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Open Access Study protocol

Central nervous system stimulants for secondary attention deficit-hyperactivity disorder after paediatric traumatic brain injury: a rationale and protocol for single patient (n-of-1) multiple cross-over trials

Hugh EJ Senior1*, Lynne McKinlay2, Jane Nikles1, Philip J Schluter34, Sue-Ann Carmont1, Mary-Clare Waugh5, Adrienne Epps6, Owen Lloyd2 and Geoffrey K Mitchell1

Author Affiliations

1 Discipline of General Practice, School of Medicine, The University of Queensland, 11 Salisbury Rd, Ipswich 4305, Australia

2 Queensland Children’s Medical Research Institute, Level 4, Foundation Building, Royal Children's Hospital, Herston, Queensland 4029, Australia

3 School of Health Sciences, University of Canterbury, 20 Kirkwood Ave, Ilam 8041, New Zealand

4 School of Nursing and Midwifery, The University of Queensland, Queensland 4305, Australia

5 Rehabilitation Department, The Children's Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, Sydney, NSW, 2145, Australia

6 Rehabilitation Department, Sydney Children's Hospital, High St, Randwick, NSW 2031, Australia

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BMC Pediatrics 2013, 13:89  doi:10.1186/1471-2431-13-89

Published: 28 May 2013

Abstract

Background

It is estimated that 22,800 children were living with an Acquired Brain Injury (ABI) (0.6% of children aged under 15 years) in Australia during 2003. Many children after a traumatic brain injury will experience difficulties with attention and concentration; a condition termed secondary Attention Deficit-Hyperactivity Disorder. There is conflicting evidence on whether treatment with stimulant therapy with medications such as methylphenidate or dexamphetamine will improve the attention and behavior of children with this condition.

Methods/Design

Single patient trials (n-of-1s or SPTs) evaluate the effect of titrated doses of psychostimulants methylphenidate or dexamphetamine compared to placebo on attention and behavior, in children with TBI and secondary ADHD. The aggregation of multiple SPTs will produce a population estimate of the benefit. Forty-two children will be registered into the trial through rehabilitation services at three large children’s hospitals in Australia. Patients will complete up to 3 cycles of treatment. Each cycle is 2 weeks long comprising seven days each of treatment and placebo, with the first two days of each cycle considered a washout period and the data not analysed. The order of treatment and placebo is randomly allocated for each cycle. The Conners’ Parent Rating Scales long forms will be employed to measure change in attention-deficit/hyperactivity and related problems of the child, and the primary outcome measure is the Conners’ Global Index Parent Version. Secondary outcomes include the teacher and child (if aged > 12 years) Conners’ Rating Scales, the Behaviour Rating Inventory of Executive Function among other measures. This study will provide high-level evidence using a novel methodological approach to inform clinicians about the most appropriate treatment for individual children. Through aggregation of individual trials, a population estimate of treatment effect will be provided to guide clinical practice in the treatment of children with secondary ADHD after a traumatic brain injury.

Discussion

This study employs an innovative methodological approach on the effectiveness of CNS stimulants for secondary ADHD from a brain injury. The findings will both guide clinicians on treatment recommendations, and inform the concept and acceptance of SPTs in paediatric research.

Trial registration

Australian New Zealand Clinical Trials Registry. ACTRN12609000873224

Keywords:
Traumatic brain injury; TBI; Children; Methylphenidate hydrochloride; MPH; Dexamphetamine; n-of-1 trial