FASST - Fetal Alcohol Spectrum Stimulant Trial (FASST)
Fetal Alcohol Spectrum Disorders
About this trial
This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders focused on measuring Attention Deficit Hyperactivity Disorder, Stimulants, Trial, Attention
Eligibility Criteria
Inclusion Criteria:
Each patient must meet all of the following criteria to be enrolled in this trial:
- Is between the ages of 4 - 18 years at the time of randomization.
- Meet diagnostic criteria for FASD or at risk of FASD according to the Australian Guide to the diagnosis of FASD.
- Is a patient of VicFAS or Developmental Paediatrics (Monash Health).
- Has a diagnosis of ADHD according to the DMS-IV criteria.
- Be on a stimulant medication for treatment of ADHD symptoms.
- Be on a stimulant medication as a primary treatment for ADHD.
- Be on a stable dose of stimulant medication for at last 1 month prior to the study.
- Provide a signed and dated informed consent form / and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
- If seen by VicFAS/Developmental paediatrics between August 2019 - study commencement date), parent/guardian must have provided verbal or written consent to the VicFAS database PICF and selected 'yes' to the optional consent for contact for 'future research'.
Exclusion Criteria:
Exclusion criteria will include any of the following:
- Inability to read or speak sufficient English for either child or parent/guardian to complete assessment tasks.
- Be on a medication for treatment of ADHD symptoms that is a medication other than stimulants as a primary treatment for ADHD.
- Allergy/sensitivity to Starcke 1500 (Maize Starch and Pregelatinised Maize Starch).
- Unable 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 deemed clinically significant by study physician.
- Presence of a significant comorbid psychiatric or psychological (excluding ADHD, oppositional defiant disorder, conduct disorder and pervasive development disorder/autism spectrum disorder) including depressive disorder, anxiety disorder, psychotic disorder, suicidality, Tic disorder, anorexia or bulimia nervosa
- Has a known hypersensitivity to starch or other compound relevant to placebo/capsules.
- Has had treatment with any other investigational drug within 4 weeks prior to randomisation.
- If the participant is known to be pregnant, they cannot take part in this research project.
- Parent/guardian not consenting to contact with paediatrician or school.
- Is deemed by their treating paediatrician to be medically unsafe for trial participation.
- Child's school unwilling to participate in outcome assessments.
Sites / Locations
- Monash HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo comparator 2
Stimulant
Participants will be allocated a randomly allocated sequence of treatment. The randomisation will be in two-week pairs - so the order of treatment (A) and placebo (P) to be randomly assigned within each two-week cycle (over 8 weeks). Placebo will be matched in dose to their stimulant dose at enrolment to the trial as determined and titrated by their primary paediatrician. This dose will remain constant for the course of the trial (8 weeks). Placebo will be orally administered, unless this is not possible for clinical reasons.
The stimulants used in the trial are commercially available and will be used in accordance with the approved labelling. Participants must be on a stable dose of stimulant medication for at last 1 month prior to the study. The dose is individualized and titrated by treating primary paediatrician. This will represent the starting dose for the trial, and this will remain stable through the course of the 8-week trial. This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. Based on pilot data from this group, psychostimulant medications prescribed in this population may include: Methylphenidate IR Methylphenidate LA Dexamphetamine Children will take the required number of capsules to match the total prescribed dose (e.g. 30mg Ritalin LA is 3x10mg capsules).