Kolko 1999.
Study characteristics | ||
Methods | Randomised, placebo‐controlled, cross‐over trial with 2 possible drug interventions and placebo, as well as 2 possible psychological interventions:
and
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Participants | Number of participants screened: 70 Number of participants included: 22 (all boys) Number of participants followed up: 16 Number of withdrawals: 6 Diagnosis of ADHD: DSM‐III‐R (subtypes not stated) Age: mean 9.6 years (range 6.9‐12.9) IQ: not stated MPH‐naive: not stated Ethnicity: African American (75%) Country: USA Setting: "partial hospitalisation" summer treatment programme Comorbidity: CD (44%), ODD (56%), anxiety disorder (18.8%), major depressive disorder (11.5%), dysthymia (6%), intermittent explosive disorder (6%), developmental articulation disorder (6%), asthma (12.5%) Comedication: not stated Other sociodemographics: 3 lived with 1 or both parents, 6 lived with grandparents, 1 lived with an aunt, 4 lived with non‐relatives, 2 lived with foster mother. 44% of families received welfare Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to different possible drug condition orders of 0.3 mg/kg and 0.6 mg/kg MPH and placebo Mean MPH dosage: not stated Administration schedule: 8:00 am and 11:30 am to 12.00 pm Duration of each medication condition: 1 day. Each medication condition was administered once per week for a total of 6 days during the trial Washout before trial initiation: 2 weeks Medication‐free period between interventions: no Titration period: none Treatment compliance: not stated Behavioural intervention: behaviour modification and no behaviour modification were alternated on a weekly basis for a total of 3 weeks per condition |
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Outcomes |
ADHD symptoms
Non‐serious AEs
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Notes | Sample calculation: not stated Ethics approval: not stated Key conclusions of trial authors
Comments from review authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: yes, 2 Funding source: not declared Email correspondence with trial author: January 2014. We were unable to obtain additional data (Nilausen 2014 [pers comm]) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Each MPH condition was administered once per week for a total of 6 days during the trial, and behaviour modification and no behaviour modification were alternated on a weekly basis, for a total of 3 weeks per condition. Thus, daily MPH conditions were crossed with 2, weekly behavioural intervention conditions |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | It is stated: "MPH or placebo was placed in identical opaque capsules" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | High risk | Not stated Selection bias: exclusion of 2 participants with challenging behaviour |
Selective reporting (reporting bias) | Unclear risk | No protocol available |