Prospective observational study protocol to investigate long-term adverse effects of methylphenidate in children and adolescents with ADHD: the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study

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Abstract

Introduction

Methylphenidate is the most frequently used medication for the treatment of attention-deficit/hyperactivity disorder (ADHD) in Europe. Following concerns about its safety, the European Commission called for research into the long-term effects of methylphenidate on children and adolescents with ADHD. The Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) research programme was designed to address this call. At the heart of this programme is a 2-year longitudinal naturalistic pharmacovigilance study being conducted in 27 European sites.

Methods and analysis

3 cohorts of children and adolescents (aged 6–17) living in the UK, Germany, Italy and Hungary are being recruited:

Group 1 (Medicated ADHD): 800 ADHD medication-naive children and adolescents with a clinical diagnosis of ADHD about to start methylphenidate treatment for the first time.

Group 2 (Unmedicated ADHD): 400 children and adolescents with a clinical diagnosis of ADHD who have never been treated with ADHD medication and have no intention of beginning medication.

Group 3 (Non-ADHD): 400 children and adolescents without ADHD who are siblings of individuals in either group 1 or 2.

All participants will be assessed 5 times during their 2-year follow-up period for growth and development, psychiatric, neurological and cardiovascular health. The primary outcome measure will be the height velocity SD score.

Ethics and dissemination

Ethical approval for the study has been granted by the East of Scotland Research Ethics Service. Following this approval, patient information leaflets and consent forms were translated as necessary and submissions made by lead sites in each of the other 3 countries to their own ethics committees. Following ethical approval in each country, local ethical permissions at each site were sought and obtained as needed. The study's website ( http://www.adhd-adduce.org/page/view/2/Home) provides information for researchers, participants and the general public.

Trial registration number

NCT01470261.

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Most cited references 30

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The Development and Well-Being Assessment: description and initial validation of an integrated assessment of child and adolescent psychopathology.

H. Meltzer, Suzanne H Richards, Jason R Goodman … (2000)

The Development and Well-Being Assessment (DAWBA) is a novel package of questionnaires, interviews, and rating techniques designed to generate ICD-10 and DSM-IV psychiatric diagnoses on 5-16-year-olds. Nonclinical interviewers administer a structured interview to parents about psychiatric symptoms and resultant impact. When definite symptoms are identified by the structured questions, interviewers use open-ended questions and supplementary prompts to get parents to describe the problems in their own words. These descriptions are transcribed verbatim by the interviewers but are not rated by them. A similar interview is administered to 11-16-year-olds. Teachers complete a brief questionnaire covering the main conduct, emotional, and hyperactivity symptoms and any resultant impairment. The different sorts of information are brought together by a computer program that also predicts likely diagnoses. These computer-generated summary sheets and diagnoses form a convenient starting point for experienced clinical raters, who decide whether to accept or overturn the computer diagnosis (or lack of diagnosis) in the light of their review of all the data, including transcripts. In the present study, the DAWBA was administered to community (N = 491) and clinic (N = 39) samples. There was excellent discrimination between community and clinic samples in rates of diagnosed disorder. Within the community sample, subjects with and without diagnosed disorders differed markedly in external characteristics and prognosis. In the clinic sample, there was substantial agreement between DAWBA and case note diagnoses, though the DAWBA diagnosed more comorbid disorders. The use of screening questions and skip rules greatly reduced interview length by allowing many sections to be omitted with very little loss of positive information. Overall, the DAWBA successfully combined the cheapness and simplicity of respondent-based measures with the clinical persuasiveness of investigator-based diagnoses. The DAWBA has considerable potential as an epidemiological measure, and may prove to be of clinical value too.

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Psychometric properties of the revised Developmental Coordination Disorder Questionnaire.

Alice Aylott, Seán G. Roberts, Bonnie Kaplan … (2008)

The Developmental Coordination Disorder Questionnaire (DCDQ) is a parent-completed measure designed to identify subtle motor problems in children of 8 to 14.6 years of age. The purpose of this study was to extend the lower age range to children aged 5 to 7 years, revise items to ensure clarity, develop new scoring, and evaluate validity of the revised questionnaire. Additional items with improved wording were generated by an expert panel. Analyses of internal consistency, factor loading, and qualitative/quantitative feedback from researchers, clinicians, and parents were used to select 15 items with the strongest psychometric properties. Internal consistency was high (alpha = .94). The expanded questionnaire was completed by the parents of 287 children, aged 5-15 years, who were typically developing. Logistic regression modeling was used to generate separate cutoff scores for three age groups (overall sensitivity = 85%, specificity = 71%). The revised DCDQ was then compared to other standardized measures in a sample of 232 children referred for therapy services. Differences in scores between children with and without DCD (p < .001) provide evidence of construct validity. Correlations between DCDQ scores and Movement Assessment Battery for Children (r = .55) and Test of Visual-Motor Integration (r = .42) scores support concurrent validity. The results provide evidence that the revised DCDQ is a valid clinical screening tool for DCD.

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Standards from birth to maturity for height, weight, height velocity, and weight velocity: British children, 1965. II.

J M Tanner, R H Whitehouse, M Takaishi (1966)

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2016

Publication date (Electronic): 26 April 2016

Volume: 6

Issue: 4

Electronic Location Identifier: e010433

Affiliations

[1 ]Division of Neuroscience, School of Medicine, University of Dundee & Tayside Clinical Trials Unit, University of Dundee , Dundee, UK

[2 ]Child and Adolescent Neuropsychiatry Unit, Department of Biomedical Science, University of Cagliari , Cagliari, Italy

[3 ]Vadaskert Child and Adolescent Psychiatric Hospital , Budapest, Hungary

[4 ]Department of Child & Adolescent Psychiatry and Psychotherapy, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg , Mannheim, Germany

[5 ]Cognition and Behavior, Department of Cognitive Neuroscience, Radboud University Medical Centre, Donders Institute for Brain, Karakter Child and Adolescent Psychiatry University Centre , Nijmegen, The Netherlands

[6 ]Univercity Paris-Sud, Univ. Paris-Descartes, AP-HP, INSERM U1178 , Paris, France

[7 ]Faculty of Medicine & Health Sciences, Institute of Mental Health, University of Nottingham , Nottingham, UK

[8 ]Academic Unit of Psychology, University of Southampton , Southampton, UK

[9 ]School of Pharmacy, University College Cork , Cork, Ireland

[10 ]Department of Paediatrics and Adolescents Medicine, University Hospital Erlangen , Erlangen, Germany

[11 ]Evelina Children's Hospital, St Thomas’ Hospital , London, UK

[12 ]UK and Department of Experimental Clinical & Health Psychology, University of Southampton, Ghent University , Belgium

[13 ]UCL School of Pharmacy, 29-39 Brunswick Square , London, UK

[14 ]Division of Neuroscience, School of Medicine, University of Dundee , Dundee, UK

Author notes

[Correspondence to ] SK Inglis; s.k.inglis@ 123456dundee.ac.uk

Article

Publisher ID: bmjopen-2015-010433

DOI: 10.1136/bmjopen-2015-010433

PMC ID: 4853973

PubMed ID: 27118284

SO-VID: e9f3898d-2019-4340-9704-bf3f16efec7f

Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 2 November 2015

Date revision received : 29 January 2016

Date accepted : 18 March 2016

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Prospective observational study protocol to investigate long-term adverse effects of methylphenidate in children and adolescents with ADHD: the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

Negative Pressure Wound Therapy

Most cited references 30

The Development and Well-Being Assessment: description and initial validation of an integrated assessment of child and adolescent psychopathology.

Psychometric properties of the revised Developmental Coordination Disorder Questionnaire.

Standards from birth to maturity for height, weight, height velocity, and weight velocity: British children, 1965. II.

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Journal

Affiliations

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Article

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Cited by 11

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