Bukstein 1998.
Study characteristics | ||
Methods | Cross‐over trial with 3 interventions:
Phases: trial included 2 phases: a baseline phase and the medication trial itself. The baseline phase occurred during the first 2 weeks (9 days) of the programme, when the children were medication‐free. Each medication condition was administered for 7 days of the programme during the 21‐day trial |
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Participants | Number of participants screened: not stated Number of participants included: 18 Number of participants followed up: 18 (14 boys, 4 girls) Number of withdrawals: 0 DSM‐III‐R criteria for ADHD and ODD or CD Age: mean 9.4 years (range 6.1‐12.2) IQ: not stated MPH‐naive: not stated Ethnicity: white (17%), African American (83%) Country: USA Setting: outpatient clinic (summer school at clinic) Comorbidity: ODD (56%) and CD (44%) Comedication: no Other sociodemographics: participants were predominantly from lower socioeconomic classes, with an average Hollingshead Index of Social Status of 3.83 (SD 1.65, range 1 to 5). 13 (72%) of the participants' families were receiving public assistance. Only 4 of the children lived with both biological parents; 12 (67%) lived with their biological mother only. Inner city environment characterised by higher than average rates of poverty and community violence. No significant differences in baseline demographics between groups Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 6 possible drug condition orders of MPH (0.3 mg/kg or 0.6 mg/kg) and placebo Mean MPH dosage: not stated Administration schedule: 8:30 am, 11:45 AM and 3:00 pm Duration of each medication condition: 7 days Washout before trial initiation: 9 days Medication‐free period between interventions: none Titration period: none Treatment compliance: poor compliance with the weekend medication condition; most families missed ≥ 1 dose each weekend of the trial. Poor compliance with the 3‐dose regimen was so widespread that trial authors omitted from the trial all data on weekend doses |
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Outcomes |
ADHD symptoms
Non‐serious AE
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Notes |
Key conclusions of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: no Funding source: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Schedule for each condition was randomly assigned across the 5 weekdays to minimise programme effects; the only qualifying condition was that approximately half of the 7 days of each medication condition would occur during each half of the 21‐day trial |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Nurse and other Summer Treatment and Enrichment Program (STEP) staff, children and parents were blinded to dosages and schedules |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Each child's daily data were collected and entered by trained research associates, who were unaware of medication status |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All included in the analyses Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no. Number of non‐responders and responders was calculated but not used to exclude participants |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |