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

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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