Table 2

Inclusion and exclusion criteria

InclusionExclusion criteria
  • Paediatric patient of VicFAS (aged 4–18 years at the time of randomisation).

  • Meet the diagnostic criteria for FASD or ‘at risk’ of FASD according to the Australian guide to the diagnosis of FASD.

  • Have confirmed prenatal alcohol exposure.

  • Meet the diagnostic criteria for ADHD (DSM-IV criteria).

  • Be currently prescribed (for at least 1 month prior to trial start) a stimulant medication for the treatment of ADHD symptoms.

  • Provide signed consent from the legal guardian.

  • Signed consent to be approached for future research (VicFAS database).

  • Inability to read or speak sufficient English for either the child or parent or guardian to complete assessment tasks.

  • Currently prescribed a medication for treatment of ADHD symptoms other than stimulants.*

  • Allergy or sensitivity to Starcke 1500 (maize starch and pregelatinised maize starch).*

  • Inability to swallow capsules.*

  • Intracranial symptoms or pathology, such as epilepsy, hydrocephalus, diagnosed traumatic. brain injury or progressive intracranial tumours that may impact cognitive and behavioural function (children with asymptomatic or static lesions will be eligible).*

  • An abnormal ECG result at the time of screening was deemed clinically significant by the participant’s paediatrician.*

  • The presence of a significant comorbid psychiatric or psychological disorder (excluding ADHD, oppositional defiant disorder, conduct disorder, pervasive development disorder or autism spectrum disorder), including depressive disorder, anxiety disorder, psychotic disorder, suicidality, Tic disorder, anorexia or bulimia nervosa, predominates their profile and makes them clinically unsuitable to participate.*

  • Treatment with any other investigational drug within 8 weeks prior to randomisation.*

  • Is known to be pregnant.*

  • Is deemed by their primary paediatrician to be medically unsafe for trial participation for any reason.*

  • Parents or guardians are not consenting for researchers to contact the participant’s paediatrician or school.

  • The child’s school is unwilling to participate in outcome assessments.

  • Criteria with an asterisk will be discussed with the participants’ ongoing paediatrician to ensure suitability for the study.

  • ADHD, attention deficit hyperactivity disorder; DMS-IV, Diagnostic and Statistical Manual of Mental Disorders, fourth edition; FASD, fetal alcohol spectrum disorder; VicFAS, Victorian fetal alcohol service.