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

Pelham 1989.

Study characteristics
Methods Cross‐over trial with 2 interventions:
  • MPH

  • placebo


Phases
  • No clear method description: "The procedure was double‐blind placebo‐controlled in which each child received, in random order with condition varied daily, placebo twice/d and 0.3 mg MPH/kg twice/d." ‐ "5 to 9 days of data were gathered"

Participants Number of participants screened: not stated
Number of participants included: 24 (12 boys, 12 girls)
Number followed up: not stated
Number of withdrawals: not stated
Diagnosis of ADHD: DSM‐III (combined (not stated), hyperactive‐impulsive (19/24), inattentive (2/24))
Age: mean not reported (range: boys 5 years 6 months‐11 years; girls 5 years 8 months‐11 years 3 months)
IQ: boys 100.8 (SD 14.23), girls 104.0 (SD 16.52)
MPH‐naive: not stated
Ethnicity: not stated
Country: USA
Setting: outpatient clinic (summer treatment programme)
Comorbidity: attention deficit disorder (1/24), CD (5/24), ODD (15/24), learning disability (6/25)
Comedication: yes; other doses of stimulants reported but not on trial days
Other sociodemographics: none
 
Inclusion criteria
  • None stated


Exclusion criteria
  • Children with an intellectual disability and those who had gross neurological disorders were not included in the trial

Interventions Participants were randomly assigned to 1 of 2 possible drug condition orders of 0.3 mg/kg methylphenidate and placebo. "Each child received, in random order with condition varied daily, placebo twice a day and 0.3 mg MPH/kg twice a day."
Mean MPH dosage: boys 9.8 mg (range 5.3‐16.9), girls 9.5 mg (range 5.2‐13.1)
Administration schedule: twice daily at breakfast and at lunchtime
Duration of each medication condition: not stated
Washout before trial initiation: not stated
Medication‐free period between interventions: no
Titration period: none
Treatment compliance: not stated
Outcomes ADHD symptoms
  • Abbreviated CTRS: 1‐3 times per condition

  • Revised Behaviour Problem Checklist: counsellor‐rated, 1‐3 times per condition

  • IOWA CTRS (IOWA CTRS)


General behaviour
  • Daily frequencies (following rules, non‐compliance, positive peer behaviours, conduct problems, negative verbalisations, numbers of time‐outs per day): daily

  • Time‐out: daily

  • Classroom measures, teacher recorded: daily

  • Daily report card

  • Observed peer interaction using modification of RECESS code: daily

Notes Sample calculation: no
Ethics approval: not stated
Comment from trial authors
  • Trial involved only 12 boys and 12 girls; 1 dose of MPH in the context of a highly structured summer programme: results must be considered preliminary


Key conclusions of trial authors
  • Results revealed equivalent and beneficial effects of MPH for both boys and girls

  • MPH therefore would appear to be a treatment that is as useful for girls with ADD as for boys with ADD


Comments from review authors
  • Data reported from this trial cannot be considered robust

  • No information on ethics committee approval, on randomisation, on primary endpoint (multiple endpoints), on sample size calculation, on safety, etc. Concomitant behavioural treatment was provided, but no details are given in the Methods section


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: not stated
Any withdrawals due to AEs: not stated
Funding source: not declared
Email correspondence with trial authors: October 2014. We received no supplemental information/data from trial authors. We asked authors whether this article was part of the Johnston 1988 trial but received no response, so we extracted the data as from 2 separate studies
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Each child received, in random order with condition varied daily, placebo and MPH
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes Low risk Active medication and placebo were disguised in gelatin capsules and were pre‐packaged in individual, dated envelopes
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not stated
Selection bias (e.g. titration after randomisation → exclusion): unclear
Selective reporting (reporting bias) Unclear risk No protocol found