Project Details

Attention management trial for children with FASD – a N-of-1 control trial of prescribed stimulants for ADHD in FASD

Alison Crichton, PhD

Summary

BACKGROUND: Fetal Alcohol Spectrum Disorder (FASD) is a neuro-developmental disorder caused by alcohol exposure during pregnancy that occurs in around 1.8% of school aged children. Children with FASD experience disruption to their neurodevelopment, and attention if often affected. GAP: Attention problems are a hallmark feature of prenatal alcohol exposure. Between 50-94 % of children with FASD meet diagnostic criteria for ADHD and experience difficult with concentration and focus. Despite the frequency of this comorbidity, there is a paucity of sufficient evidence on best psychotropic medication choice in the treatment of those with FASD (which) is unsatisfactory and leaves patients vulnerable. The aim of the Fetal Alcohol Spectrum Stimulant N-of-1 Trial is to conduct a series of N-of-1 trials for ADHD medication in children with ADHD and FASD to assess: 1. feasibility and acceptability of N-of-1 trial methods and the FASST study design 2. preliminary effectiveness data to inform sample size and frequency and duration of intervention/placebo cycles for future studies. HYPOTHESIS: First, we anticipate that the trial will be acceptable and feasible to the majority of participants, although this may not be possible or ideal in some participant circumstances. Second, we anticipate behavioral ratings of child hyperactivity will be significantly lower on Psychostimulant than placebo conditions, but that child cognitive assessment of attention will be less sensitive to medication effects. We further anticipate that risk factors such as attention skill deficits that are atypical to ADHD and greater extent/breadth of neurodevelopmental impairment, greater neurotoxin exposure (high alcohol exposure and exposure to other neurotoxins), and lower socioeconomic status will be associated with less response to treatment. METHODS: This is an investigator-initiated series of N-of-1 cross-over randomized control trials of existing ADHD stimulant medication in children with diagnosed FASD and ADHD. RESULTS: Pending IMPACT: ADHD symptoms are a common comorbidity for children with FASD, yet management of this issue is not well informed by current available evidence. Findings from this study will help inform medication management of ADHD in FASD, and will provide important preliminary data towards future studies and research collaborations in this area.

Publications: