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.

NCT06797570 | Not Yet Recruiting

• 1 other identifier: R&D/Z24.090
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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:

• 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.

Conditions

Attention 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; Hyperactivity; Hyperactivity Disorder; Inattention

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

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to 4 weeks after starting medication

Secondary Outcomes (5)

• The total number of adverse events

  From enrollment to 4 weeks after starting medication

• PSRS score

  From enrollment to 4 weeks after starting medication

• Parental satisfaction

  From enrollment to 4 weeks after starting medication

• Patients who discontinued mediation

  From enrollment to 4 weeks after starting medication

• Melatonine users

  From enrollment to 4 weeks after starting medication

Study Arms (2)

Positively framed and concise information of adverse events

EXPERIMENTAL

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.

Other: Communication Strategy for Side Effect Counseling in ADHD Treatment

Negatively framed and comprehensive information of adverse events

EXPERIMENTAL

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.

Other: Communication Strategy for Side Effect Counseling in ADHD Treatment

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.

Negatively framed and comprehensive information of adverse events; Positively framed and concise information of adverse events

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Previous use of stimulants
• st or 2nd degree family member using stimulants for ADHD/ADD within the last two years

Sponsors & Collaborators

• St. Antonius Hospital: lead

Related Links

• 1\. Colloca L, Barsky AJ. Placebo and nocebo effects. N Engl J Med \[Internet\]. 2020 \[cited 2024 Sept 19\];382(6):554-61.
• 2\. Kamimura-Nishimura KI, Brinkman WB, Froehlich TE. Strategies for improving ADHD medication adherence. Curr Psychiatry \[Internet\]. 2019 \[cited 2024 Sept 19\];18(8):25-38.
• Webster RK, Weinman J, Rubin GJ. Positively framed risk information in patient information leaflets reduces side effect reporting: A double-blind randomized controlled trial. Ann Behav Med \[Internet\]. 2018 \[cited 2024 Sept 19\];52(11):920-9.
• Polanczyk G, De Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry \[Internet\]. 2007 \[cited 2024 Sept 20\];164(6):942-8. Available from: https://pubmed.ncbi.nlm.ni
• Van Der Schans J, Çiçek R, Vardar S, Bos J, De Vries TW, Hoekstra PJ. Methylphenidate use and school performance among primary school children: a descriptive study. BMC Psychiatry \[Internet\]. 2017 \[cited 2024 Sept 20\];17. Available from: https://pubme
• Cortese S, Adamo N, Del Giovane C, Mohr-Jensen C, Hayes AJ, Carucci S, et al. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta
• Elliott J, Johnston A, Husereau D, Kelly SE, Eagles C, Charach A, et al. Pharmacologic treatment of attention deficit hyperactivity disorder in adults: A systematic review and network meta-analysis. PLoS One \[Internet\]. 2020 \[cited 2024 Sept 20\];15(1
• NICE. Attention deficit hyperactivity disorder (update). \[C\] Evidence reviews for pharmacological efficacy and sequencing pharmacological treatment. NICE guideline \[Internet\]. September 2017 \[cited 2024 Sep 20\]; Available from: https://www.nice.org.u
• Nanda A, Janga LSN, Sambe HG, Yasir M, Man RK, Gogikar A, et al. Adverse effects of stimulant interventions for attention deficit hyperactivity disorder (ADHD): A comprehensive systematic review. Cureus \[Internet\]. 2023 \[cited 2024 Sept 20\];15(9):e45
• Kamal M, Eltohami M, Al-Shibli S. Effect and side effect of stimulant/methylphenidate on children and adolescents with ADHD: the Qatar experience. Arch Pediatr \[Internet\]. 2018 \[cited 2024 Sept 20\];3:160. Available from: https://www.gavinpublishers.c
• Graham J, Coghill D. Adverse effects of pharmacotherapies for attention-deficit hyperactivity disorder: epidemiology, prevention and management. CNS Drugs \[Internet\]. 2008 \[cited 2024 Sept 20\];22(3):213-37. Available from: https://pubmed.ncbi.nlm.nih
• Hodgkins P, Sasané R, Christensen L, Harley C, Liu F. Treatment outcomes with methylphenidate formulations among patients with ADHD: retrospective claims analy-sis of a managed care population. Curr Med Res Opin \[Internet\]. 2011 \[cited 2024 Sept 20\];
• World Health Organization. Adherence to long-term therapies: Evidence for action. Genève, Switzerland: World Health Organization \[Internet\]. 2003 \[cited 2024 Sept 20\]. Available from: https://iris.who.int/handle/10665/42682
• Whitford HS, Olver IN. When expectations predict experience: the influence of psychological factors on chemotherapy toxicities J. J Pain Symptom Manage \[Internet\]. 2012 \[cited 2024 Sept 23\];43(6):1036-50. Available from: https://pubmed.ncbi.nlm.nih.g
• Prediger B, Meyer E, Büchter R, Mathes T. Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial. Trials \[Internet\]. 2019 \[cited 2024 Sept 23\];20(
• De Bruijn C, Hamming G, Knibbe C, Tromp E, Benninga MA. Vlieger AM. Teenagers' and parental individual needs for side effects information and the influence of nocebo effect education. Patient Educ Couns \[Internet\]. 2023 \[cited 2024 Sept 23\];108(10758
• Mohammadi MR, Mostafavi SA, Keshavarz SA, Eshraghian MR, Hosseinzadeh P, Hosseinzadeh-Attar MJ, et al. Melatonin effects in methylphenidate treated children with attention deficit hyperactivity disorder: a randomized double blind clinical trial. Iran
• Lee J, Grizenko N, Bhat V, Sengupta S, Polotskaia A, Joober R. Relation between therapeutic response and side effects induced by methylphenidate as observed by parents and teachers of children with ADHD. BMC Psychiatry \[Internet\]. 2011 \[cited 2024 Se
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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm; Drug-Related Side Effects and Adverse Reactions; Medication Adherence; Patient Compliance

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Arine Vlieger, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arine Vlieger, Pediatrician

CONTACT

+31883206345; a.vlieger@antoniusziekenhuis.nl

Carin Bunkers, research nurse

CONTACT

+31883209748; k.bunkers@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student investigator medicine

Model Details: This study is a parallel-group randomized controlled care evaluation. This parallel design compares two already existing communication strategies regarding counseling on ADHD medication and adverse events in a clinical setting simultaneously. Random assignment to one of the two communication methods controls for potential biases and ensures that ob-served differences are attributable to the specific communication approach. A 4-week follow-up period is selected to provide adequate time for the medication's adverse events to become apparent and for meaningful data collection on adverse events and patient satisfaction. The study is planned to last a maximum period of 24 months. The anticipated start date is January 1st, 2025, with a projected end date no later than January 1st, 2027. Given that the pediatric department of the St. Antonius hospital sees more than 300 new ADHD patients an-nually and we aim to include 130 participants, we expect to complete the study within this timeframe.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 28, 2025
• Study Start: January 25, 2025
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): January 6, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01