Methods |
Design: three group parallel trial
Purpose: study the effect of methylphenidate and multimodal psychological treatment on children with attention‐deficit/hyperactivity disorder |
Participants |
Patients: children with attention‐deficit/hyperactivity disorder
Baseline comparability: yes (except for socioeconomic status) |
Interventions |
Placebo: sessions with attention control interventions with no social skills training
Untreated: no sessions
Experimental: sessions with social skills training
(Co‐intervention: All patients received methylphenidate) |
Outcomes |
Social skills rating scale (parents)
Social skills rating scale (children)
Taxonomy of problem situations (teachers)
Direct school observations
Parental practices
Academic achievements
Emotional status |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
NS |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (attention control placebo/multimodal psychological intervention) |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient (parents) 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 = 69 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |