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

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Appendix 12
Study Intervention Participants Outcomes
Core symptoms
CPRS: impulsivity/hyperactivity
ACTeRS: hyperactivity, attention
Reference
Stein et al., 1996 91
Co-existent problems
CPRS: conduct problem
ACTeRS: social skills, oppositional
behaviour
Child Conflict Index (research
assistants): specific conflict
behaviours, negativity, social
withdrawal
Inclusion criteria
1. Scores >65 on the impulsivity/hyperactivity factor of the CPRS
2. Scores >65 on the attention factor of the CBCL
3. Ratings below 20th percentile for attention or hyperactivity problems
on the ACTeRS
4. No history of significant developmental delay
5. No diagnosis of pervasive developmental disorder
6. Willingness of parents and school personnel to meet study
requirements
Arm 1
MPH
2 × MPH capsules, 1 × lactose capsule
daily; 4 hours apart (8 a.m., 12 p.m.,
4 p.m.); mean dose 8.8 ± 0.5 mg/dose
(0.30 ± 0.1 mg/kg/dose), range
5–20 mg
(Administered by parent)
Source
AHRQ Report
Setting
USA
Design
Crossover trial
Diagnostic criteria
DSM-III
Educational performance
CPRS: learning problem
Number
Total randomised = 25 (male = 25)
Total withdrawals = 1
Arm 2
MPH
3 × MPH capsules daily; 4 hours apart
(8 a.m., 12 p.m., 4 p.m.); mean dose
same as above
(Administered by parent)
Psychological function
Test of Variables of Attention:
omission errors, commission errors,
response time, variability
Duration
Study period: 5 weeks;
baseline assessment
period: 1 week;
treatment period:
4 weeks (1 week per
treatment arm)
Depression or anxiety
CPRS: anxiety
Child Depression Inventory
Reasons for withdrawals:
Withdrawal from trial due to increased anxiety and negative mood
symptoms together with obsessive–compulsive behaviours. The authors
suggest that in retrospect, he appears to have had a primary anxiety
disorder
Age
8.0 years (mean); 6–12 years (range); 1.8 years (SD)
Arm 3
MPH
1 × MPH capsule with half test dose
and 2 × lactose capsules on first day;
4 hours apart (8 a.m., 12 p.m.,
4 p.m.); increased dosage until target
dose reached on day 6
(Administered by parent)
Quality of life
Not reported
Purpose
To evaluate the shortterm
efficacy and sideeffects
associated with
two MPH dosing
patterns
IQ
Not reported
Adverse events
SSERS (parents)
Additional outcomes
Sleep log (parents): time child sent to
bed, time child fell asleep, total sleep
duration
Actigraph measurements: activity
level, latency to sleep onset, duration
of sleep, number and duration of
awakenings
Weight
Heart rate
Blood pressure
Co-morbid disorders
ODD: n = 7/25; CD: n = 2/25.
Arm 4
Placebo
3 × lactose capsules daily; 4 hours
apart (8 a.m., 12 p.m., 4 p.m.)
(Administered by parent)
Diagnostic subtypes
ADHD–Combined Type: n = 22/25; ADHD–Predominantly Inattentive
Type: n = 3/25
Additional information
Previous medication:
14/25 (56%) had previously received MPH treatment.
There was a 5-day washout period before the beginning of the study
Co-interventions:
No additional psychoactive medications, including oral asthma or allergy
medications, were administered during the study