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

Whalen 1990.

Study characteristics
Methods 2‐day cross‐over trial with 2 interventions
  • MPH 0.3 mg/kg

  • Placeb


In a connected trial 25 children were randomised to the same interventions. The outcome of this trial included the social judgement processes during the different drug conditions. Outcomes from the trial included in this review were reported in this connected trial.
Participants Number of participants screened: unknown
Number of participants included: 24
Number of participants followed up: 24 (22 boys, 2 girls)
Number of withdrawals: 0
ADHD diagnosis: trial 1 DSM‐III‐R
Age: trial one mean 9 years 8 months (range 6.4‐13.2 years)
IQ: no mental disability
MPH‐naive: 0%
Ethnicity: white (92%), African American (4%), Hispanic (4%)
Country: USA
Setting: outpatient clinic (Summer Treatment Program)
Comorbidity: not stated
Comedication: not stated
Other sociodemographics: all were from middle‐ or low middle‐income backgrounds
Inclusion criteria
  • Primary diagnosis of ADDH

  • Taking MPH on a regular basis before the programme

  • Conners' ADHD Stigma Questionnaire: ratings from parents > 15


Exclusion criteria
  • No information

Interventions Participants were randomly assigned to 1 of the possible drug condition orders of 0.3 mg/kg MPH or placebo.
Mean MPH dosage: 8.75 mg
Administration schedule: twice/d, morning and lunchtime
Duration of each medication condition: 1 day
Washout before trial initiation: unknown
Medication‐free period between interventions: medication and placebo were given on 2 consecutive days
Titration period: none
Treatment compliance: good (2 staff dispensed the medication for ingestion)
Outcomes General behaviour
  • Evaluations of Social Behaviors in Medicated and Unmedicated Peers (Negative detections): rated by healthy controls (children)

Notes Sample calculation: no
Ethics approval: no information
Key conclusions of trial authors
  • In both studies, double‐blind ratings done by naive and staff observers demonstrated nearly identical medication effects, that is, placebo‐related increases in behaviour problems and MPH‐related increases in dysphoria

  • Ratings of medication effects proved remarkably resilient, showing an invulnerability to biasing influences introduced by general knowledge about research design, diagnostic status or treatment effects; or by specific knowledge about and experience with participating children


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes; only participants taking maintenance dosage of MPH or well titrated
Any withdrawals due to AEs: no
Funding source: not stated
Email correspondence with trial authors: January 2014. No supplemental information has been received
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias)
All outcomes Low risk Both active medication and placebo were placed in opaque gelatin capsules. 2 staff, blinded to medication status, dispensed medication
Blinding of outcome assessment (detection bias)
All outcomes Low risk Assessments were made by independent healthy controls through video tapes
Incomplete outcome data (attrition bias)
All outcomes Low risk No dropouts
Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias) Low risk No indication of selective reporting