Heriot 2008.
Study characteristics | ||
Methods | 3‐month, parallel trial with 4 arms
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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
Exclusion criteria
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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 |
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Outcomes |
ADHD symptoms
Non‐serious AEs
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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
Key conclusion of trial authors
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 |
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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 |