Attention Management Trial for Children With FASD - a N-of-1 Control Trial of Prescribed Stimulants for ADHD in FASD

Trial Information
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4

This study is a double-blind, placebo controlled, series of N-of-1 trials of individualised stimulant dose on ADHD symptomatology in children with FASD. The broad aim of this study is to contribute new evidence towards understanding treatment efficacy for ADHD symptoms in FASD. Specific aims are: To assess the ongoing effectiveness of stimulant medication prescribed for ADHD symptoms in individual children with FASD of clinically prescribed stimulant medication compared to placebo to control ADHD symptoms (using behavioural and cognitive measures) in children with FASD and ADHD using a N-of-1 trial design. To obtain pilot data to examine feasibility and tolerability of the planned N-of-1 trial design in children with FASD and ADHD for future and larger studies that might seek to examine if the different stimulant types are equally effective relative to placebo. To review the multiple N-of-1 data to analyze key individual factors that mediate the effect of stimulants relative to placebo on ADHD symptoms, including underlying child factors (attention skills, cognitive function), sociodemographic factors and other prenatal exposures.

Am I eligible for this trial?
Participation Requirements
Minimum Age:
Maximum Age:
Healthy Volunteers:

• 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'.

Where is this trial taking place?
Other Locations
Monash Health
Who do I contact about this trial?
Alison Crichton, PhD
Katrina Williams, PhD
- +61 3 8572 2602
When is this trial taking place?
Start Date: February 14, 2022
Estimated Completion Date: December 2022
How many participants will be in this trial?
Target number of participants: 20
What treatment is being studied in this trial?
Placebo Comparator: Placebo comparator 2
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.
Experimental: Stimulant
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).
Who are the authors of this trial?
What other conditions are being studied in this trial?

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