| Methods |
Design: three group, multi‐period cross‐over trial (number of periods NS)
Purpose: examine the perception of what influenced mood and behaviour (causal attribution) in boys treated for attention deficit hyperactivity disorder by methylphenidate or placebo |
| Participants |
Patients: boys with attention deficit hyperactivity disorder attending a summer camp
Baseline comparability: not relevant |
| Interventions |
Placebo: tablet with no methylphenidate
Untreated: no tablet
Experimental: tablet with methylphenidate
(Co‐intervention:
‐summer camp treatment program (behavioural therapy principles)
‐same boys also participated in trials with other drugs on days not included in the present study) |
| Outcomes |
Behaviour rating scales, including ratings of "Did you have a good day?"
Attribution rating scales (what the children themselves thought influenced behaviour or mood)
Mood/self‐esteem rating scales
Forced‐Choice Questions |
| Notes |
The outcome data was not available from the first period only, and was calculated as deriving from a parallel group trial. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'... designed to examine ADHD boys' causal attributions in a double‐blind, within‐subject, placebo‐controlled medication trial' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 76 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |