This study identified aspects of the Alert Program training, delivery and measures for evaluation that need modification before their use in assessing the efficacy of the Alert Program in remote Aboriginal community primary schools.

Executive functioning and self-regulation influence a range of outcomes across the life course including physical and mental health, educational success, and employment. Children prenatally exposed to alcohol or early life trauma (ELT) are at higher risk of impairment of these skills and may require intervention to address self-regulation deficits. Researchers partnered with the local Aboriginal health organization and schools to develop and pilot a manualized version of the Alert Program® in the Fitzroy Valley, north Western Australia, a region with documented high rates of fetal alcohol spectrum disorder and ELT. This selfcontrolled cluster randomized trial evaluated the effect of an 8-week Alert Program® intervention on children's executive functioning and self-regulation skills. Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study. This reflects a 75% participation rate and indicates the strong community support that exists for the study. Teachers from 26 primary school classrooms across eight Fitzroy Valley schools received training to deliver eight, one-hour Alert Program® lessons over eightweeks to students. Student outcomes were measured by parent and teacher ratings of children's behavioral, emotional, and cognitive regulation. The mean number of lessons

Self-regulation and executive functioning impairments are common in children with fetal alcohol spectrum disorder. Given the high rates of fetal alcohol spectrum disorder identified amongst children living in the remote Fitzroy Valley region of Western Australia, the Alert Program V R was identified as a culturally safe intervention for use in local primary schools. Researchers collaborated with Aboriginal Elders, community members, and staff from a Fitzroy Valley primary school to trial the Alert Program V R. Teachers were trained to deliver eight Alert Program V R lessons to children in class. Self-regulation and executive functioning were measured using teacher and parent/caregiver questionnaires three times. Data were analyzed using repeated-measures ANOVA. Teacher-led delivery of the Alert Program V R was feasible in a region with high fetal alcohol spectrum disorder rates. As measured by teacher and parent/caregiver ratings, this curriculum may improve the self-regulation and executive functioning of children for some outcomes and provide sustained effects for some children. This community partnered pilot research, evaluated a school-based program to reduce the behavioral impact of fetal alcohol spectrum disorder, and informed design of a larger trial across eight Aboriginal community schools.

IntroductionWhile research highlights the benefits of early diagnosis and intervention for children with fetal alcohol spectrum disorders (FASD), there are limited data documenting effective interventions for Australian children living in remote communities.Methods and analysisThis self-controlled cluster randomised trial is evaluating the effectiveness of an 8-week Alert Program school curriculum for improving self-regulation and executive function in children living in remote Australian Aboriginal communities. Children in grades 1–6 attending any of the eight participating schools across the Fitzroy Valley in remote North-West Australia (N ≈ 363) were invited to participate. Each school was assigned to one of four clusters with clusters randomly assigned to receive the intervention at one of four time points. Clusters two, three and four had extended control conditions where students received regular schooling before later receiving the intervention. Trained classroom teachers delivered the Alert Program to students in discrete, weekly, 1-hour lessons. Student outcomes were assessed at three time points. For the intervention condition, data collection occurred 2 weeks immediately before and after the intervention, with a follow-up 8 weeks later. For control conditions in clusters two to four, the control data collection matched that of the data collection for the intervention condition in the preceding cluster. The primary outcome is change in self-regulation. FASD diagnoses will be determined via medical record review after the completion of data collection. The results will be analysed using generalised linear mixed modelling and reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines.Ethics and disseminationEthical approval was obtained from the University of Western Australia (WA) (RA/4/1/7234), WA Aboriginal Health Ethics Committee (601) and WA Country Health Service (2015:04). The Kimberley Aboriginal Health Planning Forum Research Sub-Committee and WA Department of Education also provided approval. The results will be disseminated through peer-reviewed journals, conference presentations, the media and at forums.Trial registration numberACTRN12615000733572; Pre-results.