

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