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

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Appendix 12
Study Intervention Participants Outcomes
Core symptom
Abbreviated IOWA/Conners’ Rating Scale:
inattentive/overactive (evaluated in the
classroom and enrichment room)
Inclusion criteria
1. 7–13 years of age
2. No concurrent medication
Arm 1
MPH plus non-drug intervention
Low-dose MPH (0.3 mg/kg) and high
dose MPH (0.6 mg/kg). Each MPH
condition was administered twice
daily (8 and 11.30 a.m.) one day per
week for six weeks (a total of 6 days).
Behaviour modification (BM)
consisted of the STEP programme: a
5 days/week, 8 hours/day programme
consisting of hourly, structured
therapeutic, educational and
recreational activities (e.g. skills
group, classroom enrichment, gym).
BM was alternated with no behaviour
modification on a weekly basis for a
total of 3 weeks each
(Administered by medical personnel)
Reference
Kolko et al., 1999 69
Source
Updated search
Co-existent problems
Abbreviated IOWA/Conners’ Rating Scale:
oppositional/defiant
Overt Aggression Scale (verbal aggression,
physical aggression against objects, physical
aggression against people)
Peer conflicts
Positive mood/behaviour (social skills group,
gym and field)
Diagnostic criteria
DSM-III-R
Number
Total randomised = 22 (male = 22)
Total withdrawals = 6
Setting
USA
(Partial hospitalisation –
STP)
Reasons for withdrawals: 2 were hospitalised for aggressive and
unmanageable behaviour, 2 had serious side-effects in the first
week and 2 later declined to take MPH
Design
Crossover trial
Educational performance
Not reported
Randomisation procedure:
Note that each drug treatment was administered for 6 days over
the 6-week trial (randomly administered on a daily basis, each
once per week, across a 3-day period)
Psychological function
Not reported
Age
9.6 years (mean); 1.9 years (SD)
Depression or anxiety
Not reported
IQ
Not reported
Co-morbid disorders
CD: n = 7/16 (44%); ODD: n = 9/16 (56%); three children
also had an anxiety disorder, 2 had major depressive disorder, 1
had dysthymia and 1 had intermittent explosive disorder
Arm 2
MPH
Doses as above with no BM
(Administered by medical personnel)
Duration
6 weeks
Purpose
To evaluate the separate
and incremental effects
of two doses of MPH
and behaviour
modification in children
with ADHD and comorbid
disorders across
multiple settings
Quality of life
Not reported
Adverse events
Stimulant Drug Side Effects Rating Scale
Arm 3
Placebo plus non-drug intervention
Placebo with BM
(Administered by medical personnel)
Additional outcomes
Not reported
Diagnostic subtypes
Not reported
Additional information
Previous medication:
Before the trial began, there was a 2-week baseline during
which no MPH was given. All patients had failed to respond to
less intensive outpatient treatment
Arm 4
Placebo
Placebo only
(Administered by medical personnel)
Concurrent medication:
Individuals receiving other medication were excluded from the
trial