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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Bukstein 1998.

Study characteristics
Methods Cross‐over trial with 3 interventions:
  • MPH 0.3 mg MPH/kg

  • MPH 0.6 mg MPH/kg

  • placebo


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
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
  • DSM‐III criteria for ADHD and ODD or CD, while attending the Summer Treatment and Enrichment Program (STEP)


Exclusion criteria
  • Not stated

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
Outcomes ADHD symptoms
  • IOWA CRS: rated by staff daily

  • IOWA CPRS: rated by parents daily

  • CTRS: rated daily


Non‐serious AE
  • Side Effects Rating Scale: adaptation of the Barkley Side Effects Rating Scale, rated daily by staff and also rated by parents

Notes Key conclusions of trial authors
  • Staff ratings of behaviour of children in the programme and in an academic classroom showed that children displayed significant improvement in ADHD symptoms and aggressive behaviour with LD‐MPH and HD‐MPH conditions

  • At home, parents and guardians reported few significant differences in behaviour ratings between placebo and MPH

  • In both settings, MPH was well tolerated, with few side effects found during active drug conditions


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
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