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

Heriot 2008.

Study characteristics
Methods 3‐month, parallel trial with 4 arms
  • MPH and parent training programme

  • MPH and supportive non‐training parent group

  • Placebo and parent training

  • Placebo and supportive non‐training parent group

Participants Number of participants screened: 93
Number of participants included: 20‐26 (13 boys, 3 girls) (6 withdrew, but unclear whether before or after random assignment)
Number of participants followed up: MPH + parent training 4, MPH + no training 4, placebo + training 4, placebo + no training 4
Number of withdrawals: not stated
Diagnosis of ADHD: DSM‐IV (combined (25%), hyperactive‐impulsive (56%), inattentive (19%))
Age: mean 4.78 years (range 3‐6)
IQ: mean 97 (range 80‐123)
MPH‐naive: 100%
Ethnicity: not stated
Country: New Zealand
Setting: outpatient clinic
Comorbidity (type: ODD 5/31%)
Comedication: no
Other sociodemographics: No significant differences in baseline demographics were noted between the 4 intervention groups.
Inclusion criteria
  • Between 3.0‐5.9 years of age

  • Resident with a primary caregiver for ≥ 6 months

  • Meet diagnostic criteria for ADHD as defined in DSM‐IV

  • Features of ADHD had to be present for ≥ 12 months and to a degree that was considered to be developmentally inappropriate and functionally inappropriate and functionally impairing across settings

  • Above the 93rd percentile on the Global Index subscale of the CRS


Exclusion criteria
  • Currently in hospital

  • Currently in another treatment trial

  • Currently receiving treatment

  • Full scale IQ < 80

  • Pervasive developmental disorder or psychosis

  • Major neurological or medical illness that would interfere with participation or require medications incompatible with MPH

  • Chronic serious tics or Tourette’s disorder

  • History of child abuse

  • Inability of parent to understand English

Interventions Participants were randomly assigned to MPH + parent training, MPH + no parent training, placebo + parent training or placebo + no parent training
Number randomised to each group: not stated
Mean MPH dosage: 0.3 mg/kg
Administration schedule: twice/d ‐ morning and lunchtime
Duration of intervention: 3 months
Titration period: dosage was built up over the 1st week
Treatment compliance: not stated
Outcomes ADHD symptoms
  • ADHD‐RS‐IV Parent and Teacher versions: data not reported in an useable form ‐ not possible to obtain data from trial author

  • CPRS ‐ Revised, Long Version: no data provided in the article

  • CTRS ‐ Revised, Long Version: no data provided in the article


Non‐serious AEs
  • Stimulant drug, Barkley Side Effects Rating Scale

Notes Sample calculation: no
Ethics approval: yes; obtained from the University of Waikato, Department of Psychology Ethical Review Committee and the Waikato Ethics Committee for Waikato Hospital
Comments from trial authors
  • 7 of the 16 children no longer met DSM‐IV (1994) diagnostic criteria for ADHD at the end of the trial

  • Ethnicity did not appear to affect outcomes, although it was unclear whether the content of the programme was equally appropriate for all ethnic groups

  • Limitations

    • Small number of participants

    • Of those willing to participate, only 43% met eligibility criteria for the trial

    • No follow‐up data


Key conclusion of trial authors
  • Children were more likely to improve when treatment involved ≥ 1 active component (medication or parent training). However, variability in individual parental and child participant responses to all treatment conditions was notable, indicating the importance of interaction between treatment variables and other factors. Findings are discussed within the framework of a transactional model, and inferences are drawn about limitations of the idea that a "best treatment" exists that is universally applicable. Although improvement among children receiving treatment with MPH was greater than for others, it is notable that all treatments were associated with improvement in some children.


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no
Any withdrawals due to AEs: unclear
Funding source: no funding to conduct the trial was received from any party
Email correspondence with trial authors: January, February and May 2014. Emailed trial author but have not received a reply
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Participants were allocated to conditions sequentially, using RAND function (SPSS) to generate the sequence. Each parent was randomly assigned to attend the training programme group or the support group.
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes Low risk Throughout the period of data collection, participants and therapist were blinded to medication status
Blinding of outcome assessment (detection bias)
All outcomes Low risk Throughout the period of data collection, participants and therapist were blinded to medication status. All parents and teachers were blinded to the intervention
Incomplete outcome data (attrition bias)
All outcomes High risk Only data for completing participants were reported
Selection bias (e.g. titration after randomisation → exclusion): unclear. 4 were excluded after randomisation because of "treatment integrity problems"
Selective reporting (reporting bias) Unclear risk We were unable to identify a protocol