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

Firestone 1981.

Study characteristics
Methods 3‐month, randomised, double‐blind, placebo‐controlled, parallel trial, wherein participants were randomly assigned to 3 arms:
  • parent training + placebo (control group)

  • parent training + MPH (intervention group)

  • MPH

Participants Number of participants screened: 91
Number of participants included: not stated (includes boys and girls)
Number of participants followed up: intervention 18, control 13
Number of withdrawals: not stated
Diagnosis of ADHD: DSM‐III
Age: mean 7.32 years (range 5‐9)
MPH‐naive: not stated
Ethnicity: not stated
Country: not stated
Setting: outpatient clinic
Comorbidity: not stated
Comedication: not stated
IQ: 116
Other sociodemographics: all children living at home with ≥ 1 parent. No significant differences in age and IQ between treatment groups. No data on remaining parameters
Inclusion criteria
  • 5‐9 years of age

  • Fit DSM‐III criteria for ADD‐H, showing overactivity, short attention span, impulsivity, aggressiveness and oppositional behaviour, both at home and in school, since before 4 years of age

  • Hyperactivity Index of CTRS ≥ 15

  • IQ > 85


Exclusion criteria
  • Brain damage

  • Epilepsy

  • Psychosis

Interventions Participants were randomly assigned to MPH + parent training (intervention group) or to placebo + parent training (control group). After the titration period MPH was given only on school days
Average MPH dosage: 22 mg/d (range 10 mg/d‐30 mg/d)
Titration period: first 3‐4 weeks: MPH was titrated (after randomisation), starting with 5 mg twice/d (morning, noon), 7 days a week
Treatment compliance: not stated
Outcomes ADHD symptoms
  • CTRS 2, CPRS subscale

  • Hyperactivity Index: rated by mothers post‐treatment

Notes Ethics approval: no information
Key conclusions of trial authors
  • All groups showed improvement at home and in school; only with MPH administration were gains in measures of attention and impulse control also seen

  • Results also revealed greater improvement in academic achievement and in classroom behaviour in medication groups as compared with placebo groups

  • No evidence showed significant benefit from the addition of parent training to administration of medication


Comment from review authors
  • First trial author has retired; we were not able to get data from him (e.g. protocol, randomisation method)


Inclusion of MPH responders only/exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no
Any withdrawals due to AEs: yes, 4 participants responded adversely and were dropped from the trial
Funding source: Ministry of Health
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Children were randomly assigned; no description of how
Allocation concealment (selection bias) Unclear risk No data
Blinding of participants and personnel (performance bias)
All outcomes Low risk Parents, teachers, therapists and those testing the children were unaware of medication conditions
Blinding of outcome assessment (detection bias)
All outcomes Low risk Parents, teachers, therapists and those testing the children were unaware of medication conditions
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No data
Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): none
Selective reporting (reporting bias) Unclear risk No protocol identified