APPENDICES. A systematic review and economic model of the ...

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316 Appendix 12 Study Intervention Participants Outcomes Core symptoms Classroom measures: on-task behaviour Individual target measures (Daily Report Cards) IOWA Conners’ Rating Scale: inattention–overactivity (counsellors, teachers, parents) Inclusion criteria 1. Diagnosis of ADHD 2. No medical history prohibiting psychostimulant medication or participation in STP activities. Arm 1 MPH plus non-drug intervention 0.3 mg/kg/dose administered a.m., noon and p.m. Monday to Thursday; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Reference Pelham et al., 1999 81 Source NICE Report Diagnostic criteria DSM-IV Setting USA (STP) Co-existent problems Point system measures: following activity rules, non-compliance, interrupting, complaining, positive peer behaviours, conduct problems and negative verbalisations Classroom measures: rule-following behaviour and disruptive behaviour IOWA Conners’ Rating Scale: oppositional/defiant (counsellors, teachers, parents) Number Total randomised = 21 (male = 19) No withdrawals reported Arm 2 MPH plus non-drug intervention 0.3 mg/kg/dose administered in the morning and placebo at noon and p.m. Monday to Thursday; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Design Crossover trial Randomisation procedure: Each participant was randomised daily to one of seven drug conditions Duration Treatment period: 6 weeks Age 10.26 years (mean); 6–12 years (range) Educational performance Classroom measures: accuracy and productivity of seatwork tasks IQ 109.9 (mean) Co-morbid disorders Learning problems: n = 9/21; ODD: n = 14/21; CD: n = 5/21 Arm 3 MPH plus non-drug intervention 0.3 mg/kg/dose administered a.m. and noon and 0.15 mg/kg/dose administered in the afternoon Monday to Thursday; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Psychological function Not reported Depression or anxiety Not reported Diagnostic subtypes Not reported Quality of life Not reported Adverse events Pittsburgh Side Effect Rating Scale (counsellors, teachers, parents) Additional information Previous medication: 88% of participants were on MPH, 6% were on d-amphetamine and 6% were on clonidine before the STP Arm 4 Adderall plus non-drug intervention 0.3 mg/kg/dose administered a.m. and p.m. and placebo at noon, administered Monday to Thursday; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Purpose 1. To compare standard twice-daily PH dosing with a single morning dose of MPH and of Adderall during a typical school-day period 2. To conduct a dose–response study of the effects of a late-afternoon dose of MPH and Adderall on evening behaviour and side-effects Additional outcomes Not reported Arm 5 Adderall plus non-drug intervention 0.3 mg/kg/dose administered in the morning and placebo at noon and p.m., administered Monday to Thursday; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Arm 6 Adderall plus non-drug intervention continued
Study Intervention Participants Outcomes 0.3 mg/kg/dose in the morning, placebo at noon and 0.15 mg/kg/dose in the afternoon Administered Monday to Thursday; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) Arm 7 Placebo plus non-drug intervention Administered am, noon and pm Monday to Thursday; comprehensive behavioural programme incorporating parental training and a BM system (Individual administering medication not reported) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 317
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Appendices A systematic review and
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